Difference between revisions of "Prostate cancer"
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===References=== | ===References=== | ||
− | # Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. [http://jco.ascopubs.org/content/15/3/1013.long link to original article] '''contains protocol''' [ | + | # Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. [http://jco.ascopubs.org/content/15/3/1013.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9060541 PubMed] |
− | ## '''Update:''' Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. [http://www.redjournal.org/article/S0360-3016%2800%2901516-9/fulltext link to original article] '''contains protocol''' [ | + | ## '''Update:''' Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. [http://www.redjournal.org/article/S0360-3016%2800%2901516-9/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11240234 PubMed] |
− | ## '''Update:''' Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. [http://www.redjournal.org/article/S0360-3016(04)02468-X/abstract link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. [http://www.redjournal.org/article/S0360-3016(04)02468-X/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15817329 PubMed] |
− | # Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. [http://www.nejm.org/doi/full/10.1056/NEJM199707313370502 link to original article] [ | + | # Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. [http://www.nejm.org/doi/full/10.1056/NEJM199707313370502 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9233866 PubMed] |
==Goserelin, Flutamide, RT {{#subobject:2 |Regimen=1}}== | ==Goserelin, Flutamide, RT {{#subobject:2 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. [http://www.sciencedirect.com/science/article/pii/S0360301601015796 link to original article] '''contains verified protocol''' [ | + | # Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. [http://www.sciencedirect.com/science/article/pii/S0360301601015796 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11483335 PubMed] |
− | ## '''Update:''' Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. [http://jco.ascopubs.org/content/26/4/585.long link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. [http://jco.ascopubs.org/content/26/4/585.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18172188 PubMed] |
− | # Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. [http://jco.ascopubs.org/content/21/21/3972.long link to original article] '''contains protocol''' [ | + | # Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. [http://jco.ascopubs.org/content/21/21/3972.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14581419 PubMed] |
− | ## '''Update:''' Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. [http://jco.ascopubs.org/content/26/15/2497.long link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. [http://jco.ascopubs.org/content/26/15/2497.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18413638 PubMed] |
− | # Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. [http://www.sciencedirect.com/science/article/pii/S147020450570348X link to original article] '''contains protocol''' [ | + | # Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. [http://www.sciencedirect.com/science/article/pii/S147020450570348X link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16257791 PubMed] |
− | # D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. [http://jama.ama-assn.org/content/299/3/289.long link to original article] [ | + | # D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. [http://jama.ama-assn.org/content/299/3/289.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18212313 PubMed] content property of [http://hemonc.org HemOnc.org] |
− | # Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 link to original article] '''contains verified protocol''' [ | + | # Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21751904 PubMed] |
==Leuprolide, Flutamide, RT {{#subobject:3 |Regimen=1}}== | ==Leuprolide, Flutamide, RT {{#subobject:3 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 link to original article] '''contains verified protocol''' [ | + | # Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21751904 PubMed] |
==RT {{#subobject:4 |Regimen=1}}== | ==RT {{#subobject:4 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. [http://jco.ascopubs.org/content/15/3/1013.long link to original article] '''contains protocol''' [ | + | # Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. [http://jco.ascopubs.org/content/15/3/1013.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9060541 PubMed] |
− | ## '''Update:''' Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. [http://www.redjournal.org/article/S0360-3016%2800%2901516-9/fulltext link to original article] '''contains protocol''' [ | + | ## '''Update:''' Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. [http://www.redjournal.org/article/S0360-3016%2800%2901516-9/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11240234 PubMed] |
− | ## '''Update:''' Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. [http://www.redjournal.org/article/S0360-3016(04)02468-X/abstract link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. [http://www.redjournal.org/article/S0360-3016(04)02468-X/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15817329 PubMed] |
− | # Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. [http://www.nejm.org/doi/full/10.1056/NEJM199707313370502 link to original article] [ | + | # Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. [http://www.nejm.org/doi/full/10.1056/NEJM199707313370502 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9233866 PubMed] |
− | # Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. [http://www.redjournal.org/article/S0360-3016(01)01579-6/abstract link to original article] '''contains verified protocol''' [ | + | # Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. [http://www.redjournal.org/article/S0360-3016(01)01579-6/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11483335 PubMed] |
− | ## '''Update:''' Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. [http://jco.ascopubs.org/content/26/4/585.long link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. [http://jco.ascopubs.org/content/26/4/585.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18172188 PubMed] |
− | # Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(05)70348-X/abstract link to original article] '''contains protocol''' [ | + | # Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(05)70348-X/abstract link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16257791 PubMed] |
− | # D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. [http://jama.ama-assn.org/content/299/3/289.long link to original article] [ | + | # D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. [http://jama.ama-assn.org/content/299/3/289.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18212313 PubMed] content property of [http://hemonc.org HemOnc.org] |
− | # Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 link to original article] '''contains verified protocol''' [ | + | # Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21751904 PubMed] |
=Hormonal therapy, adjuvant= | =Hormonal therapy, adjuvant= | ||
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===References=== | ===References=== | ||
− | # Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. [http://jco.ascopubs.org/content/21/21/3972.long link to original article] '''contains protocol''' [ | + | # Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. [http://jco.ascopubs.org/content/21/21/3972.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14581419 PubMed] |
− | ## '''Update:''' Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. [http://jco.ascopubs.org/content/26/15/2497.long link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. [http://jco.ascopubs.org/content/26/15/2497.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18413638 PubMed] |
==Observation== | ==Observation== | ||
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===References=== | ===References=== | ||
− | # Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. [http://jco.ascopubs.org/content/21/21/3972.long link to original article] '''contains protocol''' [ | + | # Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. [http://jco.ascopubs.org/content/21/21/3972.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14581419 PubMed] |
− | ## '''Update:''' Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. [http://jco.ascopubs.org/content/26/15/2497.long link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. [http://jco.ascopubs.org/content/26/15/2497.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18413638 PubMed] |
=Hormonal therapy, metastatic or locally advanced disease= | =Hormonal therapy, metastatic or locally advanced disease= | ||
Line 265: | Line 265: | ||
===References=== | ===References=== | ||
− | # Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. Epub 2015 Aug 5. [http://www.nejm.org/doi/full/10.1056/NEJMoa1503747 link to original article] '''contains verified protocol''' [ | + | # Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. Epub 2015 Aug 5. [http://www.nejm.org/doi/full/10.1056/NEJMoa1503747 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26244877 Pubmed] |
==Bicalutamide (Casodex) {{#subobject:5 |Regimen=1}}== | ==Bicalutamide (Casodex) {{#subobject:5 |Regimen=1}}== | ||
Line 278: | Line 278: | ||
|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/9643663 Tyrrell et al. 1998] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Prostate_cancer#Castration|Castration]] | |[[Prostate_cancer#Castration|Castration]] | ||
Line 288: | Line 288: | ||
===References=== | ===References=== | ||
− | # Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. '''contains protocol''' [ | + | # Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9643663 PubMed] |
− | ## '''Update:''' Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. [http://www.sciencedirect.com/science/article/pii/S0022534705670322 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. [http://www.sciencedirect.com/science/article/pii/S0022534705670322 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11025708 PubMed] |
==Bicalutamide & Goserelin {{#subobject:10 |Regimen=1}}== | ==Bicalutamide & Goserelin {{#subobject:10 |Regimen=1}}== | ||
Line 327: | Line 327: | ||
===References=== | ===References=== | ||
− | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [ | + | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7538237 PubMed] |
− | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [ | + | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8918410 PubMed] |
− | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [ | + | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8717471 PubMed] |
− | # Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. [http://jjco.oxfordjournals.org/content/34/1/20.full link to original article] '''contains verified protocol''' [ | + | # Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. [http://jjco.oxfordjournals.org/content/34/1/20.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15020659 PubMed] |
==Bicalutamide & Leuprolide {{#subobject:13 |Regimen=1}}== | ==Bicalutamide & Leuprolide {{#subobject:13 |Regimen=1}}== | ||
Line 368: | Line 368: | ||
===References=== | ===References=== | ||
− | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [ | + | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7538237 PubMed] |
− | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [ | + | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8918410 PubMed] |
− | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [ | + | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8717471 PubMed] |
− | # Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. [http://jjco.oxfordjournals.org/content/34/1/20.full link to original article] '''contains verified protocol''' [ | + | # Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. [http://jjco.oxfordjournals.org/content/34/1/20.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15020659 PubMed] |
==Castration {{#subobject:6 |Regimen=1}}== | ==Castration {{#subobject:6 |Regimen=1}}== | ||
Line 384: | Line 384: | ||
|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/1824732 Soloway et al. 1991 (Zoladex Prostate Study Group)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Prostate_cancer#Goserelin_.28Zoladex.29_2|Goserelin]] | |[[Prostate_cancer#Goserelin_.28Zoladex.29_2|Goserelin]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/1828183 Kaisary et al. 1991] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Prostate_cancer#Goserelin_.28Zoladex.29_2|Goserelin]] | |[[Prostate_cancer#Goserelin_.28Zoladex.29_2|Goserelin]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/7678043 Janknegt et al. 1993 (International Anandron Study Group)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Prostate_cancer#Nilutamide_.28Nilandron.29|Nilutamide & Orchiectomy]] | |[[Prostate_cancer#Nilutamide_.28Nilandron.29|Nilutamide & Orchiectomy]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/8367920 Denis et al. 1993 (EORTC 30853)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#Flutamide_.26_Goserelin|Flutamide & Goserelin]] | |[[#Flutamide_.26_Goserelin|Flutamide & Goserelin]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/9412794 Boccon-Gibod et al. 1997] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Prostate_cancer#Flutamide_.28Eulexin.29|Flutamide]] | |[[Prostate_cancer#Flutamide_.28Eulexin.29|Flutamide]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/9643663 Tyrrell et al. 1998] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Prostate_cancer#Bicalutamide_.28Casodex.29|Bicalutamide]] | |[[Prostate_cancer#Bicalutamide_.28Casodex.29|Bicalutamide]] | ||
Line 413: | Line 413: | ||
===References=== | ===References=== | ||
− | # Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. [ | + | # Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. [https://www.ncbi.nlm.nih.gov/pubmed/1824732 PubMed] |
− | ## '''Update:''' Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. [http://www.goldjournal.net/article/S0090-4295(99)80197-6/abstract link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. [http://www.goldjournal.net/article/S0090-4295(99)80197-6/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/7624991 PubMed] |
− | # Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. [ | + | # Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. [https://www.ncbi.nlm.nih.gov/pubmed/1828183 PubMed] |
− | # Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. [ | + | # Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. [https://www.ncbi.nlm.nih.gov/pubmed/7678043 PubMed] |
− | ## '''Update:''' Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. [ | + | ## '''Update:''' Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. [https://www.ncbi.nlm.nih.gov/pubmed/8252507 PubMed] |
− | ## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. [ | + | ## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. [https://www.ncbi.nlm.nih.gov/pubmed/9186345 PubMed] |
− | ## '''Update:''' de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. [http://www.europeanurology.com/article/S0302-2838%2802%2900272-5 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. [http://www.europeanurology.com/article/S0302-2838%2802%2900272-5 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/12160584 PubMed] |
− | # Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. '''contains protocol''' [ | + | # Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8367920 PubMed] |
− | ## '''Update:''' Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. [ | + | ## '''Update:''' Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. [https://www.ncbi.nlm.nih.gov/pubmed/9519355 PubMed] |
− | # Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5; discussion 395-6. '''contains protocol''' [ | + | # Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5; discussion 395-6. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9412794 PubMed] |
− | # Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. '''contains protocol''' [ | + | # Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9643663 PubMed] |
− | ## '''Update:''' Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. [http://www.sciencedirect.com/science/article/pii/S0022534705670322 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. [http://www.sciencedirect.com/science/article/pii/S0022534705670322 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11025708 PubMed] |
==Degarelix (Firmagon) {{#subobject:7 |Regimen=1}}== | ==Degarelix (Firmagon) {{#subobject:7 |Regimen=1}}== | ||
Line 464: | Line 464: | ||
===References=== | ===References=== | ||
− | # Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. [http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2008.08183.x/full link to original article] '''contains verified protocol''' [ | + | # Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. [http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2008.08183.x/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19035858 PubMed] |
− | ## '''Update:''' Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Crawford ED, Moul J, Jensen JK, Kold Olesen T, Persson BE. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010 May;57(5):836-42. Epub 2009 Nov 20. [http://www.europeanurology.com/article/S0302-2838%2809%2901171-3 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Crawford ED, Moul J, Jensen JK, Kold Olesen T, Persson BE. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010 May;57(5):836-42. Epub 2009 Nov 20. [http://www.europeanurology.com/article/S0302-2838%2809%2901171-3 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19962227 PubMed] |
==Flutamide (Eulexin) {{#subobject:8 |Regimen=1}}== | ==Flutamide (Eulexin) {{#subobject:8 |Regimen=1}}== | ||
Line 478: | Line 478: | ||
|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/9412794 Boccon-Gibod et al. 1997] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Prostate_cancer#Castration|Orchiectomy]] | |[[Prostate_cancer#Castration|Orchiectomy]] | ||
Line 488: | Line 488: | ||
===References=== | ===References=== | ||
− | # Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5; discussion 395-6. '''contains protocol''' [ | + | # Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5; discussion 395-6. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9412794 PubMed] |
==Flutamide & Goserelin {{#subobject:11 |Regimen=1}}== | ==Flutamide & Goserelin {{#subobject:11 |Regimen=1}}== | ||
Line 501: | Line 501: | ||
|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/8367920 Denis et al. 1993 (EORTC 30853)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#Castration|Bilateral orchiectomy]] | |[[#Castration|Bilateral orchiectomy]] | ||
Line 515: | Line 515: | ||
===References=== | ===References=== | ||
− | # Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. '''contains protocol''' [ | + | # Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8367920 PubMed] |
− | ## '''Update:''' Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. [ | + | ## '''Update:''' Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. [https://www.ncbi.nlm.nih.gov/pubmed/9519355 PubMed] |
− | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [ | + | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7538237 PubMed] |
− | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [ | + | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8918410 PubMed] |
− | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [ | + | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8717471 PubMed] |
==Flutamide & Leuprolide {{#subobject:14 |Regimen=1}}== | ==Flutamide & Leuprolide {{#subobject:14 |Regimen=1}}== | ||
Line 542: | Line 542: | ||
===References=== | ===References=== | ||
− | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [ | + | # Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. [http://www.goldjournal.net/article/S0090-4295(99)80077-6/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/7538237 PubMed] |
− | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [ | + | ## '''Update:''' Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. [http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0142(19961115)78:10%3C2164::AID-CNCR18%3E3.0.CO;2-X/abstract link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8918410 PubMed] |
− | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [ | + | ## '''Update:''' Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8717471 PubMed] |
==Goserelin (Zoladex) {{#subobject:9 |Regimen=1}}== | ==Goserelin (Zoladex) {{#subobject:9 |Regimen=1}}== | ||
Line 560: | Line 560: | ||
|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/1824732 Soloway et al. 1991 (Zoladex Prostate Study Group)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#Castration|Bilateral orchiectomy]] | |[[#Castration|Bilateral orchiectomy]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/1828183 Kaisary et al. 1991] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#Castration|Bilateral orchiectomy]] | |[[#Castration|Bilateral orchiectomy]] | ||
Line 573: | Line 573: | ||
===References=== | ===References=== | ||
− | # Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. [ | + | # Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. [https://www.ncbi.nlm.nih.gov/pubmed/1824732 PubMed] |
− | ## '''Update:''' Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. [http://www.goldjournal.net/article/S0090-4295(99)80197-6/abstract link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. [http://www.goldjournal.net/article/S0090-4295(99)80197-6/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/7624991 PubMed] |
− | # Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. [ | + | # Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. [https://www.ncbi.nlm.nih.gov/pubmed/1828183 PubMed] |
==Leuprolide (Lupron) {{#subobject:12 |Regimen=1}}== | ==Leuprolide (Lupron) {{#subobject:12 |Regimen=1}}== | ||
Line 649: | Line 649: | ||
===References=== | ===References=== | ||
− | # Sharifi R, Bruskewitz RC, Gittleman MC, Graham SD Jr, Hudson PB, Stein B. Leuprolide acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer. Clin Ther. 1996 Jul-Aug;18(4):647-57. [http://www.sciencedirect.com/science/article/pii/S0149291896802153 link to original article] '''contains verified protocol''' [ | + | # Sharifi R, Bruskewitz RC, Gittleman MC, Graham SD Jr, Hudson PB, Stein B. Leuprolide acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer. Clin Ther. 1996 Jul-Aug;18(4):647-57. [http://www.sciencedirect.com/science/article/pii/S0149291896802153 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879893 PubMed] |
− | # Sharifi R, Knoll LD, Smith J, Kramolowsky E. Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer. Urology. 1998 Feb;51(2):271-6. [http://www.sciencedirect.com/science/article/pii/S0090429597005001 link to original article] [ | + | # Sharifi R, Knoll LD, Smith J, Kramolowsky E. Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer. Urology. 1998 Feb;51(2):271-6. [http://www.sciencedirect.com/science/article/pii/S0090429597005001 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9495710 PubMed] |
− | # Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. [http://jjco.oxfordjournals.org/content/34/1/20.full link to original article] '''contains verified protocol''' [ | + | # Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. [http://jjco.oxfordjournals.org/content/34/1/20.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15020659 PubMed] |
− | # Loblaw DA, Virgo KS, Nam R, Somerfield MR, Ben-Josef E, Mendelson DS, Middleton R, Sharp SA, Smith TJ, Talcott J, Taplin M, Vogelzang NJ, Wade JL 3rd, Bennett CL, Scher HI; American Society of Clinical Oncology. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007 Apr 20;25(12):1596-605. Epub 2007 Apr 2. [http://jco.ascopubs.org/content/25/12/1596.long link to original article] [ | + | # Loblaw DA, Virgo KS, Nam R, Somerfield MR, Ben-Josef E, Mendelson DS, Middleton R, Sharp SA, Smith TJ, Talcott J, Taplin M, Vogelzang NJ, Wade JL 3rd, Bennett CL, Scher HI; American Society of Clinical Oncology. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007 Apr 20;25(12):1596-605. Epub 2007 Apr 2. [http://jco.ascopubs.org/content/25/12/1596.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/17404365 PubMed] |
− | # Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. [http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2008.08183.x/full link to original article] '''contains verified protocol''' [ | + | # Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. [http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2008.08183.x/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19035858 PubMed] |
− | ## '''Update:''' Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Crawford ED, Moul J, Jensen JK, Kold Olesen T, Persson BE. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010 May;57(5):836-42. Epub 2009 Nov 20. [http://www.europeanurology.com/article/S0302-2838%2809%2901171-3 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Crawford ED, Moul J, Jensen JK, Kold Olesen T, Persson BE. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010 May;57(5):836-42. Epub 2009 Nov 20. [http://www.europeanurology.com/article/S0302-2838%2809%2901171-3 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19962227 PubMed] |
− | # Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. Epub 2015 Aug 5. [http://www.nejm.org/doi/full/10.1056/NEJMoa1503747 link to original article] '''contains verified protocol''' [ | + | # Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. Epub 2015 Aug 5. [http://www.nejm.org/doi/full/10.1056/NEJMoa1503747 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26244877 Pubmed] |
==Nilutamide & Orchiectomy {{#subobject:15 |Regimen=1}}== | ==Nilutamide & Orchiectomy {{#subobject:15 |Regimen=1}}== | ||
Line 668: | Line 668: | ||
|'''Comparator''' | |'''Comparator''' | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pubmed/7678043 Janknegt et al. 1993 (International Anandron Study Group)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#Castration|Orchiectomy]] | |[[#Castration|Orchiectomy]] | ||
Line 678: | Line 678: | ||
===References=== | ===References=== | ||
− | # Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. [ | + | # Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. [https://www.ncbi.nlm.nih.gov/pubmed/7678043 PubMed] |
− | ## '''Update:''' Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. [ | + | ## '''Update:''' Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. [https://www.ncbi.nlm.nih.gov/pubmed/8252507 PubMed] |
− | ## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. [ | + | ## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. [https://www.ncbi.nlm.nih.gov/pubmed/9186345 PubMed] |
− | ## '''Update:''' de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. [http://www.europeanurology.com/article/S0302-2838%2802%2900272-5 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. [http://www.europeanurology.com/article/S0302-2838%2802%2900272-5 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/12160584 PubMed] |
# [http://products.sanofi.us/nilandron/nilandron.pdf Nilutamide (Nilandron) package insert] | # [http://products.sanofi.us/nilandron/nilandron.pdf Nilutamide (Nilandron) package insert] | ||
Line 719: | Line 719: | ||
===References=== | ===References=== | ||
− | # de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. [http://www.nejm.org/doi/full/10.1056/NEJMoa1014618 link to original article] '''contains verified protocol''' [ | + | # de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. [http://www.nejm.org/doi/full/10.1056/NEJMoa1014618 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21612468 PubMed] |
− | ## '''Update:''' Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. Epub 2012 Sep 18. [http://www.sciencedirect.com/science/article/pii/S1470204512703790 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. Epub 2012 Sep 18. [http://www.sciencedirect.com/science/article/pii/S1470204512703790 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22995653 PubMed] |
− | ## '''Update:''' Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. Epub 2012 Nov 9. [http://www.sciencedirect.com/science/article/pii/S1470204512704734 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. Epub 2012 Nov 9. [http://www.sciencedirect.com/science/article/pii/S1470204512704734 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23142059 PubMed] |
− | # Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. Epub 2012 Dec 10. [http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 link to original article] '''contains verified protocol''' [ | + | # Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. Epub 2012 Dec 10. [http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23228172 PubMed] |
==Antiandrogen withdrawal {{#subobject:17 |Regimen=1}}== | ==Antiandrogen withdrawal {{#subobject:17 |Regimen=1}}== | ||
Line 744: | Line 744: | ||
===References=== | ===References=== | ||
− | # Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, Gable P, Torti FM, Kaplan E, Vogelzang NJ. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol. 2004 Mar 15;22(6):1025-33. [http://jco.ascopubs.org/content/22/6/1025.long link to original article] '''contains verified protocol''' [ | + | # Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, Gable P, Torti FM, Kaplan E, Vogelzang NJ. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol. 2004 Mar 15;22(6):1025-33. [http://jco.ascopubs.org/content/22/6/1025.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15020604 PubMed] |
==Bicalutamide (Casodex) {{#subobject:abb40a |Regimen=1}}== | ==Bicalutamide (Casodex) {{#subobject:abb40a |Regimen=1}}== | ||
Line 776: | Line 776: | ||
===References=== | ===References=== | ||
<!-- Presented in part at the American Urological Association 2015 Annual Meeting, New Orleans, LA, May 15-19, 2015. --> | <!-- Presented in part at the American Urological Association 2015 Annual Meeting, New Orleans, LA, May 15-19, 2015. --> | ||
− | # Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. Epub 2016 Jan 25. [http://jco.ascopubs.org/content/34/18/2098.full link to original article] '''contains protocol''' [ | + | # Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. Epub 2016 Jan 25. [http://jco.ascopubs.org/content/34/18/2098.full link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26811535 PubMed] |
==Enzalutamide (Xtandi) {{#subobject:18 |Regimen=1}}== | ==Enzalutamide (Xtandi) {{#subobject:18 |Regimen=1}}== | ||
Line 821: | Line 821: | ||
===References=== | ===References=== | ||
− | # Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. [http://www.nejm.org/doi/full/10.1056/NEJMoa1207506 link to original article] '''contains verified protocol''' [ | + | # Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. [http://www.nejm.org/doi/full/10.1056/NEJMoa1207506 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22894553 PubMed] |
<!-- # Beer TM, Armstrong AJ, Sternberg CN, Higano CS, Iversen P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. ASCO Meeting Abstracts. 2014 February 5, 2014;32(4_suppl):LBA1. [http://abstracts.asco.org/142/AbstView_142_123836.html link to original article] '''contains verified protocol''' --> | <!-- # Beer TM, Armstrong AJ, Sternberg CN, Higano CS, Iversen P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. ASCO Meeting Abstracts. 2014 February 5, 2014;32(4_suppl):LBA1. [http://abstracts.asco.org/142/AbstView_142_123836.html link to original article] '''contains verified protocol''' --> | ||
− | # Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. [http://www.nejm.org/doi/full/10.1056/NEJMoa1405095 link to original article] [ | + | # Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. [http://www.nejm.org/doi/full/10.1056/NEJMoa1405095 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24881730 PubMed] |
<!-- Presented in part at the American Urological Association 2015 Annual Meeting, New Orleans, LA, May 15-19, 2015. --> | <!-- Presented in part at the American Urological Association 2015 Annual Meeting, New Orleans, LA, May 15-19, 2015. --> | ||
− | # Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. Epub 2016 Jan 25. [http://jco.ascopubs.org/content/34/18/2098.full link to original article] '''contains protocol''' [ | + | # Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. Epub 2016 Jan 25. [http://jco.ascopubs.org/content/34/18/2098.full link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26811535 PubMed] |
==Ketoconazole & Hydrocortisone {{#subobject:19 |Regimen=1}}== | ==Ketoconazole & Hydrocortisone {{#subobject:19 |Regimen=1}}== | ||
Line 854: | Line 854: | ||
===References=== | ===References=== | ||
− | # Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, Gable P, Torti FM, Kaplan E, Vogelzang NJ. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol. 2004 Mar 15;22(6):1025-33. [http://jco.ascopubs.org/content/22/6/1025.long link to original article] '''contains verified protocol''' [ | + | # Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, Gable P, Torti FM, Kaplan E, Vogelzang NJ. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol. 2004 Mar 15;22(6):1025-33. [http://jco.ascopubs.org/content/22/6/1025.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15020604 PubMed] |
==Ketoconazole, Hydrocortisone, Dutasteride {{#subobject:20 |Regimen=1}}== | ==Ketoconazole, Hydrocortisone, Dutasteride {{#subobject:20 |Regimen=1}}== | ||
Line 876: | Line 876: | ||
===References=== | ===References=== | ||
− | # Taplin ME, Regan MM, Ko YJ, Bubley GJ, Duggan SE, Werner L, Beer TM, Ryan CW, Mathew P, Tu SM, Denmeade SR, Oh WK, Sartor O, Mantzoros CS, Rittmaster R, Kantoff PW, Balk SP. Phase II study of androgen synthesis inhibition with ketoconazole, hydrocortisone, and dutasteride in asymptomatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Nov 15;15(22):7099-105. Epub 2009 Nov 3. [http://clincancerres.aacrjournals.org/content/15/22/7099.long link to original article] '''contains verified protocol''' [ | + | # Taplin ME, Regan MM, Ko YJ, Bubley GJ, Duggan SE, Werner L, Beer TM, Ryan CW, Mathew P, Tu SM, Denmeade SR, Oh WK, Sartor O, Mantzoros CS, Rittmaster R, Kantoff PW, Balk SP. Phase II study of androgen synthesis inhibition with ketoconazole, hydrocortisone, and dutasteride in asymptomatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Nov 15;15(22):7099-105. Epub 2009 Nov 3. [http://clincancerres.aacrjournals.org/content/15/22/7099.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19887483 PubMed] |
==Placebo== | ==Placebo== | ||
Line 902: | Line 902: | ||
===References=== | ===References=== | ||
− | # Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. [http://www.nejm.org/doi/full/10.1056/NEJMoa1207506 link to original article] '''contains verified protocol''' [ | + | # Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. [http://www.nejm.org/doi/full/10.1056/NEJMoa1207506 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22894553 PubMed] |
<!-- # Beer TM, Armstrong AJ, Sternberg CN, Higano CS, Iversen P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. ASCO Meeting Abstracts. 2014 February 5, 2014;32(4_suppl):LBA1. [http://abstracts.asco.org/142/AbstView_142_123836.html link to original article] '''contains verified protocol''' --> | <!-- # Beer TM, Armstrong AJ, Sternberg CN, Higano CS, Iversen P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. ASCO Meeting Abstracts. 2014 February 5, 2014;32(4_suppl):LBA1. [http://abstracts.asco.org/142/AbstView_142_123836.html link to original article] '''contains verified protocol''' --> | ||
− | # Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. [http://www.nejm.org/doi/full/10.1056/NEJMoa1405095 link to original article] [ | + | # Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. [http://www.nejm.org/doi/full/10.1056/NEJMoa1405095 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24881730 PubMed] |
==Prednisone {{#subobject:22 |Regimen=1}}== | ==Prednisone {{#subobject:22 |Regimen=1}}== | ||
Line 930: | Line 930: | ||
===References=== | ===References=== | ||
− | # de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. [http://www.nejm.org/doi/full/10.1056/NEJMoa1014618 link to original article] '''contains verified protocol''' [ | + | # de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. [http://www.nejm.org/doi/full/10.1056/NEJMoa1014618 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21612468 PubMed] |
− | ## '''Update:''' Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. Epub 2012 Sep 18. [http://www.sciencedirect.com/science/article/pii/S1470204512703790 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. Epub 2012 Sep 18. [http://www.sciencedirect.com/science/article/pii/S1470204512703790 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22995653 PubMed] |
− | ## '''Update:''' Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. Epub 2012 Nov 9. [http://www.sciencedirect.com/science/article/pii/S1470204512704734 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. Epub 2012 Nov 9. [http://www.sciencedirect.com/science/article/pii/S1470204512704734 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23142059 PubMed] |
− | # Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. Epub 2012 Dec 10. [http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 link to original article] '''contains verified protocol''' [ | + | # Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. Epub 2012 Dec 10. [http://www.nejm.org/doi/full/10.1056/NEJMoa1209096 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23228172 PubMed] |
=Chemotherapy for metastatic castrate-resistant disease= | =Chemotherapy for metastatic castrate-resistant disease= | ||
Line 973: | Line 973: | ||
===References=== | ===References=== | ||
− | # de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961389-X/fulltext link to original article] '''contains verified protocol''' [ | + | # de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961389-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20888992 PubMed] |
==Cabozantinib (Cometriq) {{#subobject:24 |Regimen=1}}== | ==Cabozantinib (Cometriq) {{#subobject:24 |Regimen=1}}== | ||
Line 993: | Line 993: | ||
===References=== | ===References=== | ||
− | # Smith DC, Smith MR, Sweeney C, Elfiky AA, Logothetis C, Corn PG, Vogelzang NJ, Small EJ, Harzstark AL, Gordon MS, Vaishampayan UN, Haas NB, Spira AI, Lara PN Jr, Lin CC, Srinivas S, Sella A, Schöffski P, Scheffold C, Weitzman AL, Hussain M. Cabozantinib in Patients With Advanced Prostate Cancer: Results of a Phase II Randomized Discontinuation Trial. J Clin Oncol. 2013 Feb 1;31(4):412-9. Epub 2012 Nov 19. [http://jco.ascopubs.org/content/31/4/412.full link to original article] '''contains verified protocol''' [ | + | # Smith DC, Smith MR, Sweeney C, Elfiky AA, Logothetis C, Corn PG, Vogelzang NJ, Small EJ, Harzstark AL, Gordon MS, Vaishampayan UN, Haas NB, Spira AI, Lara PN Jr, Lin CC, Srinivas S, Sella A, Schöffski P, Scheffold C, Weitzman AL, Hussain M. Cabozantinib in Patients With Advanced Prostate Cancer: Results of a Phase II Randomized Discontinuation Trial. J Clin Oncol. 2013 Feb 1;31(4):412-9. Epub 2012 Nov 19. [http://jco.ascopubs.org/content/31/4/412.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23169517 PubMed] |
==Carboplatin & Docetaxel {{#subobject:28 |Regimen=1}}== | ==Carboplatin & Docetaxel {{#subobject:28 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Ross RW, Beer TM, Jacobus S, Bubley GJ, Taplin ME, Ryan CW, Huang J, Oh WK; Prostate Cancer Clinical Trials Consortium. A phase 2 study of carboplatin plus docetaxel in men with metastatic hormone-refractory prostate cancer who are refractory to docetaxel. Cancer. 2008 Feb 1;112(3):521-6. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23195/full link to original article] '''contains verified protocol''' [ | + | # Ross RW, Beer TM, Jacobus S, Bubley GJ, Taplin ME, Ryan CW, Huang J, Oh WK; Prostate Cancer Clinical Trials Consortium. A phase 2 study of carboplatin plus docetaxel in men with metastatic hormone-refractory prostate cancer who are refractory to docetaxel. Cancer. 2008 Feb 1;112(3):521-6. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23195/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18085595 PubMed] |
− | # Nakabayashi M, Sartor O, Jacobus S, Regan MM, McKearn D, Ross RW, Kantoff PW, Taplin ME, Oh WK. Response to docetaxel/carboplatin-based chemotherapy as first- and second-line therapy in patients with metastatic hormone-refractory prostate cancer. BJU Int. 2008 Feb;101(3):308-12. [http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2007.07331.x/full link to original article] [ | + | # Nakabayashi M, Sartor O, Jacobus S, Regan MM, McKearn D, Ross RW, Kantoff PW, Taplin ME, Oh WK. Response to docetaxel/carboplatin-based chemotherapy as first- and second-line therapy in patients with metastatic hormone-refractory prostate cancer. BJU Int. 2008 Feb;101(3):308-12. [http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2007.07331.x/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18184327 PubMed] |
− | # Reuter CW, Morgan MA, Ivanyi P, Fenner M, Ganser A, Grünwald V. Carboplatin plus weekly docetaxel as salvage chemotherapy in docetaxel-resistant and castration-resistant prostate cancer. World J Urol. 2010 Jun;28(3):391-8. Epub 2010 Mar 14. [http://link.springer.com/article/10.1007%2Fs00345-010-0527-5 link to original article] '''contains verified protocol''' [ | + | # Reuter CW, Morgan MA, Ivanyi P, Fenner M, Ganser A, Grünwald V. Carboplatin plus weekly docetaxel as salvage chemotherapy in docetaxel-resistant and castration-resistant prostate cancer. World J Urol. 2010 Jun;28(3):391-8. Epub 2010 Mar 14. [http://link.springer.com/article/10.1007%2Fs00345-010-0527-5 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20229232 PubMed] |
==Carboplatin & Paclitaxel {{#subobject:30 |Regimen=1}}== | ==Carboplatin & Paclitaxel {{#subobject:30 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Jeske S, Tagawa ST, Olowokure O, Selzer J, Giannakakou P, Nanus DM. Carboplatin plus paclitaxel therapy after docetaxel in men with metastatic castrate resistant prostate cancer. Urol Oncol. 2011 Nov-Dec;29(6):676-81. Epub 2010 May 7. [http://www.urologiconcology.org/article/S1078-1439%2810%2900003-7/abstract link to original article] '''contains verified protocol''' [ | + | # Jeske S, Tagawa ST, Olowokure O, Selzer J, Giannakakou P, Nanus DM. Carboplatin plus paclitaxel therapy after docetaxel in men with metastatic castrate resistant prostate cancer. Urol Oncol. 2011 Nov-Dec;29(6):676-81. Epub 2010 May 7. [http://www.urologiconcology.org/article/S1078-1439%2810%2900003-7/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20451413 PubMed] |
− | # Kentepozidis N, Soultati A, Giassas S, Vardakis N, Kalykaki A, Kotsakis A, Papadimitraki E, Pantazopoulos N, Bozionellou V, Georgoulias V. Paclitaxel in combination with carboplatin as salvage treatment in patients with castration-resistant prostate cancer: a Hellenic oncology research group multicenter phase II study. Cancer Chemother Pharmacol. 2012 Jul;70(1):161-8. Epub 2012 Jun 3. [http://link.springer.com/article/10.1007%2Fs00280-012-1896-9 link to original article] '''contains verified protocol''' [ | + | # Kentepozidis N, Soultati A, Giassas S, Vardakis N, Kalykaki A, Kotsakis A, Papadimitraki E, Pantazopoulos N, Bozionellou V, Georgoulias V. Paclitaxel in combination with carboplatin as salvage treatment in patients with castration-resistant prostate cancer: a Hellenic oncology research group multicenter phase II study. Cancer Chemother Pharmacol. 2012 Jul;70(1):161-8. Epub 2012 Jun 3. [http://link.springer.com/article/10.1007%2Fs00280-012-1896-9 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22660737 PubMed] |
==CMF {{#subobject:25 |Regimen=1}}== | ==CMF {{#subobject:25 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Wozniak AJ, Blumenstein BA, Crawford ED, Boileau M, Rivkin SE, Fletcher WS. Cyclophosphamide, methotrexate, and 5-fluorouracil in the treatment of metastatic prostate cancer. A Southwest Oncology Group study. Cancer. 1993 Jun 15;71(12):3975-8. [http://onlinelibrary.wiley.com/doi/10.1002/1097-0142(19930615)71:12%3C3975::AID-CNCR2820711229%3E3.0.CO;2-D/abstract link to original article] '''contains verified protocol''' [ | + | # Wozniak AJ, Blumenstein BA, Crawford ED, Boileau M, Rivkin SE, Fletcher WS. Cyclophosphamide, methotrexate, and 5-fluorouracil in the treatment of metastatic prostate cancer. A Southwest Oncology Group study. Cancer. 1993 Jun 15;71(12):3975-8. [http://onlinelibrary.wiley.com/doi/10.1002/1097-0142(19930615)71:12%3C3975::AID-CNCR2820711229%3E3.0.CO;2-D/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8508363 PubMed] |
==CPD {{#subobject:26 |Regimen=1}}== | ==CPD {{#subobject:26 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Hellerstedt B, Pienta KJ, Redman BG, Esper P, Dunn R, Fardig J, Olson K, Smith DC. Phase II trial of oral cyclophosphamide, prednisone, and diethylstilbestrol for androgen-independent prostate carcinoma. Cancer. 2003 Oct 15;98(8):1603-10. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.11686/abstract link to original article] '''contains verified protocol''' [ | + | # Hellerstedt B, Pienta KJ, Redman BG, Esper P, Dunn R, Fardig J, Olson K, Smith DC. Phase II trial of oral cyclophosphamide, prednisone, and diethylstilbestrol for androgen-independent prostate carcinoma. Cancer. 2003 Oct 15;98(8):1603-10. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.11686/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14534875 PubMed] |
==Docetaxel & Prednisone {{#subobject:27 |Regimen=1}}== | ==Docetaxel & Prednisone {{#subobject:27 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. [http://www.nejm.org/doi/full/10.1056/NEJMoa040720 link to original article] '''contains verified protocol''' [ | + | # Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. [http://www.nejm.org/doi/full/10.1056/NEJMoa040720 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15470213 PubMed] |
− | ## '''Update:''' Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. [http://jco.ascopubs.org/content/26/2/242.full link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. [http://jco.ascopubs.org/content/26/2/242.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18182665 PubMed] |
− | # Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; for the PROSTY study group. 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. Epub 2013 Jan 4. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2812%2970537-5/abstract link to original article] '''contains verified protocol''' [ | + | # Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; for the PROSTY study group. 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. Epub 2013 Jan 4. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2812%2970537-5/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23294853 PubMed] |
==Mitoxantrone & Prednisone {{#subobject:29 |Regimen=1}}== | ==Mitoxantrone & Prednisone {{#subobject:29 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. [http://www.nejm.org/doi/full/10.1056/NEJMoa040720 link to original article] '''contains verified protocol''' [ | + | # Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. [http://www.nejm.org/doi/full/10.1056/NEJMoa040720 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15470213 PubMed] |
− | ## '''Update:''' Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. [http://jco.ascopubs.org/content/26/2/242.full link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. [http://jco.ascopubs.org/content/26/2/242.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18182665 PubMed] |
− | # Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. [http://www.nejm.org/doi/full/10.1056/NEJMoa041318 link to original article] [ | + | # Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. [http://www.nejm.org/doi/full/10.1056/NEJMoa041318 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15470214 PubMed] |
− | # de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961389-X/fulltext link to original article] '''contains verified protocol''' [ | + | # de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961389-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20888992 PubMed] |
==Olaparib (Lynparza) {{#subobject:defe72|Regimen=1}}== | ==Olaparib (Lynparza) {{#subobject:defe72|Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Slovin SF, Higano CS, Hamid O, Tejwani S, Harzstark A, Alumkal JJ, Scher HI, Chin K, Gagnier P, McHenry MB, Beer TM. Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study. Ann Oncol. 2013 Jul;24(7):1813-21. [http://annonc.oxfordjournals.org/content/24/7/1813.long link to original article] '''contains verified protocol''' [ | + | # Slovin SF, Higano CS, Hamid O, Tejwani S, Harzstark A, Alumkal JJ, Scher HI, Chin K, Gagnier P, McHenry MB, Beer TM. Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study. Ann Oncol. 2013 Jul;24(7):1813-21. [http://annonc.oxfordjournals.org/content/24/7/1813.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23535954 PubMed] |
==Placebo== | ==Placebo== | ||
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===References=== | ===References=== | ||
− | # Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. [http://www.nejm.org/doi/full/10.1056/NEJMoa1001294 link to original article] '''contains verified protocol''' [ | + | # Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. [http://www.nejm.org/doi/full/10.1056/NEJMoa1001294 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20818862 PubMed] |
==Sipuleucel-T (Provenge) {{#subobject:32 |Regimen=1}}== | ==Sipuleucel-T (Provenge) {{#subobject:32 |Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. [http://www.nejm.org/doi/full/10.1056/NEJMoa1001294 link to original article] '''contains verified protocol''' [ | + | # Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. [http://www.nejm.org/doi/full/10.1056/NEJMoa1001294 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20818862 PubMed] |
− | # '''Safety analysis:''' Hall SJ, Klotz L, Pantuck AJ, George DJ, Whitmore JB, Frohlich MW, Sims RB. Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. J Urol. 2011 Sep;186(3):877-81. Epub 2011 Jul 23. [http://www.sciencedirect.com/science/article/pii/S0022534711038511 link to original article] '''contains verified protocol''' [ | + | # '''Safety analysis:''' Hall SJ, Klotz L, Pantuck AJ, George DJ, Whitmore JB, Frohlich MW, Sims RB. Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. J Urol. 2011 Sep;186(3):877-81. Epub 2011 Jul 23. [http://www.sciencedirect.com/science/article/pii/S0022534711038511 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21788048 PubMed] |
# [http://www.dendreon.com/prescribing-information.pdf Sipuleucel-T (Provenge) package insert] | # [http://www.dendreon.com/prescribing-information.pdf Sipuleucel-T (Provenge) package insert] | ||
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===References=== | ===References=== | ||
− | # Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. [http://www.sciencedirect.com/science/article/pii/S147020450770147X link to original article] '''contains verified protocol''' [ | + | # Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. [http://www.sciencedirect.com/science/article/pii/S147020450770147X link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17544845 PubMed] |
− | ## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed] |
<!-- | <!-- | ||
# Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session] | # Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session] | ||
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# Nicholas J. Vogelzang, Chris Parker, Sten Nilsson, Robert Edward Coleman, C. Gillies O'Bryan-Tear, Minghua Shan, A. Oliver Sartor. Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA). 2013 ASCO Genitourinary Cancers Symposium Abstract 11. [https://meetinglibrary.asco.org/content/107117-134 link to abstract] | # Nicholas J. Vogelzang, Chris Parker, Sten Nilsson, Robert Edward Coleman, C. Gillies O'Bryan-Tear, Minghua Shan, A. Oliver Sartor. Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA). 2013 ASCO Genitourinary Cancers Symposium Abstract 11. [https://meetinglibrary.asco.org/content/107117-134 link to abstract] | ||
# Sten Nilsson, A. Oliver Sartor, Oyvind S. Bruland, Fang Fang, Anne-Kirsti Aksnes, Chris Parker. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. 2013 ASCO Genitourinary Cancers Symposium Abstract 19. [http://meetinglibrary.asco.org/content/107297-134 link to abstract] | # Sten Nilsson, A. Oliver Sartor, Oyvind S. Bruland, Fang Fang, Anne-Kirsti Aksnes, Chris Parker. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. 2013 ASCO Genitourinary Cancers Symposium Abstract 19. [http://meetinglibrary.asco.org/content/107297-134 link to abstract] | ||
− | # '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [ | + | # '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed] |
--> | --> | ||
− | # Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. [http://www.nejm.org/doi/full/10.1056/NEJMoa1213755 link to original article] '''contains verified protocol''' [ | + | # Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. [http://www.nejm.org/doi/full/10.1056/NEJMoa1213755 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23863050 PubMed] |
## '''Subgroup analysis:''' Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2814%2970474-7/abstract link to original article] | ## '''Subgroup analysis:''' Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2814%2970474-7/abstract link to original article] | ||
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===References=== | ===References=== | ||
− | # Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. [http://www.sciencedirect.com/science/article/pii/S147020450770147X link to original article] '''contains verified protocol''' [ | + | # Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. [http://www.sciencedirect.com/science/article/pii/S147020450770147X link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17544845 PubMed] |
− | ## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [ | + | ## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed] |
<!-- | <!-- | ||
# Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session] | # Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session] | ||
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# Nicholas J. Vogelzang, Chris Parker, Sten Nilsson, Robert Edward Coleman, C. Gillies O'Bryan-Tear, Minghua Shan, A. Oliver Sartor. Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA). 2013 ASCO Genitourinary Cancers Symposium Abstract 11. [https://meetinglibrary.asco.org/content/107117-134 link to abstract] | # Nicholas J. Vogelzang, Chris Parker, Sten Nilsson, Robert Edward Coleman, C. Gillies O'Bryan-Tear, Minghua Shan, A. Oliver Sartor. Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA). 2013 ASCO Genitourinary Cancers Symposium Abstract 11. [https://meetinglibrary.asco.org/content/107117-134 link to abstract] | ||
# Sten Nilsson, A. Oliver Sartor, Oyvind S. Bruland, Fang Fang, Anne-Kirsti Aksnes, Chris Parker. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. 2013 ASCO Genitourinary Cancers Symposium Abstract 19. [http://meetinglibrary.asco.org/content/107297-134 link to abstract] | # Sten Nilsson, A. Oliver Sartor, Oyvind S. Bruland, Fang Fang, Anne-Kirsti Aksnes, Chris Parker. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. 2013 ASCO Genitourinary Cancers Symposium Abstract 19. [http://meetinglibrary.asco.org/content/107297-134 link to abstract] | ||
− | # '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [ | + | # '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.sciencedirect.com/science/article/pii/S1558767312001681 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed] |
--> | --> | ||
− | # Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. [http://www.nejm.org/doi/full/10.1056/NEJMoa1213755 link to original article] '''contains verified protocol''' [ | + | # Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. [http://www.nejm.org/doi/full/10.1056/NEJMoa1213755 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23863050 PubMed] |
## '''Subgroup analysis:''' Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2814%2970474-7/abstract link to original article] | ## '''Subgroup analysis:''' Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2814%2970474-7/abstract link to original article] | ||
Line 1,540: | Line 1,540: | ||
===References=== | ===References=== | ||
− | # Resche I, Chatal JF, Pecking A, Ell P, Duchesne G, Rubens R, Fogelman I, Houston S, Fauser A, Fischer M, Wilkins D. A dose-controlled study of 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP) in the treatment of patients with painful bone metastases. Eur J Cancer. 1997 Sep;33(10):1583-91. [http://www.sciencedirect.com/science/article/pii/S095980499700155X link to original article] '''contains verified protocol''' [ | + | # Resche I, Chatal JF, Pecking A, Ell P, Duchesne G, Rubens R, Fogelman I, Houston S, Fauser A, Fischer M, Wilkins D. A dose-controlled study of 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP) in the treatment of patients with painful bone metastases. Eur J Cancer. 1997 Sep;33(10):1583-91. [http://www.sciencedirect.com/science/article/pii/S095980499700155X link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9389919 PubMed] |
− | # Sartor O, Reid RH, Hoskin PJ, Quick DP, Ell PJ, Coleman RE, Kotler JA, Freeman LM, Olivier P; Quadramet 424Sm10/11 Study Group. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology. 2004 May;63(5):940-5. [http://www.goldjournal.net/article/S0090-4295%2804%2900143-8/abstract link to original article] '''contains verified protocol''' [ | + | # Sartor O, Reid RH, Hoskin PJ, Quick DP, Ell PJ, Coleman RE, Kotler JA, Freeman LM, Olivier P; Quadramet 424Sm10/11 Study Group. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology. 2004 May;63(5):940-5. [http://www.goldjournal.net/article/S0090-4295%2804%2900143-8/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15134985 PubMed] |
=Measuring disease progression= | =Measuring disease progression= | ||
− | *Criteria used for disease progression in prostate cancer clinical trials, Prostate Cancer Clinical Trials Working Group 2 (PCWG2):<ref>Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. [http://jco.ascopubs.org/content/26/7/1148.long link to original article] [ | + | *Criteria used for disease progression in prostate cancer clinical trials, Prostate Cancer Clinical Trials Working Group 2 (PCWG2):<ref>Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. [http://jco.ascopubs.org/content/26/7/1148.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18309951 PubMed]</ref> |
**Castrate level of serum testosterone is <50 ng/dL (<1.7 nmol/L) | **Castrate level of serum testosterone is <50 ng/dL (<1.7 nmol/L) | ||
− | ***However, there is controversy/disagreement in other references about whether a lower level should be used, such as <20 ng/dL (0.7 nmol/L)<ref>Oefelein MG, Feng A, Scolieri MJ, Ricchiutti D, Resnick MI. Reassessment of the definition of castrate levels of testosterone: implications for clinical decision making. Urology. 2000 Dec 20;56(6):1021-4. [http://www.goldjournal.net/article/S0090-4295%2800%2900793-7/abstract link to original article] [ | + | ***However, there is controversy/disagreement in other references about whether a lower level should be used, such as <20 ng/dL (0.7 nmol/L)<ref>Oefelein MG, Feng A, Scolieri MJ, Ricchiutti D, Resnick MI. Reassessment of the definition of castrate levels of testosterone: implications for clinical decision making. Urology. 2000 Dec 20;56(6):1021-4. [http://www.goldjournal.net/article/S0090-4295%2800%2900793-7/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11113751 PubMed]</ref> |
**PSA rise | **PSA rise | ||
***Starting PSA of at least 2.0 ng/mL | ***Starting PSA of at least 2.0 ng/mL | ||
Line 1,568: | Line 1,568: | ||
=Statistics= | =Statistics= | ||
− | *[http://jama.jamanetwork.com/article.aspx?articleid=198392 Four-Year Actuarial Progression-Free Probability (PFP) After Salvage Radiotherapy based on Gleason score, PSA, positive margins, etc.]<ref>Stephenson AJ, Shariat SF, Zelefsky MJ, Kattan MW, Butler EB, Teh BS, Klein EA, Kupelian PA, Roehrborn CG, Pistenmaa DA, Pacholke HD, Liauw SL, Katz MS, Leibel SA, Scardino PT, Slawin KM. Salvage Radiotherapy for Recurrent Prostate Cancer After Radical Prostatectomy. JAMA. 2004 Mar 17;291(11):1325-32. [http://jama.jamanetwork.com/article.aspx?articleid=198392 link to original article] [ | + | *[http://jama.jamanetwork.com/article.aspx?articleid=198392 Four-Year Actuarial Progression-Free Probability (PFP) After Salvage Radiotherapy based on Gleason score, PSA, positive margins, etc.]<ref>Stephenson AJ, Shariat SF, Zelefsky MJ, Kattan MW, Butler EB, Teh BS, Klein EA, Kupelian PA, Roehrborn CG, Pistenmaa DA, Pacholke HD, Liauw SL, Katz MS, Leibel SA, Scardino PT, Slawin KM. Salvage Radiotherapy for Recurrent Prostate Cancer After Radical Prostatectomy. JAMA. 2004 Mar 17;291(11):1325-32. [http://jama.jamanetwork.com/article.aspx?articleid=198392 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15026399 PubMed]</ref> (flowchart is in Figure 2) |
*[http://seer.cancer.gov/statfacts/html/prost.html SEER Stat Fact Sheets: Prostate Cancer] | *[http://seer.cancer.gov/statfacts/html/prost.html SEER Stat Fact Sheets: Prostate Cancer] | ||
*[http://www.cdc.gov/CANCER/prostate/statistics/ CDC Prostate Cancer Statistics] | *[http://www.cdc.gov/CANCER/prostate/statistics/ CDC Prostate Cancer Statistics] |
Revision as of 02:16, 2 December 2016
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Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.
80 regimens on this page
112 variants on this page
|
Androgen deprivation therapy (ADT) & radiation therapy
Goserelin & RT
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RT: Radiation Therapy
Regimen
Study | Evidence | Comparator |
Pilepich et al. 2005 (RTOG 85-31) | Phase III | RT |
Bolla et al. 1997 | Phase III | RT |
Endocrine & Radiotherapy
- Goserelin (Zoladex) 3.6 mg SC once every 4 weeks, to start during the last week of radiation therapy and to continue indefinitely or until progression
- Radiation therapy, 1.8 to 2 Gy per fraction, with an initial 44 to 46 Gy to the pelvis, then an additional boost to the prostate that resulted in a total dose of 65 to 70 Gy in definitive radiation patients; 60 to 65 Gy total dose for post-prostatectomy patients
References
- Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. link to original article contains protocol PubMed
- Update: Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. link to original article contains protocol PubMed
- Update: Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. link to original article contains verified protocol PubMed
- Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. link to original article PubMed
Goserelin, Flutamide, RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator |
Pilepich et al. 2001 (RTOG 86-10) | Phase III | RT |
Hanks et al. 2003 (RTOG 92-02) | Non-randomized | |
Denham et al. 2005 (TTROG 96.01) | Phase III | RT |
D'Amico et al. 2008 | Phase III | RT |
Jones et al. 2011 | Phase III | Leuprolide, Flutamide, RT RT |
Endocrine & Radiotherapy
- Goserelin (Zoladex) 3.6 mg SC once every 4 weeks, to start 2 months prior to radiation therapy and to continue at least through the end of radiation therapy
- Flutamide (Eulexin) 250 mg PO three times per day, to start 2 months prior to radiation therapy and to continue at least through the end of radiation therapy
- Radiation therapy is started 2 months after start of androgen deprivation therapy (ADT), 1.8 to 2 Gy per fraction, with an initial 44 to 46 Gy to the pelvis, then an additional conedown to the prostate that resulted in a total dose of 65 to 70 Gy
Patients in RTOG 92-02 were subsequently randomized to adjuvant goserelin x 2 years versus no further treatment.
References
- Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. link to original article contains verified protocol PubMed
- Update: Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. link to original article contains verified protocol PubMed
- Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. link to original article contains protocol PubMed
- Update: Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. link to original article contains verified protocol PubMed
- Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. link to original article contains protocol PubMed
- D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. link to original article PubMed content property of HemOnc.org
- Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. link to original article contains verified protocol PubMed
Leuprolide, Flutamide, RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator |
Jones et al. 2011 | Phase III | Goserelin, Flutatmide, RT RT |
Endocrine & Radiotherapy
- Leuprolide (Lupron) 7.5 mg SC once every 4 weeks x 4 months, to start 2 months prior to radiation therapy
- Flutamide (Eulexin) 250 mg PO three times per day x 4 months, to start 2 months prior to radiation therapy
- Radiation therapy is started 2 months after start of androgen deprivation therapy (ADT), 1.8 to 2 Gy per fraction, with an initial 44 to 46 Gy to the pelvis, then an additional conedown to the prostate that resulted in a total dose of 65 to 70 Gy
References
- Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. link to original article contains verified protocol PubMed
RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator |
Pilepich et al. 1997 (RTOG 85-31) | Phase III | Goserelin & RT |
Bolla et al. 1997 | Phase III | Goserelin & RT |
Pilepich et al. 2001 (RTOG 86-10) | Phase III | Goserelin, Flutatmide, RT |
Denham et al. 2005 (TTROG 96.01) | Phase III | Goserelin & Flutatmide x 3m, RT Goserelin & Flutatmide x 6m, RT |
D'Amico et al. 2008 | Phase III | Goserelin, Flutatmide, RT |
Jones et al. 2011 | Phase III | Goserelin, Flutatmide, RT Leuprolide, Flutamide, RT |
Demonstrated to be inferior; here for reference purposes only.
References
- Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. link to original article contains protocol PubMed
- Update: Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. link to original article contains protocol PubMed
- Update: Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. link to original article contains verified protocol PubMed
- Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. link to original article PubMed
- Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. link to original article contains verified protocol PubMed
- Update: Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. link to original article contains verified protocol PubMed
- Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. link to original article contains protocol PubMed
- D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. link to original article PubMed content property of HemOnc.org
- Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. link to original article contains verified protocol PubMed
Hormonal therapy, adjuvant
Goserelin (Zoladex)
back to top |
Regimen
Study | Evidence | Comparator |
Hanks et al. 2003 (RTOG 92-02) | Phase III | No further treatment |
Treatment preceded by goserelin, flutamide, RT.
Endocrine therapy
- Goserelin (Zoladex) 3.6 mg SC once per month
2-year course
References
- Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. link to original article contains protocol PubMed
- Update: Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. link to original article contains verified protocol PubMed
Observation
back to top |
Regimen
Study | Evidence | Comparator |
Hanks et al. 2003 (RTOG 92-02) | Phase III | Goserelin |
Preceded by goserelin, flutamide, RT. No further treatment.
References
- Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. link to original article contains protocol PubMed
- Update: Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. link to original article contains verified protocol PubMed
Hormonal therapy, metastatic or locally advanced disease
Androgen Deprivation Therapy (ADT) & Docetaxel
Regimen
Study | Evidence | Comparator |
Sweeney et al. 2015 (ECOG E3805) | Randomized Controlled Study | Leuprolide |
Patients already on androgen deprivation therapy were eligible to participate in ECOG E3805 if there was no evidence of disease progression and if they had started ADT no more than 120 days before randomization.
Chemohormonal therapy
- Docetaxel (Taxotere) 75 mg/m2 IV over 1 hour once on day 1
- ADT - LHRH agonist or antagonist or surgical castration. Intermittent hormonal therapy was not allowed. Antiandrogens e.g. bicalutamide were allowed at the start of therapy "at the discretion of the investigator."
Supportive medications
- Dexamethasone (Decadron) 8 mg by mouth given three times; 12 hours, 3 hours, and 1 hour before Docetaxel (Taxotere)
- Daily prednisone was not required
- At least calcium 500 mg and vitamin D 400 IU per day
21-day cycle for up to 6 cycles
References
- Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. Epub 2015 Aug 5. link to original article contains verified protocol Pubmed
Bicalutamide (Casodex)
back to top |
Regimen
Study | Evidence | Comparator |
Tyrrell et al. 1998 | Phase III | Castration |
Not approved for monotherapy in the United States. See combination regimens with Goserelin & Leuprolide.
Endocrine therapy
- Bicalutamide (Casodex) 150 mg PO once per day
References
- Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. contains protocol PubMed
- Update: Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. link to original article contains verified protocol PubMed
Bicalutamide & Goserelin
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Regimen #1
Study | Evidence | Comparator |
Akaza et al. 2004 | Phase III | Leuprolide |
Endocrine therapy
- Bicalutamide (Casodex) 80 mg PO once per day
- Goserelin (Zoladex) 3.6 mg SC once every 4 weeks
Regimen #2
Study | Evidence | Comparator |
Schellhammer et al. 1995 (CASODEX Combination Study Group) | Phase III | Bicalutamide & Leuprolide Flutamide & Goserelin Flutamide & Leuprolide |
Endocrine therapy
- Bicalutamide (Casodex) 50 mg PO once per day
- Goserelin (Zoladex) 3.6 mg SC once every 4 weeks
References
- Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. link to original article PubMed
- Update: Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. link to original article contains protocol PubMed
- Update: Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. contains protocol PubMed
- Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. link to original article contains verified protocol PubMed
Bicalutamide & Leuprolide
back to top |
Regimen #1
Study | Evidence | Comparator |
Akaza et al. 2004 | Phase III | Leuprolide |
Endocrine therapy
- Bicalutamide (Casodex) 80 mg PO once per day
- Leuprolide (Lupron) 1-month depot 3.75 mg SC once every 4 weeks
Regimen #2
Study | Evidence | Comparator |
Schellhammer et al. 1995 (CASODEX Combination Study Group) | Phase III | Bicalutamide & Goserelin Flutamide & Goserelin Flutamide & Leuprolide |
Endocrine therapy
- Bicalutamide (Casodex) 50 mg PO once per day
- Leuprolide (Lupron) 1-month depot 7.5 mg IM once every 4 weeks
References
- Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. link to original article PubMed
- Update: Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. link to original article contains protocol PubMed
- Update: Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. contains protocol PubMed
- Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. link to original article contains verified protocol PubMed
Castration
back to top |
Regimen
Study | Evidence | Comparator |
Soloway et al. 1991 (Zoladex Prostate Study Group) | Phase III | Goserelin |
Kaisary et al. 1991 | Phase III | Goserelin |
Janknegt et al. 1993 (International Anandron Study Group) | Phase III | Nilutamide & Orchiectomy |
Denis et al. 1993 (EORTC 30853) | Phase III | Flutamide & Goserelin |
Boccon-Gibod et al. 1997 | Phase III | Flutamide |
Tyrrell et al. 1998 | Phase III | Bicalutamide |
Not widely used as monotherapy in the United States; included for reference purposes only.
References
- Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. PubMed
- Update: Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. link to original article contains verified protocol PubMed
- Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. PubMed
- Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. PubMed
- Update: Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. PubMed
- Update: Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. PubMed
- Update: de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. link to original article contains verified protocol PubMed
- Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. contains protocol PubMed
- Update: Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. PubMed
- Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5; discussion 395-6. contains protocol PubMed
- Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. contains protocol PubMed
- Update: Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. link to original article contains verified protocol PubMed
Degarelix (Firmagon)
Example orders
back to top |
Regimen #1, 240/80
Study | Evidence | Comparator |
Klotz et al. 2008 (CS21) | Phase III | Degarelix 240/160 Leuprolide |
This is the recommended dose in package insert.
Endocrine therapy
- Degarelix (Firmagon) 240 mg (given as 2 x 120 mg injections) SC once, then 80 mg SC once every 28 days
Regimen #2, 240/160
Study | Evidence | Comparator |
Klotz et al. 2008 (CS21) | Phase III | Degarelix 240/80 Leuprolide |
Endocrine therapy
- Degarelix (Firmagon) 240 mg (given as 2 x 120 mg injections) SC once, then 160 mg SC once every 28 days
References
- Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. link to original article contains verified protocol PubMed
- Update: Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Crawford ED, Moul J, Jensen JK, Kold Olesen T, Persson BE. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010 May;57(5):836-42. Epub 2009 Nov 20. link to original article contains verified protocol PubMed
Flutamide (Eulexin)
back to top |
Regimen
Study | Evidence | Comparator |
Boccon-Gibod et al. 1997 | Phase III | Orchiectomy |
Not approved for monotherapy in the United States. See combination regimens with Goserelin & Leuprolide.
Endocrine therapy
- Flutamide (Eulexin) 250 mg PO three times per day
References
- Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5; discussion 395-6. contains protocol PubMed
Flutamide & Goserelin
back to top |
Regimen
Endocrine therapy
- Flutamide (Eulexin) 250 mg PO three times per day
- Goserelin (Zoladex) 3.6 mg SC once every 4 weeks
References
- Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. contains protocol PubMed
- Update: Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. PubMed
- Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. link to original article PubMed
- Update: Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. link to original article contains protocol PubMed
- Update: Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. contains protocol PubMed
Flutamide & Leuprolide
back to top |
Regimen
Study | Evidence | Comparator |
Schellhammer et al. 1995 (CASODEX Combination Study Group) | Phase III | Bicalutamide & Goserelin Bicalutamide & Leuprolide Flutamide & Goserelin |
Endocrine therapy
- Flutamide (Eulexin) 250 mg PO three times per day
- Leuprolide (Lupron) 1-month depot 7.5 mg IM once every 4 weeks
References
- Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group. Urology. 1995 May;45(5):745-52. link to original article PubMed
- Update: Schellhammer PF, Sharifi R, Block NL, Soloway MS, Venner PM, Patterson AL, Sarosdy MF, Vogelzang NJ, Chen Y, Kolvenbag GJ. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate carcinoma. Analysis of time to progression. CASODEX Combination Study Group. Cancer. 1996 Nov 15;78(10):2164-9. link to original article contains protocol PubMed
- Update: Soloway MS, Schellhammer P, Sharifi R, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G. A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group. Eur Urol. 1996;29 Suppl 2:105-9. contains protocol PubMed
Goserelin (Zoladex)
Example orders
back to top |
Regimen
Study | Evidence | Comparator |
Soloway et al. 1991 (Zoladex Prostate Study Group) | Phase III | Bilateral orchiectomy |
Kaisary et al. 1991 | Phase III | Bilateral orchiectomy |
Endocrine therapy
- Goserelin (Zoladex) 3.6 mg SC once every 4 weeks
References
- Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. PubMed
- Update: Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. link to original article contains verified protocol PubMed
- Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. PubMed
Leuprolide (Lupron)
Example orders
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Regimen #1, 1-month depot, 3.75 mg
Study | Evidence | Comparator |
Akaza et al. 2004 | Phase III | Bicalutamide & Goserelin Bicalutamide & Leuprolide |
Endocrine therapy
- Leuprolide (Lupron) 1-month depot 3.75 mg SC once every 4 weeks
Regimen #2, 1-month depot, 7.5 mg
Study | Evidence | Comparator |
Klotz et al. 2008 (CS21) | Phase III | Degarelix 240/80 Degarelix 240/160 |
Endocrine therapy
- Leuprolide (Lupron) 1-month depot 7.5 mg IM once every 4 weeks
Regimen #3, 3-month depot
Study | Evidence |
Sharifi et al. 1996 | Phase II |
Endocrine therapy
- Leuprolide (Lupron) 3-month depot 22.5 mg IM once every 12 weeks
Regimen #4, 4-month depot
Study | Evidence |
Sharifi et al. 1998 | Phase II |
Endocrine therapy
- Leuprolide (Lupron) 4-month depot 30 mg IM once every 16 weeks
Other
- One of the following:
- Leuprolide (Lupron) 6-month depot 45 mg IM once every 24 weeks
- Leuprolide (Lupron) 4-month depot 30 mg IM once every 16 weeks
- Leuprolide (Lupron) 3-month depot 22.5 mg IM once every 12 weeks
- Leuprolide (Lupron) 1-month depot 7.5 mg IM once every 4 weeks
Supportive medications (varies depending on reference):
- Bicalutamide (Casodex) 50 mg PO once per day for protection from testosterone flare
References
- Sharifi R, Bruskewitz RC, Gittleman MC, Graham SD Jr, Hudson PB, Stein B. Leuprolide acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer. Clin Ther. 1996 Jul-Aug;18(4):647-57. link to original article contains verified protocol PubMed
- Sharifi R, Knoll LD, Smith J, Kramolowsky E. Leuprolide acetate (30-mg depot every four months) in the treatment of advanced prostate cancer. Urology. 1998 Feb;51(2):271-6. link to original article PubMed
- Akaza H, Yamaguchi A, Matsuda T, Igawa M, Kumon H, Soeda A, Arai Y, Usami M, Naito S, Kanetake H, Ohashi Y. Superior anti-tumor efficacy of bicalutamide 80 mg in combination with a luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist monotherapy as first-line treatment for advanced prostate cancer: interim results of a randomized study in Japanese patients. Jpn J Clin Oncol. 2004 Jan;34(1):20-8. link to original article contains verified protocol PubMed
- Loblaw DA, Virgo KS, Nam R, Somerfield MR, Ben-Josef E, Mendelson DS, Middleton R, Sharp SA, Smith TJ, Talcott J, Taplin M, Vogelzang NJ, Wade JL 3rd, Bennett CL, Scher HI; American Society of Clinical Oncology. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007 Apr 20;25(12):1596-605. Epub 2007 Apr 2. link to original article PubMed
- Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. link to original article contains verified protocol PubMed
- Update: Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Crawford ED, Moul J, Jensen JK, Kold Olesen T, Persson BE. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol. 2010 May;57(5):836-42. Epub 2009 Nov 20. link to original article contains verified protocol PubMed
- Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. Epub 2015 Aug 5. link to original article contains verified protocol Pubmed
Nilutamide & Orchiectomy
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Regimen
Study | Evidence | Comparator |
Janknegt et al. 1993 (International Anandron Study Group) | Phase III | Orchiectomy |
Nilutamide to start the day of, or day after surgical castration/orchiectomy.
Endocrine therapy
- Nilutamide (Nilandron) 300 mg PO once per day x 1 month, then 150 mg PO once per day
References
- Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. PubMed
- Update: Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. PubMed
- Update: Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. PubMed
- Update: de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. link to original article contains verified protocol PubMed
- Nilutamide (Nilandron) package insert
Second-line hormonal therapy
Abiraterone & Prednisone
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Regimen
Study | Evidence | ORR, PSA RR | Comparator | Comparator ORR, PSA RR | Pt Population |
de Bono et al. 2011 (COU-AA-301) | Phase III | 14% (95% CI n/a), 29% | Prednisone | 3% (95% CI n/a), 6% | Chemo-exposed |
Ryan et al. 2013 (COU-AA-302) | Phase III | 36% (95% CI n/a), 62% | Prednisone | 16% (95% CI n/a), 24% | Chemo-naive |
Endocrine therapy
- Abiraterone (Zytiga) 1000 mg PO once per day, 1 hour before or 2 hours after meals
- Prednisone (Sterapred) 5 mg PO BID
References
- de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. link to original article contains verified protocol PubMed
- Update: Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. Epub 2012 Sep 18. link to original article contains verified protocol PubMed
- Update: Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. Epub 2012 Nov 9. link to original article contains verified protocol PubMed
- Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. Epub 2012 Dec 10. link to original article contains verified protocol PubMed
Antiandrogen withdrawal
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Regimen
Study | Evidence | Comparator |
Small et al. 2004 (CALGB 9583) | Phase III | Ketoconazole & Hydrocortisone |
Refers to cessation of antiandrogen therapy.
References
- Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, Gable P, Torti FM, Kaplan E, Vogelzang NJ. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol. 2004 Mar 15;22(6):1025-33. link to original article contains verified protocol PubMed
Bicalutamide (Casodex)
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Regimen
Study | Evidence | ORR, PSA RR | Comparator | Comparator ORR, PSA RR | Pt Population |
Penson et al. 2016 (STRIVE) | Phase II | pts w/ measurable disease: 14% (95% CI n/a), 31% (95% CI n/a) | Enzalutamide | pts w/ measurable disease: 60% (95% CI n/a), 81% (95% CI n/a) | Chemo-naive, abi and keto-naive |
Patients continued ADT while on study; details not provided.
Endocrine therapy
- Bicalutamide (Casodex) 50 mg PO once per day
Continued until progression
References
- Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. Epub 2016 Jan 25. link to original article contains protocol PubMed
Enzalutamide (Xtandi)
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Regimen
Study | Evidence | ORR, PSA RR | Comparator | Comparator ORR, PSA RR | Pt Population |
Scher et al. 2012 (AFFIRM) | Phase III | 29% (95% CI n/a), 54% | Placebo | 4% (95% CI n/a), 2% | Chemo-exposed (docetaxel) |
Beer et al. 2014 (PREVAIL) | Phase III | 59% (95% CI n/a), 78% | Placebo | 5% (95% CI n/a), 3% | Chemo and abiraterone naive |
Penson et al. 2016 (STRIVE) | Phase II | 60% (95% CI n/a), 81% | Bicalutamide | 14% (95% CI n/a), 31% | Chemo and bicalutamide naive |
Patients in STRIVE continued ADT while on study; details not provided.
Endocrine therapy
- Enzalutamide (Xtandi) 160 mg PO once per day
Continued until progression
References
- Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. link to original article contains verified protocol PubMed
- Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. link to original article PubMed
- Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. Epub 2016 Jan 25. link to original article contains protocol PubMed
Ketoconazole & Hydrocortisone
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Regimen
Study | Evidence | ORR, PSA RR | Comparator | Comparator ORR, PSA RR | Pt Population |
Small et al. 2004 (CALGB 9583) | Phase III | pts w/ measurable disease: 20% (95% CI 11 - 32), 27% (95% CI 20 - 35) | Antiandrogen withdrawal | pts w/ measurable disease: 2% (95% CI 0 - 11), 11% (95% CI 7 - 17) | Progression at ADT, i.e. CRPC |
Endocrine therapy
- Ketoconazole (Nizoral) 400 mg PO three times per day
- Hydrocortisone (Cortef) 30 mg PO QAM and 10 mg PO QPM
References
- Small EJ, Halabi S, Dawson NA, Stadler WM, Rini BI, Picus J, Gable P, Torti FM, Kaplan E, Vogelzang NJ. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: a phase III trial (CALGB 9583). J Clin Oncol. 2004 Mar 15;22(6):1025-33. link to original article contains verified protocol PubMed
Ketoconazole, Hydrocortisone, Dutasteride
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Regimen
Study | Evidence |
Taplin et al. 2009 | Phase II |
Endocrine therapy
- Ketoconazole (Nizoral) 400 mg PO three times per day
- Hydrocortisone (Cortef) 30 mg PO QAM and 10 mg PO QPM
- Dutasteride (Avodart) 0.5 mg PO once per day
References
- Taplin ME, Regan MM, Ko YJ, Bubley GJ, Duggan SE, Werner L, Beer TM, Ryan CW, Mathew P, Tu SM, Denmeade SR, Oh WK, Sartor O, Mantzoros CS, Rittmaster R, Kantoff PW, Balk SP. Phase II study of androgen synthesis inhibition with ketoconazole, hydrocortisone, and dutasteride in asymptomatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Nov 15;15(22):7099-105. Epub 2009 Nov 3. link to original article contains verified protocol PubMed
Placebo
back to top |
Regimen
Study | Evidence | Comparator |
Scher et al. 2012 (AFFIRM) | Phase III | Enzalutamide |
Beer et al. 2014 (PREVAIL) | Phase III | Enzalutamide |
No active antineoplastic treatment; this was the comparator arm in at least one randomized trial and is included for reference purposes, only.
References
- Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. link to original article contains verified protocol PubMed
- Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. link to original article PubMed
Prednisone
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Regimen
Study | Evidence | Comparator |
de Bono et al. 2011 (COU-AA-301) | Phase III | Abiraterone & Prednisone |
Ryan et al. 2013 (COU-AA-302) | Phase III | Abiraterone & Prednisone |
Not used as monotherapy in routine practice; this was the comparator arm in at least one randomized trial and is included for reference purposes, only.
References
- de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. link to original article contains verified protocol PubMed
- Update: Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. Epub 2012 Sep 18. link to original article contains verified protocol PubMed
- Update: Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. Epub 2012 Nov 9. link to original article contains verified protocol PubMed
- Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. Epub 2012 Dec 10. link to original article contains verified protocol PubMed
Chemotherapy for metastatic castrate-resistant disease
Cabazitaxel & Prednisone
Example orders
back to top |
Regimen
Study | Evidence | ORR, PSA RR | Comparator | Comparator ORR, PSA RR | Pt Population |
de Bono et al. 2010 (TROPIC) | Phase III | pts w/ measurable disease: 14.4% (95% CI 9.6 - 19.3), 39.2% (95% CI 33.9 - 44.5) | Mitoxantrone & Prednisone | pts w/ measurable disease: 4.4% (95% CI 1.6 - 7.2), 17.8% (95% CI 13.7 - 22.0) | Progressed on docetaxel |
Chemotherapy
- Cabazitaxel (Jevtana) 25 mg/m2 IV over 1 hour once on day 1
- Prednisone (Sterapred) 10 mg PO once per day on days 1 to 21
Supportive medications
- Antihistamine given at least 30 minutes before Cabazitaxel (Jevtana)
- Corticosteroid (dexamethasone 8 mg or equivalent) given at least 30 minutes before Cabazitaxel (Jevtana)
- Histamine H2-antagonist (except cimetidine) given at least 30 minutes before Cabazitaxel (Jevtana)
21-day cycle for up to 10 cycles
References
- de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. link to original article contains verified protocol PubMed
Cabozantinib (Cometriq)
back to top |
Regimen
Study | Evidence |
Smith et al. 2012 | Phase II |
Chemotherapy
- Cabozantinib (Cometriq) 100 mg PO once per day
References
- Smith DC, Smith MR, Sweeney C, Elfiky AA, Logothetis C, Corn PG, Vogelzang NJ, Small EJ, Harzstark AL, Gordon MS, Vaishampayan UN, Haas NB, Spira AI, Lara PN Jr, Lin CC, Srinivas S, Sella A, Schöffski P, Scheffold C, Weitzman AL, Hussain M. Cabozantinib in Patients With Advanced Prostate Cancer: Results of a Phase II Randomized Discontinuation Trial. J Clin Oncol. 2013 Feb 1;31(4):412-9. Epub 2012 Nov 19. link to original article contains verified protocol PubMed
Carboplatin & Docetaxel
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Example orders
Regimen #1
Study | Evidence |
Ross et al. 2008 | Phase II |
Patients enrolled in the trial had hormone-refractory prostate cancer and progression of disease during docetaxel treatment or within 45 days of stopping docetaxel treatment.
Chemotherapy
- Carboplatin (Paraplatin) AUC 4 (Calvert formula) IV over 1 hour once on day 1, given second
- Docetaxel (Taxotere) 60 mg/m2 IV over 1 hour once on day 1, given first
Supportive medications
- "Standard dexamethasone premedication was used"
- Patients continued to receive androgen deprivation therapy
21-day cycles, given until progression of disease or unacceptable toxicity
Regimen #2, weekly docetaxel
Study | Evidence |
Reuter et al. 2010 | Phase II |
Patients enrolled in the trial had progression of disease on docetaxel chemotherapy and castration-resistant disease.
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 30 minutes once on day 1
- Docetaxel (Taxotere) 35 mg/m2 IV over 1 hour once per day on days 1, 8, 15
- Note: In contrast to its abstract, Reuter et al. 2010 sometimes used "days 1, 8, (15)" to describe when docetaxel was given. The paper did not specifically say what "(15)" meant, such as whether this meant that the day 15 dose was optional.
- Prednisone (Sterapred) 5 mg PO BID on days 1 to 28
Supportive medications
- "Standard dexamethasone premedication was used"
- Patients continued to receive LHRH (luteinizing hormone releasing hormone) agonists
- No routine use of granulocyte colony-stimulating factor (G-CSF)
28-day cycles, given until progression of disease or unacceptable toxicity
References
- Ross RW, Beer TM, Jacobus S, Bubley GJ, Taplin ME, Ryan CW, Huang J, Oh WK; Prostate Cancer Clinical Trials Consortium. A phase 2 study of carboplatin plus docetaxel in men with metastatic hormone-refractory prostate cancer who are refractory to docetaxel. Cancer. 2008 Feb 1;112(3):521-6. link to original article contains verified protocol PubMed
- Nakabayashi M, Sartor O, Jacobus S, Regan MM, McKearn D, Ross RW, Kantoff PW, Taplin ME, Oh WK. Response to docetaxel/carboplatin-based chemotherapy as first- and second-line therapy in patients with metastatic hormone-refractory prostate cancer. BJU Int. 2008 Feb;101(3):308-12. link to original article PubMed
- Reuter CW, Morgan MA, Ivanyi P, Fenner M, Ganser A, Grünwald V. Carboplatin plus weekly docetaxel as salvage chemotherapy in docetaxel-resistant and castration-resistant prostate cancer. World J Urol. 2010 Jun;28(3):391-8. Epub 2010 Mar 14. link to original article contains verified protocol PubMed
Carboplatin & Paclitaxel
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Regimen #1
Study | Evidence |
Kentepozidis et al. 2012 | Phase II |
Chemotherapy
- Carboplatin (Paraplatin) AUC 3 (Calvert formula) IV once per day on days 1 & 15, given second
- Paclitaxel (Taxol) 135 mg/m2 IV over 1 hour once per day on days 1 & 15, given first
Supportive medications
- "All patients received a concomitant anti-emetic prophylaxis"
- Dexamethasone (Decadron) 20 mg PO given twice, 12 and 6 hours prior to Paclitaxel (Taxol)
- Diphenhydramine (Benadryl) 50 mg IV once "prior to each dose" (there was nothing else after this in Kentepozidis et al. 2012, and it is assumed to mean prior to each dose of Paclitaxel (Taxol))
- Cimetidine (Tagamet) 300 mg IV once "prior to each dose" (there was nothing else after this in Kentepozidis et al. 2012, and it is assumed to mean prior to each dose of Paclitaxel (Taxol))
- No prophylactic G-CSF
28-day cycles, given until progression of disease or unacceptable toxicity
Regimen #2
Study | Evidence |
Jeske et al. 2010 | Retrospective |
Chemotherapy
- Carboplatin (Paraplatin) AUC 4 to 6 IV once on day 1
- Paclitaxel (Taxol) 60 to 80 mg/m2 IV once per day on days 1, 8, 15
28-day cycles, given until progression of disease or unacceptable toxicity
References
- Jeske S, Tagawa ST, Olowokure O, Selzer J, Giannakakou P, Nanus DM. Carboplatin plus paclitaxel therapy after docetaxel in men with metastatic castrate resistant prostate cancer. Urol Oncol. 2011 Nov-Dec;29(6):676-81. Epub 2010 May 7. link to original article contains verified protocol PubMed
- Kentepozidis N, Soultati A, Giassas S, Vardakis N, Kalykaki A, Kotsakis A, Papadimitraki E, Pantazopoulos N, Bozionellou V, Georgoulias V. Paclitaxel in combination with carboplatin as salvage treatment in patients with castration-resistant prostate cancer: a Hellenic oncology research group multicenter phase II study. Cancer Chemother Pharmacol. 2012 Jul;70(1):161-8. Epub 2012 Jun 3. link to original article contains verified protocol PubMed
CMF
CMF: Cyclophosphamide, Methotrexate, Five-FU
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Regimen
Study | Evidence |
Wozniak et al. 1993 | Phase II |
This regimen is "minimally active in hormone-refractory metastatic prostate cancer" per Wozniak et al. 1993 and is included for historical reference only.
Chemotherapy
- Cyclophosphamide (Cytoxan) 100 mg/m2 PO once per day on days 1 to 7
- Methotrexate (MTX) 15 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 300 mg/m2 IV once on day 1
7-day cycles, given until progression of disease or unacceptable toxicity
References
- Wozniak AJ, Blumenstein BA, Crawford ED, Boileau M, Rivkin SE, Fletcher WS. Cyclophosphamide, methotrexate, and 5-fluorouracil in the treatment of metastatic prostate cancer. A Southwest Oncology Group study. Cancer. 1993 Jun 15;71(12):3975-8. link to original article contains verified protocol PubMed
CPD
CPD: Cyclophosphamide, Prednisone, Diethylstilbestrol
back to top |
Regimen
Study | Evidence |
Hellerstedt et al. 2003 | Phase II |
Chemotherapy
- Cyclophosphamide (Cytoxan) 100 mg PO once per day on days 1 to 20
- Prednisone (Sterapred) 10 mg PO once per day on days 1 to 30
- Diethylstilbestrol (DES) 1 mg PO once per day on days 1 to 30
Supportive medications
- Warfarin (Coumadin) 1 mg PO once per day to decrease risk of DVT
30-day cycles, given until progression of disease or unacceptable toxicity
References
- Hellerstedt B, Pienta KJ, Redman BG, Esper P, Dunn R, Fardig J, Olson K, Smith DC. Phase II trial of oral cyclophosphamide, prednisone, and diethylstilbestrol for androgen-independent prostate carcinoma. Cancer. 2003 Oct 15;98(8):1603-10. link to original article contains verified protocol PubMed
Docetaxel & Prednisone
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Example orders
Regimen #1, every 3-weeks schedule, limited duration
Study | Evidence | ORR, PSA RR | Comparator | Comparator ORR, PSA RR | Pt Population |
Tannock et al. 2004 (TAX 327) | Phase III | pts w/ measurable disease: 12% (95% CI 7-19), 45% (95% CI 40-51) |
Weekly Docetaxel & Prednisone Mitoxantrone & Prednisone |
pts w/ measurable disease: 8% (95% CI 4-14), 48% (95% CI 42-54) 7% (95% CI 3-12), 32% (95% CI 26-37) |
Chemo-naive |
Chemotherapy
- Docetaxel (Taxotere) 75 mg/m2 IV over 1 hour once on day 1
- Prednisone (Sterapred) 5 mg PO BID on days 1 to 21
Supportive medications
- Dexamethasone (Decadron) 8 mg (route not specified) given three times; 12 hours, 3 hours, and 1 hour before Docetaxel (Taxotere)
- Antiemetics "according to local practice"
21-day cycle for up to 10 cycles
Regimen #2, every 3-weeks schedule, indefinite
Study | Evidence | Comparator |
Kellokumpu-Lehtinen et al. 2013 (PROSTY) | Phase III | Every 2-weeks Docetaxel & Prednisone |
Chemotherapy
- Docetaxel (Taxotere) 75 mg/m2 IV over 60 minutes once on day 1
- Prednisolone (Millipred) 10 mg PO once per day on days 1 to 21
Supportive medications
- Dexamethasone (Decadron) 7.5 to 8 mg daily, started 1 day before Docetaxel (Taxotere) and stopped 1 to 2 days after docetaxel infusion (in other words, from day -1 to day 2 or 3); reference did not specify route of administration
- G-CSF not recommended unless patients developed febrile neutropenia or severe infection
- "Treatment with bisphosphonates, erythropoietin, and palliative radiation therapy was allowed"
21-day cycles, given until progression of disease or unacceptable toxicity
Regimen #3, weekly schedule
Study | Evidence | Comparator |
Tannock et al. 2004 (TAX 327) | Phase III | Every 3-week Docetaxel & Prednisone Mitoxantrone & Prednisone |
Chemotherapy
- Docetaxel (Taxotere) 30 mg/m2 IV over 30 minutes once per day on days 1, 8, 15, 22, 29
- Prednisone (Sterapred) 5 mg PO BID on days 1 to 42
Supportive medications
- Dexamethasone (Decadron) 8 mg (route not specified) once 1 hour before Docetaxel (Taxotere)
- Antiemetics "according to local practice"
42-day cycle for up to 5 cycles
Regimen #4
Study | Evidence | Comparator |
Kellokumpu-Lehtinen et al. 2013 (PROSTY | Phase III | Every 3-weeks Docetaxel & Prednisone |
Chemotherapy
- Docetaxel (Taxotere) 50 mg/m2 IV over 60 minutes once per day on days 1 & 15
- Prednisolone (Millipred) 10 mg PO once per day on days 1 to 28
Supportive medications
- Dexamethasone (Decadron) 7.5 to 8 mg once per day, started 1 day before Docetaxel (Taxotere) and stopped 1 to 2 days after docetaxel infusion (in other words, from day -1 to day 2 or 3); reference did not specify route of administration
- G-CSF not recommended unless patients developed febrile neutropenia or severe infection
- "Treatment with bisphosphonates, erythropoietin, and palliative radiation therapy was allowed"
28-day cycles, given until progression of disease or unacceptable toxicity
References
- Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. link to original article contains verified protocol PubMed
- Update: Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. link to original article contains verified protocol PubMed
- Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; for the PROSTY study group. 2-weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. Epub 2013 Jan 4. link to original article contains verified protocol PubMed
Mitoxantrone & Prednisone
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Example orders
Regimen
Study | Evidence | ORR, PSA RR | Comparator | Comparator ORR, PSA RR | Pt Population |
Tannock et al. 2004 (TAX 327) | Phase III | pts w/ measurable disease: 7% (95% CI 3-12), 32% (95% CI 26-37) |
Weekly Docetaxel & Prednisone Every 3-week Docetaxel & Prednisone |
pts w/ measurable disease: 8% (95% CI 4-14), 48% (95% CI 42-54) 12% (95% CI 7-19), 45% (95% CI 40-51) |
Chemo naive |
Petrylak et al. 2004 (SWOG 99-16) | Phase III | Docetaxel & Estramustine | |||
de Bono et al. 2010 (TROPIC) | Phase III | pts w/ measurable disease: 4.4% (95% CI 1.6 - 7.2), 17.8% (95% CI 13.7 - 22.0) |
Cabazitaxel & Prednisone | pts w/ measurable disease: 14.4% (95% CI 9.6 - 19.3), 39.2% (95% CI 33.9 - 44.5) |
Progressed on docetaxel |
Chemotherapy
- Mitoxantrone (Novantrone) 12 mg/m2 IV over 15 to 30 minutes once on day 1
- Prednisone (Sterapred) 10 mg PO once per day (or 5 mg PO BID) on days 1 to 21
21-day cycle for up to 10 cycles
References
- Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. link to original article contains verified protocol PubMed
- Update: Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008 Jan 10;26(2):242-5. link to original article contains verified protocol PubMed
- Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. link to original article PubMed
- de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. link to original article contains verified protocol PubMed
Olaparib (Lynparza)
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Regimen
Study | Evidence |
Kaufman et al. 2014 | Phase II, <20 pts in subgroup |
Mateo et al. 2015 (TOPARP-A) | Phase II |
- Patients in Kaufman et al. 2014 had germline BRCA1/2 mutations and had progression on hormonal and one systemic therapy.
- Patients in Mateo et al. 2015 (TOPARP-A) who were found to have homozygous deletions, deleterious mutations, or both in DNA-repair genes were much more likely to respond to olaparib.
Chemotherapy
- Olaparib (Lynparza) 400 mg PO BID
Given until progression of disease or unacceptable toxicity
References
- Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Steiner M, Loman N, Bowen K, Fielding A, Domchek SM. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015 Jan 20;33(3):244-50. Epub 2014 Nov 3. link to original article contains verified protocol PubMed
- Mateo J, Carreira S, Sandhu S, Miranda S, Mossop H, Perez-Lopez R, Nava Rodrigues D, Robinson D, Omlin A, Tunariu N, Boysen G, Porta N, Flohr P, Gillman A, Figueiredo I, Paulding C, Seed G, Jain S, Ralph C, Protheroe A, Hussain S, Jones R, Elliott T, McGovern U, Bianchini D, Goodall J, Zafeiriou Z, Williamson CT, Ferraldeschi R, Riisnaes R, Ebbs B, Fowler G, Roda D, Yuan W, Wu YM, Cao X, Brough R, Pemberton H, A'Hern R, Swain A, Kunju LP, Eeles R, Attard G, Lord CJ, Ashworth A, Rubin MA, Knudsen KE, Feng FY, Chinnaiyan AM, Hall E, de Bono JS. DNA-Repair Defects and Olaparib in Metastatic Prostate Cancer. N Engl J Med. 2015 Oct 29;373(18):1697-708. link to original article contains verified protocol PubMed
Immunotherapy for metastatic castrate-resistant disease
Ipilimumab & RT
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RT: Radiation Therapy
Regimen
Study | Evidence | ORR | Patient population |
Slovin et al. 2013 | Phase I/II | 4% (95% CI n/a), PSA RR: 16%; | Most had ADT, some had docetaxel use. 10 mg/kg cohort reported here. |
Immunoradiotherapy
- Ipilimumab (Yervoy) 10 mg/kg IV over 90 minutes once on day 1
- Lower doses including 3 mg/kg (the FDA approved dose) were investigated, but the 10 mg/kg dose was recommended in this study
- Concurrent radiotherapy given focally at a single dose of 8 Gy per target bone lesion for up to three bone lesions per patient at 24 to 48 h before the first ipilimumab dose.
21-day cycle for 4 cycles
References
- Slovin SF, Higano CS, Hamid O, Tejwani S, Harzstark A, Alumkal JJ, Scher HI, Chin K, Gagnier P, McHenry MB, Beer TM. Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study. Ann Oncol. 2013 Jul;24(7):1813-21. link to original article contains verified protocol PubMed
Placebo
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Regimen
Study | Evidence | Comparator |
Kantoff et al. 2010 (IMPACT) | Phase III | Sipuleucel-T |
No active antineoplastic treatment; this was the comparator arm in at least one randomized trial and is included for reference purposes, only.
References
- Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. link to original article contains verified protocol PubMed
Sipuleucel-T (Provenge)
Example orders
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Regimen
Study | Evidence | Comparator |
Kantoff et al. 2010 (IMPACT) | Phase III | Placebo |
Immunotherapy
- Sipuleucel-T (Provenge): leukapheresis followed 3 days later with at least 50 million autologous CD54+ cells activated with PAP-GM-CSF, to be done on weeks 0, 2, and 4
Supportive medications
- Acetaminophen (Tylenol) PO once 30 minutes before each dose
- Antihistamine PO once 30 minutes before each dose
References
- Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. link to original article contains verified protocol PubMed
- Safety analysis: Hall SJ, Klotz L, Pantuck AJ, George DJ, Whitmore JB, Frohlich MW, Sims RB. Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. J Urol. 2011 Sep;186(3):877-81. Epub 2011 Jul 23. link to original article contains verified protocol PubMed
- Sipuleucel-T (Provenge) package insert
Radioactive agents for bony metastases
Placebo
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Regimen
Study | Evidence | Comparator |
Nilsson et al. 2007 | Randomized Phase II | Radium-223 |
Parker et al. 2013 (ALSYMPCA) | Phase III | Radium-223 |
No active antineoplastic treatment; this was the comparator arm in at least one randomized trial and is included for reference purposes, only.
References
- Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. link to original article contains verified protocol PubMed
- Update: Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. link to original article contains verified protocol PubMed
- Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. link to original article contains verified protocol PubMed
- Subgroup analysis: Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. link to original article
Radium-223 (Xofigo)
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Regimen #1
Study | Evidence | Comparator |
Parker et al. 2013 (ALSYMPCA) | Phase III | Placebo |
Radiotherapy
- Radium-223 (Xofigo) 50 kBq/kg IV once on day 1
28-day cycle for 6 cycles
Regimen #2
Study | Evidence | Comparator |
Nilsson et al. 2007 | Randomized Phase II | Placebo |
Patients in the study had "bone pain needing EBRT" (external beam radiation therapy). Treatment with radium 223 began within 7 days after EBRT.
Radiotherapy
- Radium-223 (Xofigo) 50 kBq/kg IV once on day 1
28-day cycle for 4 cycles
References
- Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. link to original article contains verified protocol PubMed
- Update: Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. link to original article contains verified protocol PubMed
- Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. link to original article contains verified protocol PubMed
- Subgroup analysis: Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. link to original article
Samarium-153 (Quadramet)
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Regimen
Study | Evidence | Comparator |
Resche et al. 1997 | Phase III | Samarium-153 0.5 mCi/kg |
Sartor et al. 2004 (Quadramet 424Sm10/11 Study Group) | Phase III | Samarium-152 (non-radioactive) |
Radiotherapy
- Samarium-153 (Quadramet) 1 mCi/kg IV over 1 minute once on day 1
Supportive medications
- 1000 mL of fluid PO/IV given twice, 4 hours before and 6 hours after treatment
1 dose
References
- Resche I, Chatal JF, Pecking A, Ell P, Duchesne G, Rubens R, Fogelman I, Houston S, Fauser A, Fischer M, Wilkins D. A dose-controlled study of 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP) in the treatment of patients with painful bone metastases. Eur J Cancer. 1997 Sep;33(10):1583-91. link to original article contains verified protocol PubMed
- Sartor O, Reid RH, Hoskin PJ, Quick DP, Ell PJ, Coleman RE, Kotler JA, Freeman LM, Olivier P; Quadramet 424Sm10/11 Study Group. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology. 2004 May;63(5):940-5. link to original article contains verified protocol PubMed
Measuring disease progression
- Criteria used for disease progression in prostate cancer clinical trials, Prostate Cancer Clinical Trials Working Group 2 (PCWG2):[1]
- Castrate level of serum testosterone is <50 ng/dL (<1.7 nmol/L)
- However, there is controversy/disagreement in other references about whether a lower level should be used, such as <20 ng/dL (0.7 nmol/L)[2]
- PSA rise
- Starting PSA of at least 2.0 ng/mL
- Rising PSA values which are measured at least 1-week apart
- Pretherapy PSA doubling times (PSA-DT) can be estimated if there are at least 3 PSA values measured at least 4 weeks apart
- Bony metastases
- At least 2 new lesions indicates progressive disease
- It is recommended to assess ambiguous results with other imaging modalities such as CT or MRI
- Measurable lesions (RECIST) - this is a lower priority criteria by the PCWG2 because fewer patients have measurable lesions as compared to, for example, bony metastases
- Baseline imaging involves chest imaging with x-ray or CT, CT or MRI of the abdomen/pelvis, and radionuclide bone scan
- It is recommended that local disease is assessed by endorectal MRI or prostatic ultrasound
- Neurologic symptoms should be assessed with MRI of the spine and base of the skull
- Positron emission tomography (PET) is not recommended and is considered investigational
- Measurable lesions should be followed with RECIST criteria
- "Up to 10 visceral and nodal lesions in total should be recorded (with a maximum of five in any one organ)"
- It is suggested that a lymph node must be at least 2 cm in maximal dimension on spiral CT to count as a target lesion.
- Castrate level of serum testosterone is <50 ng/dL (<1.7 nmol/L)
Guidelines
- NCCN Guidelines - Prostate Cancer
- Systemic Therapy in Men With Metastatic Castration-Resistant Prostate Cancer: American Society of Clinical Oncology and Cancer Care Ontario Clinical Practice Guideline - Journal of Clinical Oncology (JCO)
Statistics
- Four-Year Actuarial Progression-Free Probability (PFP) After Salvage Radiotherapy based on Gleason score, PSA, positive margins, etc.[3] (flowchart is in Figure 2)
- SEER Stat Fact Sheets: Prostate Cancer
- CDC Prostate Cancer Statistics
- Cancer.Net Prostate Cancer Statistics
Links
- Decipher, GenomeDx's genomic prognostic prostate cancer assay
- "the Decipher Test uses the expression of these biomarkers to calculate the probability of clinical metastasis within 5 years of radical prostatectomy surgery, and within 3 years of successive PSA rise (biochemical recurrence)."
- MSKCC prostate cancer nomograms
- MSKCC PSA doubling time calculator
- MSKCC Prostate volume calculator
- Oncotype DX Prostate Genomic Health's Genomic Prostate Score (GPS) & prognostic prostate cancer assay
- Partin tables to predict pathologic stage based on clinical TNM stage, PSA, and Gleason score
- PCA3 RNA urine test
- Prolaris, Myriad's biomarker prognostic prostate cancer assay
- Roswell Park's Calculator for Estimating Overall Life Expectancy and Lifetime Risk for Prostate Cancer Death in Newly Diagnosed Men Managed without Definitive Local Therapy
- UCSF-CAPRA score
Quality of life assessment tools
- EPIC-CP: Expanded Prostate Cancer Index Composite for Clinical Practice (BIDMC)
- AUA Symptom Score (OR) (local backup); AUA Symptom Score (UCF) (local backup). Also known as International Prostate Symptom Score (I-PSS/IPSS) or AUASS
References
- ↑ Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. link to original article PubMed
- ↑ Oefelein MG, Feng A, Scolieri MJ, Ricchiutti D, Resnick MI. Reassessment of the definition of castrate levels of testosterone: implications for clinical decision making. Urology. 2000 Dec 20;56(6):1021-4. link to original article PubMed
- ↑ Stephenson AJ, Shariat SF, Zelefsky MJ, Kattan MW, Butler EB, Teh BS, Klein EA, Kupelian PA, Roehrborn CG, Pistenmaa DA, Pacholke HD, Liauw SL, Katz MS, Leibel SA, Scardino PT, Slawin KM. Salvage Radiotherapy for Recurrent Prostate Cancer After Radical Prostatectomy. JAMA. 2004 Mar 17;291(11):1325-32. link to original article PubMed