Prostate cancer - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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.

9 regimens on this page
9 variants on this page


Definitive radiotherapy

Radiation therapy

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Regimen

Study Evidence Comparator Comparative Efficacy
Pilepich et al. 1997 (RTOG 85-31) Phase III (C) Goserelin & RT Inferior DFS
Bolla et al. 1997 (EORTC 22863) Phase III (C) Goserelin & RT Inferior OS
Pilepich et al. 2001 (RTOG 86-10) Phase III (C) Flutamide, Goserelin, RT Seems to have inferior cause-specific mortality
Denham et al. 2005 (TROG 96.01) Phase III (C) 1. Flutamide & Goserelin x 3 mo, RT Inferior EFS (*)
2. Flutamide & Goserelin x 6 mo, RT Inferior OS (*)
D'Amico et al. 2008 (DFCI 95-096) Phase III (C) Flutamide, Goserelin, RT Inferior OS
Jones et al. 2011 (RTOG 94-08) Phase III (C) 1. Flutamide, Goserelin, RT
2. Flutamide, Leuprolide, RT
Seems to have inferior OS
McPartlin et al. 2016 (PMH 9907) Phase III (C) Bicalutamide & RT Seems not superior

Demonstrated to be inferior in almost all studies; here for reference purposes only. Reported efficacy for TROG 96.01 is based on the 2011 update.

Radiotherapy

References

  1. 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
    1. 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
    2. 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
  2. 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
    1. 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
    2. 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
  3. 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
    1. 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
  4. 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
    1. 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
  5. 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
  6. 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
  7. 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 Evidence Comparator Comparative Efficacy
Shamash et al. 2011 Phase III (C) Aspirin, Dexamethasone, Diethylstilbestrol Seems not superior

Hormonotherapy

References

  1. 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

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Parmar et al. 1985 Phase III (C) D-Trp-6-LHRH Seems not superior
Soloway et al. 1991 Phase III (C) Goserelin Seems not superior
Kaisary et al. 1991 Phase III (C) Goserelin Seems not superior
Janknegt et al. 1993 (International Anandron Study) 1986-NR Phase III (C) Nilutamide & Orchiectomy Inferior PFS
Denis et al. 1993 (EORTC 30853) Phase III (C) Flutamide & Goserelin Seems to have inferior OS
Robinson et al. 1995 (EORTC 30805) Phase III (C) 1. Castration & Cyproterone acetate
2. DES
Seems not superior
Bruun et al. 1996 Phase III (C) 1. Buserelin
2. Estrogens
Seems not superior
Boccon-Gibod et al. 1997 Phase III (C) Flutamide Seems not superior
de Voogt et al. 1998 (EORTC 30843) Phase III (C) Buserelin & Cyproterone acetate Seems not superior
Eisenberger et al. 1998 Phase III (C) Flutamide & Orchiectomy Seems not superior
Tyrrell et al. 1998 Phase III (C) Bicalutamide Seems not superior (*)
de Reijke et al. 1999 Phase III (C) Mitomycin & Orchiectomy Seems not superior
Studer et al. 2004 (SAKK 08/88) Phase III (C) Deferred orchiectomy Seems not superior
Millikan et al. 2008 (MDA DM95-231) Phase III (C) ADT & KA/VE Seems not superior

No longer widely used as monotherapy in the United States; included for reference purposes only. Reported efficacy for Tyrrell et al. 1998 is based on the 2000 update.

Hormonotherapy

References

  1. 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
  2. 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
    1. 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
  3. 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
  4. 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
    1. 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
    2. 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
    3. 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
  5. EORTC 30853: 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
    1. 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. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. Eur Urol. 1998;33(2):144-51. PubMed
  6. EORTC 30805: 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
    1. 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
  12. 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
  13. 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
  14. 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

Cortisone monotherapy

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Regimen

Study Evidence
Miller & Hinman 1954 Non-randomized

Hormonotherapy

References

  1. 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 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 Phase III (C) Liarozole Seems not superior

Hormonotherapy

References

  1. 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
  2. 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
  3. 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 Evidence Comparator Comparative Efficacy
Smith et al. 1986 (EORTC 30762) Phase III (E-switch-ic) Estramustine Seems not superior
Osborne et al. 1990 (SWOG S8219) Phase III (C) AC & Orchiectomy Seems not superior
Waymont et al. 1992 Phase III (C) Goserelin Seems to have inferior TTFR

No longer used, but of historical interest.

Hormonotherapy

References

  1. 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
  2. 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
  3. 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

7-day cycles

References

  1. 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 Evidence Comparator Comparative Efficacy
Saxman et al. 1992 Phase III (C) CAM Seems not superior

Chemotherapy

References

  1. 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 Evidence Comparator Comparative Efficacy
Tu et al. 2001 Randomized Phase II (C) Doxorubicin & Strontium-89 Inferior OS
Leaf et al. 2003 (ECOG E3882) Phase III (C) Doxorubicin & DES Seems not superior

Chemotherapy

References

  1. 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
  2. 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 Evidence Comparator Comparative Efficacy
Tu et al. 2001 Randomized Phase II (E-esc) Doxorubicin Superior OS

Preceding treatment

  • Doxorubicin & Ketoconazole alternating with Estramustine & Vinblastine

Chemotherapy

Radiotherapy

References

  1. 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

Placebo

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Regimen

Study Evidence Comparator Comparative Efficacy Comparative Toxicity
Nilsson et al. 2007 Randomized Phase II (C) Radium-223 Might have inferior OS
Kantoff et al. 2010 (IMPACTprostate) Phase III (C) Sipuleucel-T Seems to have inferior OS
Scher et al. 2012 (AFFIRM) Phase III (C) Enzalutamide Inferior OS
Parker et al. 2013 (ALSYMPCA) Phase III (C) Radium-223 Inferior OS Inferior EQ-5D score
Kwon et al. 2014 (CA184-043) Phase III (C) Ipilimumab Might have inferior OS
Beer et al. 2014 (PREVAIL) Phase III (C) Enzalutamide Inferior OS Worse HRQoL
Beer et al. 2016 Phase III (C) Ipilimumab Seems not superior

No active antineoplastic treatment; this was the comparator arm in at least one randomized trial and is included for reference purposes, only.

References

  1. D9901: Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94. link to original article PubMed
    1. Pooled Update: Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9. link to original article PubMed
  2. 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
    1. 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
  3. IMPACT: 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
  4. AFFIRM: 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
  5. ALSYMPCA: 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
    1. Subgroup analysis: Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland ØS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. Epub 2014 May 13. link to original article PubMed
    2. Subgroup analysis: Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. 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. Lancet Oncol. 2014 Nov;15(12):1397-406. Epub 2014 Oct 17. link to original article PubMed
    3. HRQoL analysis: Nilsson S, Cislo P, Sartor O, Vogelzang NJ, Coleman RE, O'Sullivan JM, Reuning-Scherer J, Shan M, Zhan L, Parker C. Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study. Ann Oncol. 2016 May;27(5):868-74. Epub 2016 Feb 23. link to original article link to PMC article PubMed
  6. CA184-043: Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. Epub 2014 May 13. link to original article link to PMC article PubMed
  7. PREVAIL: 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 link to PMC article PubMed
    1. Update: Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in men with chemotherapy-naïve metastatic castration-resistant prostate cancer: Extended analysis of the phase 3 PREVAIL study. Eur Urol. 2017 Feb;71(2):151-154. Epub 2016 Jul 28. link to original article link to PMC article PubMed
    2. HRQoL analysis: Devlin N, Herdman M, Pavesi M, Phung, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. link to original article link to PMC article PubMed
  8. Beer TM, Kwon ED, Drake CG, Fizazi K, Logothetis C, Gravis G, Ganju V, Polikoff J, Saad F, Humanski P, Piulats JM, Gonzalez Mella P, Ng SS, Jaeger D, Parnis FX, Franke FA, Puente J, Carvajal R, Sengeløv L, McHenry MB, Varma A, van den Eertwegh AJ, Gerritsen W. Randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naive castration-resistant prostate cancer. J Clin Oncol. 2017 Jan;35(1):40-47. Epub 2016 Oct 31. link to original article PubMed

Vinblastine monotherapy

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Regimen

Study Evidence Comparator Comparative Efficacy
Hudes et al. 1999 Phase III (C) Estramustine & Vinblastine Might have inferior OS

Chemotherapy

References

  1. 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