Prostate cancer - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the main prostate cancer page for current regimens.


Adjuvant therapy

Observation

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Messing et al. 1999 (ECOG E3886) 1988-1993 Phase III (C) 1. Bilateral orchiectomy
2. Goserelin 		Seems to have inferior OS
Hanks et al. 2003 (RTOG 92-02) 1992-1995 Phase III (C) Goserelin Seems to have inferior OS (*)
Schweizer et al. 2013 (TAX-3501) 2005-2007 Phase III (C) 1. Docetaxel & Leuprolide
2. Leuprolide 		Not reported
Ahlgren et al. 2018 (SPCG 12) 2005-2010 Phase III (C) Docetaxel Might have superior OS

Note: TAX-3501 was closed early due to poor accrual, and statistical comparisons were not made. Reported efficacy of RTOG 92-02 is based on the 2017 update. No further treatment after definitive therapy

Preceding treatment

References

  1. ECOG E3886: Messing EM, Manola J, Sarosdy M, Wilding G, Crawford ED, Trump D; Eastern Cooperative Oncology Group. Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. N Engl J Med. 1999 Dec 9;341(24):1781-8. link to original article contains verified protocol PubMed
    1. Update: Messing EM, Manola J, Yao J, Kiernan M, Crawford D, Wilding G, di'SantAgnese PA, Trump D; Eastern Cooperative Oncology Group. Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol. 2006 Jun;7(6):472-9. link to original article PubMed
  2. RTOG 92-02: Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. Erratum in: J Clin Oncol. 2004 Jan 15;22(2):386. link to original article contains protocol PubMed
    1. Update: Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. link to original article contains verified protocol PubMed
    2. Update: Lawton CAF, Lin X, Hanks GE, Lepor H, Grignon DJ, Brereton HD, Bedi M, Rosenthal SA, Zeitzer KL, Venkatesan VM, Horwitz EM, Pisansky TM, Kim H, Parliament MB, Rabinovitch R, Roach M 3rd, Kwok Y, Dignam JJ, Sandler HM. Duration of androgen deprivation in locally advanced prostate cancer: long-term update of NRG Oncology RTOG 9202. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):296-303. Epub 2017 Feb 12. PubMed
  3. TAX-3501: Schweizer MT, Huang P, Kattan MW, Kibel AS, de Wit R, Sternberg CN, Epstein JI, Eisenberger MA. Adjuvant leuprolide with or without docetaxel in patients with high-risk prostate cancer after radical prostatectomy (TAX-3501): important lessons for future trials. Cancer. 2013 Oct 15;119(20):3610-8. Epub 2013 Aug 13. link to original article link to PMC article PubMed
  4. SPCG 12: Ahlgren GM, Flodgren P, Tammela TLJ, Kellokumpu-Lehtinen P, Borre M, Angelsen A, Iversen JR, Sverrisdottir A, Jonsson E, Sengelov L; Scandinavian Prostate Cancer Group. Docetaxel versus surveillance after radical prostatectomy for high-risk prostate cancer: results from the prospective randomised, open-label phase 3 Scandinavian Prostate Cancer Group 12 trial. Eur Urol. 2018 Jun;73(6):870-876. Epub 2018 Feb 1. link to original article PubMed

Placebo

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Bosland et al. 2013 1997-2010 Phase III (C) Soy protein isolate Did not meet primary endpoint of biochemical recurrence rate

No further treatment after definitive therapy

Preceding treatment

References

  1. Bosland MC, Kato I, Zeleniuch-Jacquotte A, Schmoll J, Enk Rueter E, Melamed J, Kong MX, Macias V, Kajdacsy-Balla A, Lumey LH, Xie H, Gao W, Walden P, Lepor H, Taneja SS, Randolph C, Schlicht MJ, Meserve-Watanabe H, Deaton RJ, Davies JA. Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy: a randomized trial. JAMA. 2013 Jul 10;310(2):170-8. link to original article link to PMC article PubMed

Therapy for non-metastatic castrate resistant disease

Placebo

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Nelson et al. 2008 2001-2003 Phase III (C) Atrasentan Did not meet primary endpoint of TTP
Miller et al. 2013 (ENTHUSE) 2008-2011 Phase III (C) Zibotentan Did not meet primary endpoint of OS

No active antineoplastic therapy.

References

  1. Nelson JB, Love W, Chin JL, Saad F, Schulman CC, Sleep DJ, Qian J, Steinberg J, Carducci M; Atrasentan Phase 3 Study Group. Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormone-refractory prostate cancer. Cancer. 2008 Nov 1;113(9):2478-87. link to original article link to PMC article PubMed
  2. ENTHUSE: Miller K, Moul JW, Gleave M, Fizazi K, Nelson JB, Morris T, Nathan FE, McIntosh S, Pemberton K, Higano CS. Phase III, randomized, placebo-controlled study of once-daily oral zibotentan (ZD4054) in patients with non-metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2013 Jun;16(2):187-92. Epub 2013 Feb 5. link to original article PubMed

Therapy for metastatic castrate-resistant disease

Placebo

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Carducci et al. 2007 2001-2002 Phase III (C) Atrasentan Did not meet primary endpoint of TTP
Nelson et al. 2012 2007-2009 Phase III (C) Zibotentan Did not meet primary endpoint of OS
Sternberg et al. 2016 (10TASQ10) 2011-2012 Phase III (C) Tasquinimod Inferior rPFS
Gulley et al. 2019 (PROSPECT) 2011-2015 Phase III (C) 1. PROSTVAC
2. PROSTVAC & GM-CSF 		Did not meet primary endpoint of OS

No active antineoplastic therapy.

References

  1. Carducci MA, Saad F, Abrahamsson PA, Dearnaley DP, Schulman CC, North SA, Sleep DJ, Isaacson JD, Nelson JB; Atrasentan Phase III Study Group Institutions. A phase 3 randomized controlled trial of the efficacy and safety of atrasentan in men with metastatic hormone-refractory prostate cancer. Cancer. 2007 Nov 1;110(9):1959-66. link to original article PubMed
  2. Nelson JB, Fizazi K, Miller K, Higano C, Moul JW, Akaza H, Morris T, McIntosh S, Pemberton K, Gleave M. Phase 3, randomized, placebo-controlled study of zibotentan (ZD4054) in patients with castration-resistant prostate cancer metastatic to bone. Cancer. 2012 Nov 15;118(22):5709-18. Epub 2012 Jul 11. link to original article PubMed
  3. 10TASQ10: Sternberg C, Armstrong A, Pili R, Ng S, Huddart R, Agarwal N, Khvorostenko D, Lyulko O, Brize A, Vogelzang N, Delva R, Harza M, Thanos A, James N, Werbrouck P, Bögemann M, Hutson T, Milecki P, Chowdhury S, Gallardo E, Schwartsmann G, Pouget JC, Baton F, Nederman T, Tuvesson H, Carducci M. Randomized, double-blind, placebo-controlled phase III study of tasquinimod in men with metastatic castration-resistant prostate cancer. J Clin Oncol. 2016 Aug 1;34(22):2636-43. Epub 2016 Jun 13. link to original article PubMed
  4. PROSPECT: Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III trial of PROSTVAC in asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. Epub 2019 Feb 28. link to original article link to PMC article PubMed
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