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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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

12 regimens on this page
14 variants on this page


Definitive radiotherapy

Radiation therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Pilepich et al. 1995 1987-1991 Phase 3 (C) Flutamide, Goserelin, RT Inferior DFS
Pilepich et al. 2001 (RTOG 86-10) 1987-1991 Phase 3 (C) Flutamide, Goserelin, RT Seems to have inferior cause-specific mortality
Pilepich et al. 1997 (RTOG 85-31) 1987-1992 Phase 3 (C) Goserelin & RT Inferior DFS
Bolla et al. 1997 (EORTC 22863) 1987-1995 Phase 3 (C) Goserelin & RT Inferior OS
Jones et al. 2011 (RTOG 94-08) 1994-2001 Phase 3 (C) 1a. Flutamide, Goserelin, RT
1b. Flutamide, Leuprolide, RT 		Seems to have inferior OS
D'Amico et al. 2008 (DFCI 95-096) 1995-2001 Randomized (C) Flutamide, Goserelin, RT Inferior OS
Denham et al. 2005 (TROG 96.01) 1996-2000 Phase 3 (C) 1. Flutamide, Goserelin, RT; 3 months of ADT Inferior EFS1
2. Flutamide, Goserelin, RT; 6 months of ADT Inferior OS1
McPartlin et al. 2016 (PMH 9907) 1999-2006 Phase 3 (C) Bicalutamide & RT Did not meet primary endpoint of BFI
Krauss et al. 2023 (RTOG 0815) 2009-09 to 2016-03 Phase 3 (C) ADT & RT Did not meet primary endpoint of OS

1Reported efficacy for TROG 96.01 is based on the 2011 update.
Note: Demonstrated to be inferior in almost all studies; here for reference purposes only.

Radiotherapy

References

  1. Pilepich MV, Krall JM, al-Sarraf M, John MJ, Doggett RL, Sause WT, Lawton CA, Abrams RA, Rotman M, Rubin P, Shipley WU, Grignon D, Caplan R, Cox JD; Radiation Therapy Oncology Group. Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostatic carcinoma: a randomized comparative trial of the Radiation Therapy Oncology Group. Urology. 1995 Apr;45(4):616-23. link to original article PubMed
  2. 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 dosing details in abstract 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 dosing details in abstract 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 dosing details in manuscript PubMed
  3. 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 NCT00849082
    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
  4. 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 dosing details in manuscript 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 dosing details in manuscript PubMed
  5. 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 dosing details in abstract PubMed ACTRN12607000237482
    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
  6. 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 NCT00116220
  7. 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 dosing details in manuscript PubMed NCT00002597
  8. 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
  9. EORTC 22991: Bolla M, Maingon P, Carrie C, Villa S, Kitsios P, Poortmans PM, Sundar S, van der Steen-Banasik EM, Armstrong J, Bosset JF, Herrera FG, Pieters B, Slot A, Bahl A, Ben-Yosef R, Boehmer D, Scrase C, Renard L, Shash E, Coens C, van den Bergh AC, Collette L. Short androgen suppression and radiation dose escalation for intermediate- and high-risk localized prostate cancer: results of EORTC trial 22991. J Clin Oncol. 2016 May 20;34(15):1748-56. Epub 2016 Mar 14. link to original article PubMed NCT00021450
    1. Subgroup analysis: Bolla M, Neven A, Maingon P, Carrie C, Boladeras A, Andreopoulos D, Engelen A, Sundar S, van der Steen-Banasik EM, Armstrong J, Peignaux-Casasnovas K, Boustani J, Herrera FG, Pieters BR, Slot A, Bahl A, Scrase CD, Azria D, Jansa J, O'Sullivan JM, Van Den Bergh ACM, Collette L; EORTC Radiation Oncology Group. Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease. J Clin Oncol. 2021 Sep 20;39(27):3022-3033. Epub 2021 Jul 26. link to original article PubMed
  10. RTOG 0815: Krauss DJ, Karrison T, Martinez AA, Morton G, Yan D, Bruner DW, Movsas B, Elshaikh M, Citrin D, Hershatter B, Michalski JM, Efstathiou JA, Currey A, Kavadi VS, Cury FL, Lock M, Raben A, Seaward SA, El-Gayed A, Rodgers JP, Sandler HM. Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial. J Clin Oncol. 2023 Jun 10;41(17):3203-3216. Epub 2023 Apr 27. link to original article link to PMC article PubMed NCT00936390
    1. PRO analysis: Movsas B, Rodgers JP, Elshaikh MA, Martinez AA, Morton GC, Krauss DJ, Yan D, Citrin DE, Hershatter BW, Michalski JM, Ellis RJ, Kavadi VS, Gore EM, Gustafson GS, Schulz CA, Velker VM, Olson AC, Cury FL, Papagikos MA, Karrison TG, Sandler HM, Bruner DW. Dose-Escalated Radiation Alone or in Combination With Short-Term Total Androgen Suppression for Intermediate-Risk Prostate Cancer: Patient-Reported Outcomes From NRG/Radiation Therapy Oncology Group 0815 Randomized Trial. J Clin Oncol. 2023 Jun 10;41(17):3217-3224. Epub 2023 Apr 27. link to original article link to PMC article PubMed

Hormonal therapy for locally advanced or metastatic disease

Castration

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Parmar et al. 1985 1984-01 to 1985-07 Phase 3 (C) D-Trp-6-LHRH Seems not superior
Soloway et al. 1991 NR Phase 3 (C) Goserelin Did not meet efficacy endpoints
Robinson 1993 (EORTC 30805) 1981-1986 Phase 3 (C) 1. Castration & Cyproterone acetate
2. DES 		Seems not superior
Kaisary et al. 1991 1983-1986 Phase 3 (C) Goserelin Did not meet efficacy endpoints
Keuppens et al. 1990 (EORTC 30853) 1986-1988 Phase 3 (C) Flutamide & Goserelin Seems to have inferior OS1
Janknegt et al. 1993 (International Anandron Study) 1986-NR Phase 3 (C) Nilutamide & Orchiectomy Inferior PFS
Bruun et al. 1996 NR Phase 3 (C) 1. Buserelin
2. Estrogens 		Seems not superior
Studer et al. 2004 (SAKK 08/88) 1988-1992 Phase 3 (C) Orchiectomy; deferred Seems not superior
Boccon-Gibod et al. 1997 1989-1991 Phase 3 (C) Flutamide Did not meet primary endpoint of PFS
de Voogt et al. 1998 (EORTC 30843) NR in abstract Phase 3 (C) Buserelin & Cyproterone acetate Seems not superior
Eisenberger et al. 1998 1989-1994 Phase 3 (C) Flutamide & Orchiectomy Seems not superior
Tyrrell et al. 1998 NR in abstract Phase 3 (C) Bicalutamide Seems not superior2
de Reijke et al. 1999 1990-1995 Phase 3 (C) Mitomycin & Orchiectomy Seems not superior
Millikan et al. 2008 (MDA DM95-231) 1996-2003 Phase 3 (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.
Note: This procedure is no longer widely used as monotherapy in the United States; included for reference purposes only.

Endocrine therapy

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. 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
    1. Update: Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, De Pauw 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 dosing details in abstract PubMed
    2. 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
  3. 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 dosing details in manuscript PubMed
  4. 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
  5. 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. link to original article 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. link to original article 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 dosing details in manuscript PubMed
  6. 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
    1. 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
  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 dosing details in abstract 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 dosing details in abstract 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 dosing details in manuscript 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 NCT00002855
  15. ECOG E8892: NCT00002881

Cortisone monotherapy

Regimen

Study Evidence
Miller & Hinman 1954 Non-randomized

Endocrine therapy

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

Regimen variant #1, IM

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Jacobi et al. 1980 NR Phase 3 (E-switch-ic) Estradiol undecylate Seems to have superior ORR

Endocrine therapy

7-day cycles


Regimen variant #2, PO 200 mg/day

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Debruyne et al. 1998 1992-1994 Phase 3 (C) Liarozole Seems to have inferior OS

Endocrine therapy

Continued indefinitely


Regimen variant #3, PO 250 mg/day

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Pavone-Macaluso et al. 1986 (EORTC 30761) 1977-1981 Phase 3 (E-switch-ic) 1. DES Seems not superior
2. MPA Seems to have superior OS

Endocrine therapy

Continued indefinitely

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 contains dosing details in abstract 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 contains dosing details in manuscript 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 contains dosing details in manuscript PubMed

DES monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Smith et al. 1986 (EORTC 30762) 1976-1980 Phase 3 (E-switch-ic) Estramustine Seems not superior
Osborne et al. 1990 (SWOG S8219) 1982-1986 Phase 3 (C) AC & Orchiectomy Seems not superior
Waymont et al. 1992 1985-1987 Phase 3 (C) Goserelin Seems to have inferior TTFR

Note: No longer used, but of historical interest.

Endocrine therapy

Continued indefintely

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 contains dosing details in abstract PubMed

Chemotherapy for metastatic disease

CMF

CMF: Cyclophosphamide, Methotrexate, 5-Fluorouracil

Regimen

Study Evidence
Wozniak et al. 1993 Phase 2

Note: 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 dosing details in manuscript PubMed

Suramin monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Small et al. 2002 (CALGB 9480) 1995-12 to 1996-12 Phase 3 (C) 1. Suramin; intermediate-dose
2. Suramin; high-dose 		Did not meet primary endpoint of RR

Chemotherapy

  • Suramin (Antrypol) as follows:
    • Cycle 1: 600 mg/m2 IV once on day 1, then 300 mg/m2 IV once per day on days 2 & 8, then 240 mg/m2 IV once on day 9
    • Cycle 2: 300 mg/m2 IV once on day 1, then 240 mg/m2 IV once per day on days 2 & 8, then 192 mg/m2 IV once on day 9
    • Cycle 3: 240 mg/m2 IV once on day 1, then 192 mg/m2 IV once per day on days 2 & 8, then 156 mg/m2 IV once on day 9

28-day cycle for 3 cycles

References

  1. CALGB 9480: Small EJ, Halabi S, Ratain MJ, Rosner G, Stadler W, Palchak D, Marshall E, Rago R, Hars V, Wilding G, Petrylak D, Vogelzang NJ. Randomized study of three different doses of suramin administered with a fixed dosing schedule in patients with advanced prostate cancer: results of intergroup 0159, cancer and leukemia group B 9480. J Clin Oncol. 2002 Aug 15;20(16):3369-75. link to original article contains dosing details in manuscript PubMed NCT00002723

Suramin & Hydrocortisone

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Small et al. 2000 1994-1996 Phase 3 (E-esc) Hydrocortisone Superior TTP (secondary endpoint)

Endocrine therapy

Chemotherapy

  • Suramin (Antrypol) 1000 mg/m2 IV over 2 hours once on day 1, then 400 mg/m2 IV over 60 minutes once on day 2, then 300 mg/m2 IV over 60 minutes once on day 3, then 250 mg/m2 IV over 60 minutes once on day 4, then 200 mg/m2 IV over 60 minutes once on day 5, then 275 mg/m2 IV over 60 minutes once per day on days 8, 11, 15, 19, 22, 29, 36, 43, 50, 57, 64, 71, 78

78-day course

References

  1. Small EJ, Meyer M, Marshall ME, Reyno LM, Meyers FJ, Natale RB, Lenehan PF, Chen L, Slichenmyer WJ, Eisenberger M. Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone. J Clin Oncol. 2000 Apr;18(7):1440-50. link to original article contains dosing details in manuscript PubMed

Therapy for metastatic castrate-resistant disease

Aspirin & Dexamethasone

DA: Dexamethasone & Aspirin

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Shamash et al. 2011 (BARTS-DAVDAS) 2001-2008 Phase 3 (C) Aspirin, Dexamethasone, Diethylstilbestrol Seems not superior

Endocrine therapy

Supportive therapy

Continued indefinitely

References

  1. BARTS-DAVDAS: 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 contains dosing details in manuscript PubMed NCT00316927

Cyclophosphamide monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Saxman et al. 1992 1984-1989 Phase 3 (C) CAM Seems not superior

Chemotherapy

21-day cycles

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 contains dosing details in manuscript PubMed

Cyclophosphamide, Prednisone, Diethylstilbestrol

CPD: Cyclophosphamide, Prednisone, Diethylstilbestrol

Regimen

Study Evidence Efficacy
Hellerstedt et al. 2003 Phase 2 50% or greater decline in PSA: 42%

Chemotherapy

Endocrine therapy

Supportive therapy

30-day cycles

References

  1. 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 dosing details in manuscript PubMed

Doxorubicin monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Leaf et al. 2003 (ECOG E3882) 1983-1986 Phase 3 (C) Doxorubicin & DES Seems not superior
Tu et al. 2001 1996-1999 Randomized Phase 2 (C) Doxorubicin & Strontium-89 Inferior OS

Chemotherapy

21-day cycles

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 contains dosing details in manuscript PubMed

Doxorubicin & Strontium-89

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Tu et al. 2001 1996-1999 Randomized Phase 2 (E-esc) Doxorubicin Superior OS

Preceding treatment

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

Vinblastine monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Hudes et al. 1999 1993-1995 Phase 3 (C) Estramustine & Vinblastine Might have inferior OS

Chemotherapy

8-week cycles

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 contains dosing details in abstract' PubMed
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