Difference between revisions of "Prostate cancer - null regimens"
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
− | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Prostate cancer|main prostate cancer page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
Line 9: | Line 9: | ||
=Neoadjuvant therapy= | =Neoadjuvant therapy= | ||
==No neoadjuvant therapy== | ==No neoadjuvant therapy== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 21: | Line 21: | ||
|2006-2015 | |2006-2015 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[#ADT_. | + | |[[#ADT_.26_Docetaxel_999|ADT & Docetaxel]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of BPFS | | style="background-color:#ffffbf" |Did not meet primary endpoint of BPFS | ||
|- | |- | ||
|} | |} | ||
''No treatment prior to surgical resection.'' | ''No treatment prior to surgical resection.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
*[[Surgery#Radical_prostatectomy|Radical prostatectomy]] | *[[Surgery#Radical_prostatectomy|Radical prostatectomy]] | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | #'''CALGB 90203:''' Eastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, Morris MJ. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer. J Clin Oncol. 2020 Sep 10;38(26):3042-3050. Epub 2020 Jul 24. [https://doi.org/10.1200/jco.20.00315 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7479762/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32706639 PubMed] NCT00430183 | + | #'''CALGB 90203:''' Eastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, Morris MJ. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer. J Clin Oncol. 2020 Sep 10;38(26):3042-3050. Epub 2020 Jul 24. [https://doi.org/10.1200/jco.20.00315 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7479762/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32706639/ PubMed] [https://clinicaltrials.gov/study/NCT00430183 NCT00430183] |
=Adjuvant therapy= | =Adjuvant therapy= | ||
==Observation== | ==Observation== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 45: | Line 47: | ||
|1988-1993 | |1988-1993 | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | | | + | |1a. [[#Castration_888|Bilateral orchiectomy]]<br>1b. [[Prostate_cancer#Goserelin_monotherapy|Goserelin]] |
|style="background-color:#fc8d59"|Seems to have inferior OS | |style="background-color:#fc8d59"|Seems to have inferior OS | ||
|- | |- | ||
Line 57: | Line 59: | ||
|2005-2007 | |2005-2007 | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |1. [[#Docetaxel_. | + | |1. [[#Docetaxel_.26_Leuprolide_999|Docetaxel & Leuprolide]]<br>2. [[#Leuprolide_monotherapy_999|Leuprolide]] |
| style="background-color:#d3d3d3" |Not reported | | style="background-color:#d3d3d3" |Not reported | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/j.eururo.2018.01.012 Ahlgren et al. 2018 (SPCG 12)] |
|2005-2010 | |2005-2010 | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |[[# | + | |[[#Docetaxel_monotherapy_999|Docetaxel]] |
| style="background-color:#d9ef8b" |Might have superior OS | | style="background-color:#d9ef8b" |Might have superior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/j.eururo.2019.12.020 Lin et al. 2020 (VA 553)] | ||
+ | |2006-07 to 2011-10 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[#Docetaxel_.26_Prednisone_999|Docetaxel & Prednisone]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | ||
|- | |- | ||
|[https://doi.org/10.1016/j.eururo.2019.08.010 Kellokumpu-Lehtinen et al. 2019 (SPCG-13)] | |[https://doi.org/10.1016/j.eururo.2019.08.010 Kellokumpu-Lehtinen et al. 2019 (SPCG-13)] | ||
− | | | + | |2007-05 to 2012-08 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |[[# | + | |[[#Docetaxel_monotherapy_999|Docetaxel]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of BDFS | | style="background-color:#ffffbf" |Did not meet primary endpoint of BDFS | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy of RTOG 92-02 is based on the 2017 update.''<br> | ''<sup>1</sup>Reported efficacy of RTOG 92-02 is based on the 2017 update.''<br> | ||
''Note: TAX-3501 was closed early due to poor accrual, and statistical comparisons were not made. No further treatment after definitive therapy'' | ''Note: TAX-3501 was closed early due to poor accrual, and statistical comparisons were not made. No further treatment after definitive therapy'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*ECOG E3886, TAX-3501, SPCG 12, VA 553: [[Surgery#Radical_prostatectomy|Radical prostatectomy]] | *ECOG E3886, TAX-3501, SPCG 12, VA 553: [[Surgery#Radical_prostatectomy|Radical prostatectomy]] | ||
− | *RTOG 92-02: [[Prostate_cancer#Flutamide.2C_Goserelin.2C_RT|Flutamide, Goserelin, RT]] | + | *RTOG 92-02: Definitive [[Prostate_cancer#Flutamide.2C_Goserelin.2C_RT|Flutamide, Goserelin, RT]] |
− | *SPCG-13: [[Prostate_cancer_-_historical#Radiation_therapy|Radiotherapy]] | + | *SPCG-13: Definitive [[Prostate_cancer_-_historical#Radiation_therapy|Radiotherapy]] |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | # '''ECOG E3886:''' Messing EM, Manola J, Sarosdy M, Wilding G, Crawford ED, Trump D; [[Study_Groups#ECOG|ECOG]]. 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. [https://doi.org/10.1056/NEJM199912093412401 link to original article] | + | # '''ECOG E3886:''' Messing EM, Manola J, Sarosdy M, Wilding G, Crawford ED, Trump D; [[Study_Groups#ECOG|ECOG]]. 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. [https://doi.org/10.1056/NEJM199912093412401 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10588962/ PubMed] |
− | ## '''Update:''' Messing EM, Manola J, Yao J, Kiernan M, Crawford D, Wilding G, di'SantAgnese PA, Trump D; [[Study_Groups#ECOG|ECOG]]. 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. [https://doi.org/10.1016/S1470-2045(06)70700-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16750497 PubMed] | + | ## '''Update:''' Messing EM, Manola J, Yao J, Kiernan M, Crawford D, Wilding G, di'SantAgnese PA, Trump D; [[Study_Groups#ECOG|ECOG]]. 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. [https://doi.org/10.1016/S1470-2045(06)70700-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16750497/ PubMed] |
− | # '''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. [https://doi.org/10.1200/jco.2003.11.023 link to original article] | + | # '''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. [https://doi.org/10.1200/jco.2003.11.023 link to original article] [https://pubmed.ncbi.nlm.nih.gov/14581419/ PubMed] |
− | ## '''Update:''' Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. [https://doi.org/10.1200/jco.2007.14.9021 link to original article] | + | ## '''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. [https://doi.org/10.1200/jco.2007.14.9021 link to original article] [https://pubmed.ncbi.nlm.nih.gov/18413638/ PubMed] |
− | ##'''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. [https://doi.org/10.1016/j.ijrobp.2017.02.004 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5603177/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28463149 PubMed] | + | ##'''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. [https://doi.org/10.1016/j.ijrobp.2017.02.004 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5603177/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28463149/ PubMed] |
− | # '''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. [https://doi.org | + | # '''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. [https://doi.org/10.1002/cncr.28270 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4124610/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23943299/ PubMed] [https://clinicaltrials.gov/study/NCT00283062 NCT00283062] |
− | # '''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. [https:// | + | # '''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. [https://doi.org/10.1016/j.eururo.2018.01.012 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29395502/ PubMed] [https://clinicaltrials.gov/study/NCT00376792 NCT00376792] |
− | # '''SPCG-13:''' Kellokumpu-Lehtinen PL, Hjälm-Eriksson M, Thellenberg-Karlsson C, Åström L, Franzen L, Fransson AS, Leskinen MJ, | + | # '''SPCG-13:''' Kellokumpu-Lehtinen PL, Hjälm-Eriksson M, Thellenberg-Karlsson C, Åström L, Franzen L, Fransson AS, Leskinen MJ, Seke M, Huttunen T, Ginman C; Scandinavian Prostate Cancer Group. Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial. Eur Urol. 2019 Dec;76(6):823-830. Epub 2019 Aug 20. Erratum in: Eur Urol. 2020 Dec;78(6):e241-e242. [https://doi.org/10.1016/j.eururo.2019.08.010 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31443961/ PubMed] [https://clinicaltrials.gov/study/NCT00653848 NCT00653848] |
− | # '''VA 553:''' Lin DW, Shih MC, Aronson W, Basler J, Beer TM, Brophy M, Cooperberg M, Garzotto M, Kelly WK, Lee K, McGuire V, Wang Y, Lu Y, Markle V, Nseyo U, Ringer R, Savage SJ, Sinnott P, Uchio E, Yang CC, Montgomery RB. Veterans Affairs Cooperative Studies Program Study #553: Chemotherapy After Prostatectomy for High-risk Prostate Carcinoma: A Phase III Randomized Study. Eur Urol. 2020 May;77(5):563-572. Epub 2020 Jan 8. [https://doi.org/10.1016/j.eururo.2019.12.020 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31924316/ PubMed] NCT00132301 | + | # '''VA 553:''' Lin DW, Shih MC, Aronson W, Basler J, Beer TM, Brophy M, Cooperberg M, Garzotto M, Kelly WK, Lee K, McGuire V, Wang Y, Lu Y, Markle V, Nseyo U, Ringer R, Savage SJ, Sinnott P, Uchio E, Yang CC, Montgomery RB. Veterans Affairs Cooperative Studies Program Study #553: Chemotherapy After Prostatectomy for High-risk Prostate Carcinoma: A Phase III Randomized Study. Eur Urol. 2020 May;77(5):563-572. Epub 2020 Jan 8. [https://doi.org/10.1016/j.eururo.2019.12.020 link to original article] [https://pubmed.ncbi.nlm.nih.gov/31924316/ PubMed] [https://clinicaltrials.gov/study/NCT00132301 NCT00132301] |
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 110: | Line 113: | ||
|1997-2010 | |1997-2010 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Soy_protein_isolate_999|Soy protein isolate]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of biochemical recurrence rate | | style="background-color:#ffffbf" |Did not meet primary endpoint of biochemical recurrence rate | ||
|- | |- | ||
|} | |} | ||
''No further treatment after definitive therapy'' | ''No further treatment after definitive therapy'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*[[Surgery#Radical_prostatectomy|Radical prostatectomy]] | *[[Surgery#Radical_prostatectomy|Radical prostatectomy]] | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # '''UIC-2006-0706:''' 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. [https://jamanetwork.com/journals/jama/fullarticle/1710457 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921119/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23839751 PubMed] NCT00765479 | + | # '''UIC-2006-0706:''' 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. [https://jamanetwork.com/journals/jama/fullarticle/1710457 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921119/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23839751/ PubMed] [https://clinicaltrials.gov/study/NCT00765479 NCT00765479] |
=Therapy for non-metastatic castrate resistant disease= | =Therapy for non-metastatic castrate resistant disease= | ||
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 134: | Line 139: | ||
|2001-2003 | |2001-2003 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Atrasentan_monotherapy_999|Atrasentan]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of TTP | | style="background-color:#ffffbf" |Did not meet primary endpoint of TTP | ||
|- | |- | ||
Line 140: | Line 145: | ||
|2008-2011 | |2008-2011 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Zibotentan_monotherapy_999|Zibotentan]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
|} | |} | ||
''No active antineoplastic therapy.'' | ''No active antineoplastic therapy.'' | ||
+ | </div> | ||
===References=== | ===References=== | ||
− | # '''M00-244:''' 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. [https://doi.org | + | # '''M00-244:''' 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. [https://doi.org/10.1002/cncr.23864 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3085548/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18785254/ PubMed] [https://clinicaltrials.gov/study/NCT00036556 NCT00036556] |
− | # '''ENTHUSE M0:''' 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. [https://www.nature.com/articles/pcan20132 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23381694 PubMed] NCT00626548 | + | # '''ENTHUSE M0:''' 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. [https://www.nature.com/articles/pcan20132 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23381694/ PubMed] [https://clinicaltrials.gov/study/NCT00626548 NCT00626548] |
=Therapy for metastatic castrate-resistant disease= | =Therapy for metastatic castrate-resistant disease= | ||
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 17%"|Study | !style="width: 17%"|Study | ||
− | !style="width: 15%"| | + | !style="width: 15%"|Dates of enrollment |
!style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 17%"|Comparator | !style="width: 17%"|Comparator | ||
Line 161: | Line 167: | ||
!style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | !style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | ||
|- | |- | ||
− | |[https://doi.org/ | + | |[https://doi.org/10.1200/JCO.2005.04.5252 Small et al. 2006 (D9901)] |
− | |2001-2002 | + | |2000-01 to 2001-10 |
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[Prostate_cancer#Sipuleucel-T_monotherapy|Sipuleucel-T]] | ||
+ | | style="background-color:#fee08b" |Might have inferior TTP | ||
+ | | | ||
+ | |- | ||
+ | |[https://doi.org/10.1002/cncr.22996 Carducci et al. 2007] | ||
+ | |2001-06-25 to 2002-11-25 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Atrasentan_monotherapy_999|Atrasentan]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of TTP | | style="background-color:#ffffbf" |Did not meet primary endpoint of TTP | ||
| | | | ||
Line 182: | Line 195: | ||
| | | | ||
|- | |- | ||
− | |[https://doi.org | + | |[https://doi.org/10.1002/cncr.27674 Nelson et al. 2012 (ENTHUSE M1)] |
|2007-2009 | |2007-2009 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Zibotentan_monotherapy_999|Zibotentan]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| | | | ||
Line 197: | Line 210: | ||
|- | |- | ||
|[https://doi.org/10.1056/NEJMoa1207506 Scher et al. 2012 (AFFIRM)] | |[https://doi.org/10.1056/NEJMoa1207506 Scher et al. 2012 (AFFIRM)] | ||
− | |2009-2010 | + | |2009-09 to 2010-11 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
|[[Prostate_cancer#Enzalutamide_monotherapy|Enzalutamide]] | |[[Prostate_cancer#Enzalutamide_monotherapy|Enzalutamide]] | ||
Line 206: | Line 219: | ||
|2009-2012 | |2009-2012 | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |[[# | + | |[[#Ipilimumab_monotherapy_333|Ipilimumab]] |
|style="background-color:#fee08b"|Might have inferior OS | |style="background-color:#fee08b"|Might have inferior OS | ||
| | | | ||
Line 220: | Line 233: | ||
|2010-NR | |2010-NR | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |[[# | + | |[[#Ipilimumab_monotherapy_999|Ipilimumab]] |
− | |style="background-color:#ffffbf"| | + | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS |
| | | | ||
|- | |- | ||
|[https://doi.org/10.1200/JCO.2016.66.9697 Sternberg et al. 2016 (10TASQ10)] | |[https://doi.org/10.1200/JCO.2016.66.9697 Sternberg et al. 2016 (10TASQ10)] | ||
− | |2011-2012 | + | |2011-03-29 to 2012-12-07 |
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Tasquinimod_monotherapy_777|Tasquinimod]] |
| style="background-color:#d73027" |Inferior rPFS | | style="background-color:#d73027" |Inferior rPFS | ||
| | | | ||
Line 234: | Line 247: | ||
|2011-2015 | |2011-2015 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |1. [[# | + | |1. [[#PROSTVAC_monotherapy_999|PROSTVAC]]<br>2. [[#PROSTVAC_.26_GM-CSF_999|PROSTVAC & GM-CSF]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
| | | | ||
Line 241: | Line 254: | ||
|2013-2016 | |2013-2016 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
− | |[[# | + | |[[#Personalized_peptide_vaccine_999|Personalized peptide vaccine]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
+ | | | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9123068/ Pu et al. 2022 (9785-CL-0232)] | ||
+ | |2014-04-23 to 2015-09-20 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[Prostate_cancer#Enzalutamide_monotherapy|Enzalutamide]] | ||
+ | | style="background-color:#d73027" |Inferior OS/time to PSA progression | ||
| | | | ||
|- | |- | ||
|} | |} | ||
''No active antineoplastic therapy.'' | ''No active antineoplastic therapy.'' | ||
+ | </div> | ||
+ | |||
===References=== | ===References=== | ||
− | # '''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. [https://doi.org/10.1200/JCO.2005.04.5252 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16809734 PubMed] | + | # '''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. [https://doi.org/10.1200/JCO.2005.04.5252 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16809734/ PubMed] |
− | ## '''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. [https://doi.org | + | ## '''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. [https://doi.org/10.1002/cncr.24429 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19536890/ PubMed] |
− | # 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. [https://doi.org/10.1016/S1470-2045(07)70147-X link to original article] | + | # 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. [https://doi.org/10.1016/S1470-2045(07)70147-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/17544845/ PubMed] |
− | ## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [ | + | ## '''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. [https://doi.org/10.1016/j.clgc.2012.07.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23021204/ PubMed] |
− | # 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. [https://doi.org | + | # 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. [https://doi.org/10.1002/cncr.22996 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17886253/ PubMed] |
− | # '''IMPACT<sub>prostate</sub>:''' 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. [https://doi.org/10.1056/NEJMoa1001294 link to original article] | + | # '''IMPACT<sub>prostate</sub>:''' 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. [https://doi.org/10.1056/NEJMoa1001294 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20818862/ PubMed] [https://clinicaltrials.gov/study/NCT00065442 NCT00065442] |
− | # '''ENTHUSE M1:''' 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. [https://doi.org | + | # '''ENTHUSE M1:''' 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. [https://doi.org/10.1002/cncr.27674 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22786751/ PubMed] [https://clinicaltrials.gov/study/NCT00554229 NCT00554229] |
− | # '''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. [https://doi.org/10.1056/NEJMoa1207506 link to original article] | + | # '''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. [https://doi.org/10.1056/NEJMoa1207506 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22894553/ PubMed] [https://clinicaltrials.gov/study/NCT00974311 NCT00974311] |
<!-- | <!-- | ||
# Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session] | # Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session] | ||
Line 261: | Line 283: | ||
# Nicholas J. Vogelzang, Chris Parker, Sten Nilsson, Robert Edward Coleman, C. Gillies O'Bryan-Tear, Minghua Shan, A. Oliver Sartor. Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA). 2013 ASCO Genitourinary Cancers Symposium Abstract 11. [https://meetinglibrary.asco.org/content/107117-134 link to abstract] | # Nicholas J. Vogelzang, Chris Parker, Sten Nilsson, Robert Edward Coleman, C. Gillies O'Bryan-Tear, Minghua Shan, A. Oliver Sartor. Updated analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase III randomized trial (ALSYMPCA). 2013 ASCO Genitourinary Cancers Symposium Abstract 11. [https://meetinglibrary.asco.org/content/107117-134 link to abstract] | ||
# Sten Nilsson, A. Oliver Sartor, Oyvind S. Bruland, Fang Fang, Anne-Kirsti Aksnes, Chris Parker. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. 2013 ASCO Genitourinary Cancers Symposium Abstract 19. [http://meetinglibrary.asco.org/content/107297-134 link to abstract] | # Sten Nilsson, A. Oliver Sartor, Oyvind S. Bruland, Fang Fang, Anne-Kirsti Aksnes, Chris Parker. Pain analysis from the phase III randomized ALSYMPCA study with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases. 2013 ASCO Genitourinary Cancers Symposium Abstract 19. [http://meetinglibrary.asco.org/content/107297-134 link to abstract] | ||
− | # '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [ | + | # '''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. [https://doi.org/10.1016/j.clgc.2012.07.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23021204/ PubMed] |
--> | --> | ||
− | # '''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. [https://doi.org/10.1056/NEJMoa1213755 link to original article] | + | # '''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. [https://doi.org/10.1056/NEJMoa1213755 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23863050/ PubMed] [https://clinicaltrials.gov/study/NCT00699751 NCT00699751] |
− | ## '''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. [https://doi.org/10.1016/S1470-2045(14)70183-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24836273 PubMed] | + | ## '''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. [https://doi.org/10.1016/S1470-2045(14)70183-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24836273/ PubMed] |
− | ## '''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. [https://doi.org/10.1016/S1470-2045%2814%2970474-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25439694 PubMed] | + | ## '''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. [https://doi.org/10.1016/S1470-2045%2814%2970474-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25439694/ PubMed] |
− | ## '''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. [https://doi.org/10.1093/annonc/mdw065 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4843190/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26912557 PubMed] | + | ## '''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. [https://doi.org/10.1093/annonc/mdw065 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4843190/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26912557/ PubMed] |
− | # '''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. [https://doi.org/10.1016/S1470-2045(14)70189-5 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418935/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24831977 PubMed] | + | # '''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. [https://doi.org/10.1016/S1470-2045(14)70189-5 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418935/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24831977/ PubMed] [https://clinicaltrials.gov/study/NCT00861614 NCT00861614] |
− | + | ##'''Update:''' Fizazi K, Drake CG, Beer TM, Kwon ED, Scher HI, Gerritsen WR, Bossi A, den Eertwegh AJMV, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Danielli R, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, McHenry MB, Chen A, Logothetis C; CA184-043 Investigators. Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors. Eur Urol. 2020 Dec;78(6):822-830. Epub 2020 Aug 15. [https://doi.org/10.1016/j.eururo.2020.07.032 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8428575/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32811715/ PubMed] | |
− | + | <!-- # Beer TM, Armstrong AJ, Sternberg CN, Higano CS, Iversen P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. ASCO Meeting Abstracts. 2014 February 5, 2014;32(4_suppl):LBA1. [http://abstracts.asco.org/142/AbstView_142_123836.html link to original article] --> | |
− | # '''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. [https://doi.org/10.1056/NEJMoa1405095 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418931/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24881730 PubMed] | + | # '''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. [https://doi.org/10.1056/NEJMoa1405095 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418931/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24881730/ PubMed] [https://clinicaltrials.gov/study/NCT01212991 NCT01212991] |
− | + | ##'''HRQoL analysis:''' Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015 May;16(5):509-21. Epub 2015 Apr 14. [https://doi.org/10.1016/s1470-2045(15)70113-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25888263/ PubMed] | |
− | ## ''' | + | ## '''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. [https://doi.org/10.1016/j.eururo.2016.07.032 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5570461/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27477525/ PubMed] |
− | # ''' | + | ## '''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. [https://hqlo.biomedcentral.com/articles/10.1186/s12955-017-0704-y link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481866/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28645287/ PubMed] |
− | # ''' | + | ##'''Update:''' Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. Epub 2020 Jun 9. [https://doi.org/10.1016/j.eururo.2020.04.061 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32527692/ PubMed] |
− | # ''' | + | # '''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. [https://doi.org/10.1200/JCO.2016.66.9697 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27298414/ PubMed] [https://clinicaltrials.gov/study/NCT01234311 NCT01234311] |
− | # | + | # '''CA184-095:''' 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. [https://doi.org/10.1200/JCO.2016.69.1584 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28034081/ PubMed] [https://clinicaltrials.gov/study/NCT01057810 NCT01057810] |
+ | # '''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. [https://doi.org/10.1200/JCO.18.02031 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6494360/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30817251/ PubMed] [https://clinicaltrials.gov/study/NCT01322490 NCT01322490] | ||
+ | #Noguchi M, Fujimoto K, Arai G, Uemura H, Hashine K, Matsumoto H, Fukasawa S, Kohjimoto Y, Nakatsu H, Takenaka A, Fujisawa M, Uemura H, Naito S, Egawa S, Fujimoto H, Hinotsu S, Itoh K. A randomized phase III trial of personalized peptide vaccination for castration-resistant prostate cancer progressing after docetaxel. Oncol Rep. 2021 Jan;45(1):159-168. Epub 2020 Nov 11. [https://doi.org/10.3892/or.2020.7847 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7709822/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33200227/ PubMed] UMIN000011308 | ||
+ | #'''9785-CL-0232:''' Pu YS, Ahn H, Han W, Huang SP, Wu HC, Ma L, Yamada S, Suga K, Xie LP. Enzalutamide in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: An Asian Multiregional, Randomized Study. Adv Ther. 2022 Jun;39(6):2641-2656. Epub 2022 Apr 10. [https://doi.org/10.1007/s12325-022-02140-2 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9123068/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35397772/ PubMed] [https://clinicaltrials.gov/study/NCT02294461 NCT02294461] | ||
[[Category:Prostate cancer regimens]] | [[Category:Prostate cancer regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
− | [[Category: | + | [[Category:Male genital cancers]] |
[[Category:Null regimens]] | [[Category:Null regimens]] |
Latest revision as of 15:13, 6 May 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main prostate cancer page for regimens that include active anticancer treatment.
Neoadjuvant therapy
No neoadjuvant therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Eastham et al. 2020 (CALGB 90203) | 2006-2015 | Phase 3 (C) | ADT & Docetaxel | Did not meet primary endpoint of BPFS |
No treatment prior to surgical resection.
Subsequent treatment
References
- CALGB 90203: Eastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, Morris MJ. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer. J Clin Oncol. 2020 Sep 10;38(26):3042-3050. Epub 2020 Jul 24. link to original article link to PMC article PubMed NCT00430183
Adjuvant therapy
Observation
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Messing et al. 1999 (ECOG E3886) | 1988-1993 | Phase 3 (C) | 1a. Bilateral orchiectomy 1b. Goserelin |
Seems to have inferior OS |
Hanks et al. 2003 (RTOG 92-02) | 1992-1995 | Phase 3 (C) | Goserelin | Seems to have inferior OS1 |
Schweizer et al. 2013 (TAX-3501) | 2005-2007 | Phase 3 (C) | 1. Docetaxel & Leuprolide 2. Leuprolide |
Not reported |
Ahlgren et al. 2018 (SPCG 12) | 2005-2010 | Phase 3 (C) | Docetaxel | Might have superior OS |
Lin et al. 2020 (VA 553) | 2006-07 to 2011-10 | Phase 3 (C) | Docetaxel & Prednisone | Did not meet primary endpoint of PFS |
Kellokumpu-Lehtinen et al. 2019 (SPCG-13) | 2007-05 to 2012-08 | Phase 3 (C) | Docetaxel | Did not meet primary endpoint of BDFS |
1Reported efficacy of RTOG 92-02 is based on the 2017 update.
Note: TAX-3501 was closed early due to poor accrual, and statistical comparisons were not made. No further treatment after definitive therapy
Preceding treatment
- ECOG E3886, TAX-3501, SPCG 12, VA 553: Radical prostatectomy
- RTOG 92-02: Definitive Flutamide, Goserelin, RT
- SPCG-13: Definitive Radiotherapy
References
- ECOG E3886: Messing EM, Manola J, Sarosdy M, Wilding G, Crawford ED, Trump D; ECOG. 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 PubMed
- Update: Messing EM, Manola J, Yao J, Kiernan M, Crawford D, Wilding G, di'SantAgnese PA, Trump D; ECOG. 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
- 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 PubMed
- Update: Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. Epub 2008 Apr 14. link to original article PubMed
- 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. link to original article link to PMC article PubMed
- 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 NCT00283062
- 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 NCT00376792
- SPCG-13: Kellokumpu-Lehtinen PL, Hjälm-Eriksson M, Thellenberg-Karlsson C, Åström L, Franzen L, Fransson AS, Leskinen MJ, Seke M, Huttunen T, Ginman C; Scandinavian Prostate Cancer Group. Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial. Eur Urol. 2019 Dec;76(6):823-830. Epub 2019 Aug 20. Erratum in: Eur Urol. 2020 Dec;78(6):e241-e242. link to original article PubMed NCT00653848
- VA 553: Lin DW, Shih MC, Aronson W, Basler J, Beer TM, Brophy M, Cooperberg M, Garzotto M, Kelly WK, Lee K, McGuire V, Wang Y, Lu Y, Markle V, Nseyo U, Ringer R, Savage SJ, Sinnott P, Uchio E, Yang CC, Montgomery RB. Veterans Affairs Cooperative Studies Program Study #553: Chemotherapy After Prostatectomy for High-risk Prostate Carcinoma: A Phase III Randomized Study. Eur Urol. 2020 May;77(5):563-572. Epub 2020 Jan 8. link to original article PubMed NCT00132301
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bosland et al. 2013 (UIC-2006-0706) | 1997-2010 | Phase 3 (C) | Soy protein isolate | Did not meet primary endpoint of biochemical recurrence rate |
No further treatment after definitive therapy
Preceding treatment
References
- UIC-2006-0706: 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 NCT00765479
Therapy for non-metastatic castrate resistant disease
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nelson et al. 2008 (M00-244) | 2001-2003 | Phase 3 (C) | Atrasentan | Did not meet primary endpoint of TTP |
Miller et al. 2013 (ENTHUSE M0) | 2008-2011 | Phase 3 (C) | Zibotentan | Did not meet primary endpoint of OS |
No active antineoplastic therapy.
References
- M00-244: 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 NCT00036556
- ENTHUSE M0: 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 NCT00626548
Therapy for metastatic castrate-resistant disease
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
---|---|---|---|---|---|
Small et al. 2006 (D9901) | 2000-01 to 2001-10 | Phase 3 (C) | Sipuleucel-T | Might have inferior TTP | |
Carducci et al. 2007 | 2001-06-25 to 2002-11-25 | Phase 3 (C) | Atrasentan | Did not meet primary endpoint of TTP | |
Kantoff et al. 2010 (IMPACTprostate) | 2003-2007 | Phase 3 (C) | Sipuleucel-T | Seems to have inferior OS | |
Nilsson et al. 2007 | 2004-2005 | Randomized Phase 2 (C) | Radium-223 | Might have inferior OS | |
Nelson et al. 2012 (ENTHUSE M1) | 2007-2009 | Phase 3 (C) | Zibotentan | Did not meet primary endpoint of OS | |
Parker et al. 2013 (ALSYMPCA) | 2008-2011 | Phase 3 (C) | Radium-223 | Inferior OS | Inferior EQ-5D score |
Scher et al. 2012 (AFFIRM) | 2009-09 to 2010-11 | Phase 3 (C) | Enzalutamide | Inferior OS | |
Kwon et al. 2014 (CA184-043) | 2009-2012 | Phase 3 (C) | Ipilimumab | Might have inferior OS | |
Beer et al. 2014 (PREVAIL) | 2010-2012 | Phase 3 (C) | Enzalutamide | Inferior OS | Worse HRQoL |
Beer et al. 2016 (CA184-095) | 2010-NR | Phase 3 (C) | Ipilimumab | Did not meet primary endpoint of OS | |
Sternberg et al. 2016 (10TASQ10) | 2011-03-29 to 2012-12-07 | Phase 3 (C) | Tasquinimod | Inferior rPFS | |
Gulley et al. 2019 (PROSPECT) | 2011-2015 | Phase 3 (C) | 1. PROSTVAC 2. PROSTVAC & GM-CSF |
Did not meet primary endpoint of OS | |
Noguchi et al. 2020 | 2013-2016 | Phase 3 (C) | Personalized peptide vaccine | Did not meet primary endpoint of OS | |
Pu et al. 2022 (9785-CL-0232) | 2014-04-23 to 2015-09-20 | Phase 3 (C) | Enzalutamide | Inferior OS/time to PSA progression |
No active antineoplastic therapy.
References
- 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
- 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
- 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 PubMed
- Update: Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. link to original article PubMed
- 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
- IMPACTprostate: 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 PubMed NCT00065442
- ENTHUSE M1: 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 NCT00554229
- 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 PubMed NCT00974311
- 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 PubMed NCT00699751
- 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
- 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
- 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
- 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 NCT00861614
- Update: Fizazi K, Drake CG, Beer TM, Kwon ED, Scher HI, Gerritsen WR, Bossi A, den Eertwegh AJMV, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Danielli R, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, McHenry MB, Chen A, Logothetis C; CA184-043 Investigators. Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors. Eur Urol. 2020 Dec;78(6):822-830. Epub 2020 Aug 15. link to original article link to PMC article PubMed
- 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 NCT01212991
- HRQoL analysis: Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015 May;16(5):509-21. Epub 2015 Apr 14. link to original article PubMed
- 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
- 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
- Update: Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. Epub 2020 Jun 9. link to original article PubMed
- 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 NCT01234311
- CA184-095: 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 NCT01057810
- 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 NCT01322490
- Noguchi M, Fujimoto K, Arai G, Uemura H, Hashine K, Matsumoto H, Fukasawa S, Kohjimoto Y, Nakatsu H, Takenaka A, Fujisawa M, Uemura H, Naito S, Egawa S, Fujimoto H, Hinotsu S, Itoh K. A randomized phase III trial of personalized peptide vaccination for castration-resistant prostate cancer progressing after docetaxel. Oncol Rep. 2021 Jan;45(1):159-168. Epub 2020 Nov 11. link to original article link to PMC article PubMed UMIN000011308
- 9785-CL-0232: Pu YS, Ahn H, Han W, Huang SP, Wu HC, Ma L, Yamada S, Suga K, Xie LP. Enzalutamide in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: An Asian Multiregional, Randomized Study. Adv Ther. 2022 Jun;39(6):2641-2656. Epub 2022 Apr 10. link to original article link to PMC article PubMed NCT02294461