Difference between revisions of "Prostate cancer - historical"
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|[[Prostate_cancer#Goserelin_monotherapy_2|Goserelin]] | |[[Prostate_cancer#Goserelin_monotherapy_2|Goserelin]] | ||
|style="background-color:#ffffbf"|Did not meet efficacy endpoints | |style="background-color:#ffffbf"|Did not meet efficacy endpoints | ||
+ | |- | ||
+ | |[https://doi.org/10.1002/cncr.1990.66.s5.1045 Keuppens et al. 1990 (EORTC 30853)] | ||
+ | |1986-1988 | ||
+ | |style="background-color:#1a9851"|Phase III (C) | ||
+ | |[[Prostate_cancer#Flutamide_.26_Goserelin|Flutamide & Goserelin]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior OS<sup>1</sup> | ||
|- | |- | ||
|[https://doi.org/10.1016/s0022-5347(17)36003-2 Janknegt et al. 1993 (International Anandron Study)] | |[https://doi.org/10.1016/s0022-5347(17)36003-2 Janknegt et al. 1993 (International Anandron Study)] | ||
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|[[Prostate_cancer#Nilutamide_.26_Orchiectomy|Nilutamide & Orchiectomy]] | |[[Prostate_cancer#Nilutamide_.26_Orchiectomy|Nilutamide & Orchiectomy]] | ||
|style="background-color:#d73027"|Inferior PFS | |style="background-color:#d73027"|Inferior PFS | ||
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− | |||
− | |||
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|- | |- | ||
|[https://www.tandfonline.com/doi/abs/10.3109/00365599609182309 Bruun et al. 1996] | |[https://www.tandfonline.com/doi/abs/10.3109/00365599609182309 Bruun et al. 1996] | ||
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|style="background-color:#1a9851"|Phase III (C) | |style="background-color:#1a9851"|Phase III (C) | ||
|[[Prostate_cancer#Bicalutamide_monotherapy|Bicalutamide]] | |[[Prostate_cancer#Bicalutamide_monotherapy|Bicalutamide]] | ||
− | | style="background-color:#ffffbf" |Seems not superior<sup> | + | | style="background-color:#ffffbf" |Seems not superior<sup>2</sup> |
|- | |- | ||
|[https://www.auajournals.org/doi/full/10.1016/S0022-5347%2805%2968191-8 de Reijke et al. 1999] | |[https://www.auajournals.org/doi/full/10.1016/S0022-5347%2805%2968191-8 de Reijke et al. 1999] | ||
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|- | |- | ||
|} | |} | ||
− | ''<sup>1</sup>Reported efficacy for Tyrrell et al. 1998 is based on the 2000 update.''<br> | + | ''<sup>1</sup>Reported efficacy for EORTC 30853 is based on the 1998 final update.''<br> |
+ | ''<sup>2</sup>Reported efficacy for Tyrrell et al. 1998 is based on the 2000 update.''<br> | ||
''No longer widely used as monotherapy in the United States; included for reference purposes only.'' | ''No longer widely used as monotherapy in the United States; included for reference purposes only.'' | ||
====Endocrine therapy==== | ====Endocrine therapy==== | ||
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===References=== | ===References=== | ||
# Parmar H, Phillips RH, Lightman SL, Edwards L, Allen L, Schally AV. Randomised controlled study of orchidectomy vs long-acting D-Trp-6-LHRH microcapsules in advanced prostatic carcinoma. Lancet. 1985 Nov 30;2(8466):1201-5. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(85)90739-1/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/2866289 PubMed] | # Parmar H, Phillips RH, Lightman SL, Edwards L, Allen L, Schally AV. Randomised controlled study of orchidectomy vs long-acting D-Trp-6-LHRH microcapsules in advanced prostatic carcinoma. Lancet. 1985 Nov 30;2(8466):1201-5. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(85)90739-1/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/2866289 PubMed] | ||
+ | #'''EORTC 30853:''' Keuppens F, Denis L, Smith P, Carvalho AP, Newling D, Bond A, Sylvester R, De Pauw M, Vermeylen K, Ongena P; EORTC GU Group. Zoladex and flutamide versus bilateral orchiectomy: a randomized phase III EORTC 30853 study. Cancer. 1990 Sep 1;66(5 Suppl):1045-57. [https://doi.org/10.1002/cncr.1990.66.s5.1045 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2144206/ PubMed] | ||
+ | ##'''Update:''' Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M; [[Study_Groups#EORTC|EORTC]] GU Group. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). Urology. 1993 Aug;42(2):119-29. [https://www.goldjournal.net/article/0090-4295(93)90634-M/pdf link to original article] '''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; [[Study_Groups#EORTC|EORTC]] Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. Eur Urol. 1998;33(2):144-51. [https://doi.org/10.1159/000019546 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9519355 PubMed] | ||
# Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC; Zoladex Prostate Study Group. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Urology. 1991 Jan;37(1):46-51. [https://www.goldjournal.net/article/0090-4295(91)80077-K/pdf link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/1824732 PubMed] | # Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC; Zoladex Prostate Study Group. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Urology. 1991 Jan;37(1):46-51. [https://www.goldjournal.net/article/0090-4295(91)80077-K/pdf link to original article] [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; Zoladex Prostate Study Group. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. 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] | ## '''Update:''' Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT; Zoladex Prostate Study Group. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. 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] | ||
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## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM; International Anandron Study Group. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. J Urol. 1997 Jul;158(1):160-3. [https://www.ncbi.nlm.nih.gov/pubmed/9186345 PubMed] | ## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM; International Anandron Study Group. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. 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''' [https://www.ncbi.nlm.nih.gov/pubmed/12160584 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''' [https://www.ncbi.nlm.nih.gov/pubmed/12160584 PubMed] | ||
− | |||
− | |||
# '''EORTC 30805:''' Robinson MR. A further analysis of European Organization for Research and Treatment of Cancer protocol 30805: orchidectomy versus orchidectomy plus cyproterone acetate versus low-dose diethylstilbestrol. Cancer. 1993 Dec 15;72(12 Suppl):3855-7. [https://doi.org/10.1002/1097-0142(19931215)72:12+%3C3855::aid-cncr2820721718%3E3.0.co;2-i link to original article] [https://pubmed.ncbi.nlm.nih.gov/8252503 PubMed] | # '''EORTC 30805:''' Robinson MR. A further analysis of European Organization for Research and Treatment of Cancer protocol 30805: orchidectomy versus orchidectomy plus cyproterone acetate versus low-dose diethylstilbestrol. Cancer. 1993 Dec 15;72(12 Suppl):3855-7. [https://doi.org/10.1002/1097-0142(19931215)72:12+%3C3855::aid-cncr2820721718%3E3.0.co;2-i link to original article] [https://pubmed.ncbi.nlm.nih.gov/8252503 PubMed] | ||
## '''Update:''' Robinson MR, Smith PH, Richards B, Newling DW, de Pauw M, Sylvester R. The final analysis of the EORTC Genito-Urinary Tract Cancer Co-Operative Group phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate. Eur Urol. 1995;28(4):273-83. [https://www.karger.com/Article/Abstract/475067 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/8575493 PubMed] | ## '''Update:''' Robinson MR, Smith PH, Richards B, Newling DW, de Pauw M, Sylvester R. The final analysis of the EORTC Genito-Urinary Tract Cancer Co-Operative Group phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate. Eur Urol. 1995;28(4):273-83. [https://www.karger.com/Article/Abstract/475067 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/8575493 PubMed] |
Revision as of 14:00, 11 May 2021
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main prostate cancer page for current regimens.
12 regimens on this page
14 variants on this page
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Definitive radiotherapy
Radiation therapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Pilepich et al. 2001 (RTOG 86-10) | 1987-1991 | Phase III (C) | Flutamide, Goserelin, RT | Seems to have inferior cause-specific mortality |
Pilepich et al. 1997 (RTOG 85-31) | 1987-1992 | Phase III (C) | Goserelin & RT | Inferior DFS |
Bolla et al. 1997 (EORTC 22863) | 1987-1995 | Phase III (C) | Goserelin & RT | Inferior OS |
Jones et al. 2011 (RTOG 94-08) | 1994-2001 | Phase III (C) | 1. Flutamide, Goserelin, RT 2. Flutamide, Leuprolide, RT |
Seems to have inferior OS |
D'Amico et al. 2008 (DFCI 95-096) | 1995-2001 | Phase III (C) | Flutamide, Goserelin, RT | Inferior OS |
Denham et al. 2005 (TROG 96.01) | 1996-2000 | Phase III (C) | 1. Flutamide & Goserelin x 3 mo, RT | Inferior EFS1 |
2. Flutamide & Goserelin x 6 mo, RT | Inferior OS1 | |||
McPartlin et al. 2016 (PMH 9907) | 1999-2006 | Phase III (C) | Bicalutamide & RT | Seems not superior |
1Reported efficacy for TROG 96.01 is based on the 2011 update.
Demonstrated to be inferior in almost all studies; here for reference purposes only.
Radiotherapy
- External beam radiotherapy of varying doses (see papers for details)
References
- RTOG 85-31: 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
- EORTC 22863: 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
- Update: Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. link to original article PubMed
- Update: Bolla M, Van Tienhoven G, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Billiet I, Torecilla JL, Pfeffer R, Cutajar CL, Van der Kwast T, Collette L. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncol. 2010 Nov;11(11):1066-73. Epub 2010 Oct 7. link to original article PubMed
- RTOG 86-10: 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
- TROG 96.01: 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
- Update: Denham JW, Steigler A, Lamb DS, Joseph D, Turner S, Matthews J, Atkinson C, North J, Christie D, Spry NA, Tai KH, Wynne C, D'Este C. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol. 2011 May;12(5):451-9. link to original article PubMed
- DFCI 95-096: 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
- RTOG 94-08: 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
- PMH 9907: McPartlin AJ, Glicksman R, Pintilie M, Tsuji D, Mok G, Bayley A, Chung P, Bristow RG, Gospodarowicz MK, Catton CN, Milosevic M, Warde PR. PMH 9907: Long-term outcomes of a randomized phase 3 study of short-term bicalutamide hormone therapy and dose-escalated external-beam radiation therapy for localized prostate cancer. Cancer. 2016 Aug 15;122(16):2595-603. Epub 2016 May 24. link to original article PubMed
Hormonal therapy for locally advanced or metastatic disease
Aspirin & Dexamethasone
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DA: Dexamethasone & Aspirin
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Shamash et al. 2011 | 2001-2008 | Phase III (C) | Aspirin, Dexamethasone, Diethylstilbestrol | Seems not superior |
Endocrine therapy
References
- Shamash J, Powles T, Sarker SJ, Protheroe A, Mithal N, Mills R, Beard R, Wilson P, Tranter N, O'Brien N, McFaul S, Oliver T. A multi-centre randomised phase III trial of dexamethasone vs dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred diethylstilbestrol. Br J Cancer. 2011 Feb 15;104(4):620-8. Epub 2011 Feb 1. link to original article link to PMC article PubMed
Castration
back to top |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Parmar et al. 1985 | 1984-1985 | Phase III (C) | D-Trp-6-LHRH | Seems not superior |
Soloway et al. 1991 | NR | Phase III (C) | Goserelin | Did not meet efficacy endpoints |
Robinson 1993 (EORTC 30805) | 1981-1986 | Phase III (C) | 1. Castration & Cyproterone acetate 2. DES |
Seems not superior |
Kaisary et al. 1991 | 1983-1986 | Phase III (C) | Goserelin | Did not meet efficacy endpoints |
Keuppens et al. 1990 (EORTC 30853) | 1986-1988 | Phase III (C) | Flutamide & Goserelin | Seems to have inferior OS1 |
Janknegt et al. 1993 (International Anandron Study) | 1986-NR | Phase III (C) | Nilutamide & Orchiectomy | Inferior PFS |
Bruun et al. 1996 | NR | Phase III (C) | 1. Buserelin 2. Estrogens |
Seems not superior |
Studer et al. 2004 (SAKK 08/88) | 1988-1992 | Phase III (C) | Deferred orchiectomy | Seems not superior |
Boccon-Gibod et al. 1997 | 1989-1991 | Phase III (C) | Flutamide | Seems not superior |
de Voogt et al. 1998 (EORTC 30843) | NR in abstract | Phase III (C) | Buserelin & Cyproterone acetate | Seems not superior |
Eisenberger et al. 1998 | 1989-1994 | Phase III (C) | Flutamide & Orchiectomy | Seems not superior |
Tyrrell et al. 1998 | NR in abstract | Phase III (C) | Bicalutamide | Seems not superior2 |
de Reijke et al. 1999 | 1990-1995 | Phase III (C) | Mitomycin & Orchiectomy | Seems not superior |
Millikan et al. 2008 (MDA DM95-231) | 1996-2003 | Phase III (C) | ADT & KA/VE | Seems not superior |
1Reported efficacy for EORTC 30853 is based on the 1998 final update.
2Reported efficacy for Tyrrell et al. 1998 is based on the 2000 update.
No longer widely used as monotherapy in the United States; included for reference purposes only.
Endocrine therapy
References
- Parmar H, Phillips RH, Lightman SL, Edwards L, Allen L, Schally AV. Randomised controlled study of orchidectomy vs long-acting D-Trp-6-LHRH microcapsules in advanced prostatic carcinoma. Lancet. 1985 Nov 30;2(8466):1201-5. link to original article PubMed
- EORTC 30853: Keuppens F, Denis L, Smith P, Carvalho AP, Newling D, Bond A, Sylvester R, De Pauw M, Vermeylen K, Ongena P; EORTC GU Group. Zoladex and flutamide versus bilateral orchiectomy: a randomized phase III EORTC 30853 study. Cancer. 1990 Sep 1;66(5 Suppl):1045-57. link to original article PubMed
- Update: Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M; EORTC GU Group. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). Urology. 1993 Aug;42(2):119-29. link to original article contains protocol PubMed
- Update: Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R; EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. Eur Urol. 1998;33(2):144-51. link to original article PubMed
- Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC; Zoladex Prostate Study Group. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Urology. 1991 Jan;37(1):46-51. link to original article PubMed
- Update: Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT; Zoladex Prostate Study Group. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. 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. link to original article PubMed
- International Anandron Study: Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM, Dijkman GD, Frick J, Goedhals J, Knönagel H, Venner PM. 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. link to original article PubMed
- Update: Janknegt RA; Anandron International Study Group. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. PubMed
- Update: Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM; International Anandron Study Group. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. 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
- EORTC 30805: Robinson MR. A further analysis of European Organization for Research and Treatment of Cancer protocol 30805: orchidectomy versus orchidectomy plus cyproterone acetate versus low-dose diethylstilbestrol. Cancer. 1993 Dec 15;72(12 Suppl):3855-7. link to original article PubMed
- Update: Robinson MR, Smith PH, Richards B, Newling DW, de Pauw M, Sylvester R. The final analysis of the EORTC Genito-Urinary Tract Cancer Co-Operative Group phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate. Eur Urol. 1995;28(4):273-83. link to original article PubMed
- Bruun E, Frimodt-Møller C; Danish Buserelin Study Group. The effect of Buserelin versus conventional antiandrogenic treatment in patients with T2-4NXM1 prostatic cancer; A prospective, randomized multicentre phase III trial. Scand J Urol Nephrol. 1996 Aug;30(4):291-7. link to original article 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. link to original article contains protocol PubMed
- EORTC 30843: de Voogt HJ, Studer U, Schröder FH, Klijn JG, de Pauw M, Sylvester R; EORTC Genito-Urinary Tract Cancer Cooperative Group. Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer: final analysis of EORTC GU Group Trial 30843. Eur Urol. 1998;33(2):152-8. link to original article PubMed
- Eisenberger MA, Blumenstein BA, Crawford ED, Miller G, McLeod DG, Loehrer PJ, Wilding G, Sears K, Culkin DJ, Thompson IM Jr, Bueschen AJ, Lowe BA. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998 Oct 8;339(15):1036-42. link to original article 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. link to original article 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
- de Reijke TM, Keuppens FI, Whelan P, Kliment J, Robinson MR, Rea LA, Sylvester RJ; European Organisation for Research in Cancer Therapy Genitourinary Group. Orchiectomy and orchiectomy plus mitomycin C for metastatic prostate cancer in patients with poor prognosis: the final results of a European Organisation for Research in Cancer Therapy Genitourinary Group trial. J Urol. 1999 Nov;162(5):1658-64. link to original article PubMed
- SAKK 08/88: Studer UE, Hauri D, Hanselmann S, Chollet D, Leisinger HJ, Gasser T, Senn E, Trinkler FB, Tscholl RM, Thalmann GN, Dietrich D. Immediate versus deferred hormonal treatment for patients with prostate cancer who are not suitable for curative local treatment: results of the randomized trial SAKK 08/88. J Clin Oncol. 2004 Oct 15;22(20):4109-18. Erratum in: J Clin Oncol. 2005 Feb 1;23(4):936. link to original article PubMed
- MDA DM95-231: Millikan RE, Wen S, Pagliaro LC, Brown MA, Moomey B, Do KA, Logothetis CJ. Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. J Clin Oncol. 2008 Dec 20;26(36):5936-42. Epub 2008 Nov 24. link to original article link to PMC article PubMed NCT00002855
Cortisone monotherapy
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Regimen
Study | Evidence |
---|---|
Miller & Hinman 1954 | Non-randomized |
Endocrine therapy
References
- Miller GM, Hinman F Jr. Cortisone treatment in advanced carcinoma of the prostate. J Urol. 1954 Sep;72(3):485-96. link to original article PubMed
Cyproterone acetate monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Jacobi et al. 1980 | NR | Phase III (E-switch-ic) | Estradiol undecylate | Seems to have superior ORR |
Pavone-Macaluso et al. 1986 (EORTC 30761) | 1977-1981 | Phase III (E-switch-ic) | 1. DES | Seems not superior |
2. MPA | Seems to have superior OS | |||
Debruyne et al. 1998 | 1992-1994 | Phase III (C) | Liarozole | Seems not superior |
Endocrine therapy
References
- Jacobi GH, Altwein JE, Kurth KH, Basting R, Hohenfellner R. Treatment of advanced prostatic cancer with parenteral cyproterone acetate: a phase III randomised trial. Br J Urol. 1980 Jun;52(3):208-15. link to original article PubMed
- EORTC 30761: Pavone-Macaluso M, de Voogt HJ, Viggiano G, Barasolo E, Lardennois B, de Pauw M, Sylvester R. Comparison of diethylstilbestrol, cyproterone acetate and medroxyprogesterone acetate in the treatment of advanced prostatic cancer: final analysis of a randomized phase III trial of the European Organisation for Research on Treatment of Cancer Urological Group. J Urol. 1986 Sep;136(3):624-31. link to original article PubMed
- Debruyne FJ, Murray R, Fradet Y, Johansson JE, Tyrrell C, Boccardo F, Denis L, Marberger JM, Brune D, Rassweiler J, Vangeneugden T, Bruynseels J, Janssens M, De Porre P; Liarozole Study Group. Liarozole--a novel treatment approach for advanced prostate cancer: results of a large randomized trial versus cyproterone acetate. Urology. 1998 Jul;52(1):72-81. link to original article PubMed
DES monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Smith et al. 1986 (EORTC 30762) | 1976-1980 | Phase III (E-switch-ic) | Estramustine | Seems not superior |
Osborne et al. 1990 (SWOG S8219) | 1982-1986 | Phase III (C) | AC & Orchiectomy | Seems not superior |
Waymont et al. 1992 | 1985-1987 | Phase III (C) | Goserelin | Seems to have inferior TTFR |
No longer used, but of historical interest.
Endocrine therapy
References
- EORTC 30762: Smith PH, Suciu S, Robinson MR, Richards B, Bastable JR, Glashan RW, Bouffioux C, Lardennois B, Williams RE, de Pauw M, Sylvester R. A comparison of the effect of diethylstilbestrol with low dose estramustine phosphate in the treatment of advanced prostatic cancer: final analysis of a phase III trial of the European Organisation for Research on Treatment of Cancer. J Urol. 1986 Sep;136(3):619-23. link to original article PubMed
- SWOG S8219: Osborne CK, Blumenstein B, Crawford ED, Coltman CA Jr, Smith AY, Lambuth BW, Chapman RA. Combined versus sequential chemo-endocrine therapy in advanced prostate cancer: final results of a randomized Southwest Oncology Group study. J Clin Oncol. 1990 Oct;8(10):1675-82. link to original article PubMed
- Waymont B, Lynch TH, Dunn JA, Emtage LA, Arkell DG, Wallace DM, Blackledge GR. Phase III randomised study of zoladex versus stilboestrol in the treatment of advanced prostate cancer. Br J Urol. 1992 Jun;69(6):614-20. link to original article PubMed
Chemotherapy for metastatic disease
CMF
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CMF: Cyclophosphamide, Methotrexate, 5-Fluorouracil
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
References
- Wozniak AJ, Blumenstein BA, Crawford ED, Boileau M, Rivkin SE, Fletcher WS; SWOG. 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
Cyclophosphamide monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Saxman et al. 1992 | 1984-1989 | Phase III (C) | CAM | Seems not superior |
Chemotherapy
References
- Saxman S, Ansari R, Drasga R, Miller M, Wheeler B, McClean J, Einhorn L; Hoosier Oncology Group. Phase III trial of cyclophosphamide versus cyclophosphamide, doxorubicin, and methotrexate in hormone-refractory prostatic cancer: a Hoosier Oncology Group study. Cancer. 1992 Nov 15;70(10):2488-92. link to original article PubMed
Doxorubicin monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Leaf et al. 2003 (ECOG E3882) | 1983-1986 | Phase III (C) | Doxorubicin & DES | Seems not superior |
Tu et al. 2001 | 1996-1999 | Randomized Phase II (C) | Doxorubicin & Strontium-89 | Inferior OS |
Chemotherapy
References
- Tu SM, Millikan RE, Mengistu B, Delpassand ES, Amato RJ, Pagliaro LC, Daliani D, Papandreou CN, Smith TL, Kim J, Podoloff DA, Logothetis CJ. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet. 2001 Feb 3;357(9253):336-41. Erratum in: Lancet 2001 Apr 14;357(9263):1210. link to original article PubMed
- ECOG E3882: Leaf AN, Propert K, Corcoran C, Catalano PJ, Trump DL, Harris JE, Davis TE. Phase III study of combined chemohormonal therapy in metastatic prostate cancer (ECOG 3882): an Eastern Cooperative Oncology Group study. Med Oncol. 2003;20(2):137-46. link to original article PubMed
Doxorubicin & Strontium-89
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tu et al. 2001 | 1996-1999 | Randomized Phase II (E-esc) | Doxorubicin | Superior OS |
Preceding treatment
- Doxorubicin & Ketoconazole alternating with Estramustine & Vinblastine
Chemotherapy
Radiotherapy
References
- Tu SM, Millikan RE, Mengistu B, Delpassand ES, Amato RJ, Pagliaro LC, Daliani D, Papandreou CN, Smith TL, Kim J, Podoloff DA, Logothetis CJ. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet. 2001 Feb 3;357(9253):336-41. Erratum in: Lancet 2001 Apr 14;357(9263):1210. link to original article PubMed
Vinblastine monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Hudes et al. 1999 | 1993-1995 | Phase III (C) | Estramustine & Vinblastine | Might have inferior OS |
Chemotherapy
References
- Hudes G, Einhorn L, Ross E, Balsham A, Loehrer P, Ramsey H, Sprandio J, Entmacher M, Dugan W, Ansari R, Monaco F, Hanna M, Roth B; Hoosier Oncology Group; Fox Chase Network. Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer: A Hoosier Oncology Group and Fox Chase Network phase III trial. J Clin Oncol. 1999 Oct;17(10):3160-6. link to original article PubMed