Prostate cancer, HRD-positive

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Last updated on 2024-09-06:8 regimens on this page
9 variants on this page
Note: this page has regimens which are specific to prostate cancer with homologous recombination deficiency (HRD), including those with germline or somatic BRCA1/2 mutations. Please see the main prostate cancer page for other regimens.
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==NCCN==
*NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Prostate Cancer.
=Metastatic castration-resistant=
==Abiraterone monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Fizazi et al. 2023 (TRITON3) 	2017-02-08 to 2022-02-02	Phase 3 (C)	Rucaparib 	Shorter PFSi (primary endpoint)Median PFSi: 6.4 vs 10.2 mo(HR 1.64, 95% CI 1.25-2.13)
de Bono et al. 2020 (PROfound)	2017-04 to 2018-11 	Phase 3 (C)	Olaparib 	Seems to have shorter OS1Median OS: 14.7 vs 19.1 mo(HR 1.45, 95% CI 1.03-2.00)Shorter rPFSMedian rPFS: 3.6 vs 7.4 mo(HR 2.94, 95% CI 2.13-4.00)
Chi et al. 2023 (MAGNITUDE) 	2019-05 to 2021-03 	Phase 3 (C)	Abiraterone & Niraparib	Shorter rPFS (primary endpoint)Median rPFS: 10.9 vs 16.6 mo(HR 1.89, 95% CI 1.27-2.78)
1Reported OS efficacy for PROfound is for patients in Cohort A in the 2020 update.
====Endocrine therapy====
*Abiraterone (Zytiga) 1000 mg PO once per day on days 1 to 28
====Supportive therapy====
*Prednisone (Sterapred) 5 mg PO twice per day or 10 mg PO once per day on days 1 to 28
28-day cycles
===References===
#PROfound: de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. Epub 2020 Apr 28. link to original article dosing details in manuscript have been reviewed by our editors link to supplementary appendix EuroPMC NCT02987543
## Update: Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Özgüroğlu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. Epub 2020 Sep 20. link to original article EuroPMC
## HRQoL analysis: Thiery-Vuillemin A, de Bono J, Hussain M, Roubaud G, Procopio G, Shore N, Fizazi K, Dos Anjos G, Gravis G, Joung JY, Matsubara N, Castellano D, Degboe A, Gresty C, Kang J, Allen A, Poehlein C, Saad F. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Mar;23(3):393-405. Epub 2022 Feb 11. Erratum in: Lancet Oncol. 2022 Apr;23(4):e161. link to original article EuroPMC
#TRITON3: Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. Epub 2023 Feb 16. link to original article link to PMC article dosing details in supplement have been reviewed by our editors EuroPMC NCT02975934
#MAGNITUDE: Chi KN, Rathkopf D, Smith MR, Efstathiou E, Attard G, Olmos D, Lee JY, Small EJ, Pereira de Santana Gomes AJ, Roubaud G, Saad M, Zurawski B, Sakalo V, Mason GE, Francis P, Wang G, Wu D, Diorio B, Lopez-Gitlitz A, Sandhu S; MAGNITUDE Principal Investigators. Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2023 Jun 20;41(18):3339-3351. Epub 2023 Mar 23. link to original article link to PMC article EuroPMC NCT03748641
##Update: Chi KN, Sandhu S, Smith MR, Attard G, Saad M, Olmos D, Castro E, Roubaud G, Pereira de Santana Gomes AJ, Small EJ, Rathkopf DE, Gurney H, Jung W, Mason GE, Dibaj S, Wu D, Diorio B, Urtishak K, Del Corral A, Francis P, Kim W, Efstathiou E. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. Ann Oncol. 2023 Sep;34(9):772-782. Epub 2023 Jul 1. link to original article link to PMC article EuroPMC
##PRO analysis: Rathkopf DE, Roubaud G, Chi KN, Efstathiou E, Attard G, Olmos D, Small EJ, Saad M, Castro E, Kim W, Wu D, Bertzos K, Dibaj S, Zhang J, Francis P, Smith MR. Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial. Eur Urol. 2024 Sep 23:S0302-2838(24)02594-6. Epub ahead of print. link to original article EuroPMC
==Abiraterone & Niraparib==
===Regimen===
Study 	Dates of enrollment 	Evidence
Saad et al. 2021 (BEDIVERE)	2016-10-24 to 2019-07-16	Phase 1b
Note: This was the RP2D which was used in the MAGNITUDE trial (see below; MAGNITUDE used a combination pill and is considered a different regimen).
====Endocrine therapy====
*Abiraterone (Zytiga) 1000 mg PO once per day
====Targeted therapy====
*Niraparib (Zejula) 200 mg PO once per day
====Supportive therapy====
*Prednisone (Sterapred) 5 mg PO twice per day
Continued indefinitely
===References===
#BEDIVERE: Saad F, Chi KN, Shore ND, Graff JN, Posadas EM, Lattouf JB, Espina BM, Zhu E, Yu A, Hazra A, De Meulder M, Mamidi RNVS, Bradic B, Francis P, Hayreh V, Rezazadeh Kalebasty A. Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE). Cancer Chemother Pharmacol. 2021 Jul;88(1):25-37. Epub 2021 Mar 22. link to original article link to PMC article EuroPMC NCT02924766
==Abiraterone & Niraparib (combined pill)==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Chi et al. 2023 (MAGNITUDE)	2019-05 to 2021-03 	Phase 3 (E-RT-esc)	Abiraterone	Longer rPFS (primary endpoint)Median rPFS: 16.6 vs 10.9 mo(HR 0.53, 95% CI 0.36-0.79)
====Anticancer therapy====
*Niraparib and abiraterone (Akeega) 200/1000 mg PO once per day
====Supportive therapy====
*Prednisone (Sterapred) 5 mg PO twice per day
Continued indefinitely
===References===
#MAGNITUDE: Chi KN, Rathkopf D, Smith MR, Efstathiou E, Attard G, Olmos D, Lee JY, Small EJ, Pereira de Santana Gomes AJ, Roubaud G, Saad M, Zurawski B, Sakalo V, Mason GE, Francis P, Wang G, Wu D, Diorio B, Lopez-Gitlitz A, Sandhu S; MAGNITUDE Principal Investigators. Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2023 Jun 20;41(18):3339-3351. Epub 2023 Mar 23. link to original article link to PMC article EuroPMC NCT03748641
##Update: Chi KN, Sandhu S, Smith MR, Attard G, Saad M, Olmos D, Castro E, Roubaud G, Pereira de Santana Gomes AJ, Small EJ, Rathkopf DE, Gurney H, Jung W, Mason GE, Dibaj S, Wu D, Diorio B, Urtishak K, Del Corral A, Francis P, Kim W, Efstathiou E. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. Ann Oncol. 2023 Sep;34(9):772-782. Epub 2023 Jul 1. link to original article link to PMC article EuroPMC
##PRO analysis: Rathkopf DE, Roubaud G, Chi KN, Efstathiou E, Attard G, Olmos D, Small EJ, Saad M, Castro E, Kim W, Wu D, Bertzos K, Dibaj S, Zhang J, Francis P, Smith MR. Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial. Eur Urol. 2024 Sep 23:S0302-2838(24)02594-6. Epub ahead of print. link to original article EuroPMC
==Docetaxel & Prednisone==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Fizazi et al. 2023 (TRITON3)	2017-02-08 to 2022-02-02	Phase 3 (C)	Rucaparib 	Shorter PFSi (primary endpoint)Median PFSi: 6.4 vs 10.2 mo(HR 1.64, 95% CI 1.25-2.13)
====Chemotherapy====
*Docetaxel (Taxotere) 75 mg/m2 IV once on day 1
====Endocrine therapy====
*Prednisone (Sterapred) 5 mg PO twice per day on days 1 to 21
21-day cycle for up to 10 cycles
===References===
#TRITON3: Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. Epub 2023 Feb 16. link to original article link to PMC article dosing details in supplement have been reviewed by our editors EuroPMC NCT02975934
==Docetaxel & Prednisolone==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Fizazi et al. 2023 (TRITON3)	2017-02-08 to 2022-02-02	Phase 3 (C)	Rucaparib 	Shorter PFSi (primary endpoint)Median PFSi: 6.4 vs 10.2 mo(HR 1.64, 95% CI 1.25-2.13)
====Chemotherapy====
*Docetaxel (Taxotere) 75 mg/m2 IV once on day 1
====Endocrine therapy====
*Prednisolone (Millipred) 5 mg PO twice per day on days 1 to 21
21-day cycle for up to 10 cycles
===References===
#TRITON3: Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. Epub 2023 Feb 16. link to original article link to PMC article dosing details in supplement have been reviewed by our editors EuroPMC NCT02975934
==Enzalutamide monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Fizazi et al. 2023 (TRITON3) 	2017-02-08 to 2022-02-02	Phase 3 (C)	Rucaparib 	Shorter PFSi (primary endpoint)Median PFSi: 6.4 vs 10.2 mo(HR 1.64, 95% CI 1.25-2.13)
de Bono et al. 2020 (PROfound)	2017-04 to 2018-11 	Phase 3 (C)	Olaparib 	Seems to have shorter OS1Median OS: 14.7 vs 19.1 mo(HR 1.45, 95% CI 1.03-2.00)Shorter rPFSMedian rPFS: 3.6 vs 7.4 mo(HR 2.94, 95% CI 2.13-4.00)
Fizazi et al. 2023 (TALAPRO-2)	2018-12-18 to 2022-01-20	Phase 3 (C)	Enzalutamide & Talazoparib	Shorter rPFS (primary endpoint)Median rPFS: 13.8 vs NYR mo(HR 2.22, 95% CI 1.64-3.03)Might have shorter OS (secondary endpoint)Median OS: 33.7 vs NYR mo(HR 1.45, 95% CI 0.97-2.17)
1Reported OS efficacy for PROfound is for patients in Cohort A in the 2020 update.
====Endocrine therapy====
*Enzalutamide (Xtandi) 160 mg PO once per day
Continued indefinitely
===References===
#PROfound: de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. Epub 2020 Apr 28. link to original article dosing details in manuscript have been reviewed by our editors link to supplementary appendix EuroPMC NCT02987543
## Update: Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Özgüroğlu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. Epub 2020 Sep 20. link to original article EuroPMC
## HRQoL analysis: Thiery-Vuillemin A, de Bono J, Hussain M, Roubaud G, Procopio G, Shore N, Fizazi K, Dos Anjos G, Gravis G, Joung JY, Matsubara N, Castellano D, Degboe A, Gresty C, Kang J, Allen A, Poehlein C, Saad F. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Mar;23(3):393-405. Epub 2022 Feb 11. Erratum in: Lancet Oncol. 2022 Apr;23(4):e161. link to original article EuroPMC
#TRITON3: Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. Epub 2023 Feb 16. link to original article link to PMC article dosing details in supplement have been reviewed by our editors EuroPMC NCT02975934
#TALAPRO-2: Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschäbitz S, Oldenburg J, Ye D, Lin X, Healy CG, Di Santo N, Laird AD, Zohren F, Agarwal N. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med. 2024 Jan;30(1):257-264. Epub 2023 Dec 4. Erratum in: Nat Med. 2024 May;30(5):1505. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT03395197
==Enzalutamide & Talazoparib==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Fizazi et al. 2023 (TALAPRO-2)	2018-12-18 to 2022-01-20	Phase 3 (E-esc)	Enzalutamide	Longer rPFS (primary endpoint)Median rPFS: NYR vs 13.8 mo(HR 0.45, 95% CI 0.33-0.61)Might have longer OS (secondary endpoint)Median OS: NYR vs 33.7 mo(HR 0.69, 95% CI 0.46-1.03)
====Endocrine therapy====
*Enzalutamide (Xtandi) 160 mg PO once per day
====Targeted therapy====
*Talazoparib (Talzenna) 0.5 mg PO once per day
Continued indefinitely
===References===
#TALAPRO-2: Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschäbitz S, Oldenburg J, Ye D, Lin X, Healy CG, Di Santo N, Laird AD, Zohren F, Agarwal N. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med. 2024 Jan;30(1):257-264. Epub 2023 Dec 4. Erratum in: Nat Med. 2024 May;30(5):1505. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT03395197
==Olaparib monotherapy==
===Regimen variant #1, 300 mg twice per day===
FDA-recommended dose
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
de Bono et al. 2020 (PROfound)	2017-04 to 2018-11 	Phase 3 (E-RT-switch-ooc)	Physician's choice of:1a. Abiraterone1b. Enzalutamide	Longer rPFS (primary endpoint)Median rPFS: 7.4 vs 3.6 mo(HR 0.34, 95% CI 0.25-0.47)Seems to have longer OS1 (secondary endpoint)Median OS: 19.1 vs 14.7 mo(HR 0.69, 95% CI 0.50-0.97)
1Reported OS efficacy is for patients in Cohort A in the 2020 update.
====Prior treatment criteria====
*Progression on abiraterone or enzalutamide
====Biomarker eligibility criteria====
*Cohort A: 1+ alterations in BRCA1, BRCA2, or ATM
*Cohort B: 1+ alterations in BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L
====Targeted therapy====
*Olaparib (Lynparza) 300 mg PO twice per day
Continued indefinitely
===Regimen variant #2, 400 mg twice per day===
Study 	Dates of enrollment 	Evidence
Kaufman et al. 2014 (Study 42)	2010-02-21 to 2012-07-31	Phase 2, fewer than 20 pts in subgroup
Mateo et al. 2015 (TOPARP-A) 	2012-07 to 2014-09 	Phase 2
====Biomarker eligibility criteria====
*Study 42: Germline BRCA1/2 mutations and had progression on hormonal and one systemic therapy
*TOPARP-A: Patients who were found to have homozygous deletions, deleterious mutations, or both in DNA-repair genes were much more likely to respond to olaparib
====Targeted therapy====
*Olaparib (Lynparza) 400 mg PO twice per day
Continued indefinitely
===References===
#Study 42: Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Steiner M, Loman N, Bowen K, Fielding A, Domchek SM. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015 Jan 20;33(3):244-50. Epub 2014 Nov 3. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01078662
#TOPARP-A: Mateo J, Carreira S, Sandhu S, Miranda S, Mossop H, Perez-Lopez R, Nava Rodrigues D, Robinson D, Omlin A, Tunariu N, Boysen G, Porta N, Flohr P, Gillman A, Figueiredo I, Paulding C, Seed G, Jain S, Ralph C, Protheroe A, Hussain S, Jones R, Elliott T, McGovern U, Bianchini D, Goodall J, Zafeiriou Z, Williamson CT, Ferraldeschi R, Riisnaes R, Ebbs B, Fowler G, Roda D, Yuan W, Wu YM, Cao X, Brough R, Pemberton H, A'Hern R, Swain A, Kunju LP, Eeles R, Attard G, Lord CJ, Ashworth A, Rubin MA, Knudsen KE, Feng FY, Chinnaiyan AM, Hall E, de Bono JS. DNA-Repair Defects and Olaparib in Metastatic Prostate Cancer. N Engl J Med. 2015 Oct 29;373(18):1697-708. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01682772
#PROfound: de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. Epub 2020 Apr 28. link to original article dosing details in manuscript have been reviewed by our editors link to supplementary appendix EuroPMC NCT02987543
## Update: Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Özgüroğlu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. Epub 2020 Sep 20. link to original article EuroPMC
## HRQoL analysis: Thiery-Vuillemin A, de Bono J, Hussain M, Roubaud G, Procopio G, Shore N, Fizazi K, Dos Anjos G, Gravis G, Joung JY, Matsubara N, Castellano D, Degboe A, Gresty C, Kang J, Allen A, Poehlein C, Saad F. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Mar;23(3):393-405. Epub 2022 Feb 11. Erratum in: Lancet Oncol. 2022 Apr;23(4):e161. link to original article EuroPMC
==Rucaparib monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Abida et al. 2020 (TRITON2) 	2017 to not reported 	Phase 2 (RT) 	 	
Fizazi et al. 2023 (TRITON3)	2017-02-08 to 2022-02-02	Phase 3 (E-switch-ooc)	Physician's choice of:1a. Abiraterone1b. Enzalutamide1c. Docetaxel & Prednisone1d. Docetaxel & Prednisolone	Longer PFSi (primary endpoint)Median PFSi: 10.2 vs 6.4 mo(HR 0.61, 95% CI 0.47-0.80)
====Prior treatment criteria====
*TRITON3: Progression after treatment with a second-generation androgen-receptor pathway inhibitor
====Biomarker eligibility criteria====
*TRITON3: 1+ alterations in BRCA1, BRCA2, or ATM
====Targeted therapy====
*Rucaparib (Rubraca) 600 mg PO twice per day on days 1 to 28
28-day cycles
===References===
# TRITON2: Abida W, Patnaik A, Campbell D, Shapiro J, Bryce AH, McDermott R, Sautois B, Vogelzang NJ, Bambury RM, Voog E, Zhang J, Piulats JM, Ryan CJ, Merseburger AS, Daugaard G, Heidenreich A, Fizazi K, Higano CS, Krieger LE, Sternberg CN, Watkins SP, Despain D, Simmons AD, Loehr A, Dowson M, Golsorkhi T, Chowdhury S; TRITON2 investigators. Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration. J Clin Oncol. 2020 Nov 10;38(32):3763-3772. Epub 2020 Aug 14. link to original article dosing details in abstract have been reviewed by our editors link to PMC article EuroPMC NCT02952534
#TRITON3: Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. Epub 2023 Feb 16. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02975934
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