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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000300-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Foundation Medicine | INDUSTRY |
| Myriad Genetics, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.
This is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (HRR) pathway. Subjects will be divided into two cohorts based on HRR gene mutation status.
Approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib | Experimental | Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions |
|
| Enzalutamide OR abiraterone acetate | Active Comparator | Enzalutamide: Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily. Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg or 500 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg administered twice daily orally. Prednisolone is permitted for use instead of prednisone if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olaparib | Drug | 300 mg (2x 150 mg tablets) twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only | The time from randomisation until the date of objective radiological disease progression (determined by RECIST 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG-3) (bone)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Progression is defined using (i) Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue, as a >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters; (ii) Prostate Cancer Working Group 3 (PGWG-3) for bone as >= 2 new bone lesions on the 1st week 8 scan compared to baseline. The confirmatory scan, >=6 weeks later, must show >=2 more new bone lesions (for a total of >=4 new bone lesions since baseline). | Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only | ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR. |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Johann de Bono, M.D., Ph.D. | The Institute of Cancer Research, United Kingdom | Principal Investigator |
| Maha Hussain, M.D., FACP, FASCO | Northwestern University, United States of America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anchorage | Alaska | 99503 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40525978 | Derived | Mayerhoefer ME, Kienzle A, Woo S, Vargas HA. Update on Liquid Biopsy. Radiology. 2025 Jun;315(3):e241030. doi: 10.1148/radiol.241030. | |
| 37963304 | Derived | Mateo J, de Bono JS, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Agarwal N, Olmos D, Thiery-Vuillemin A, Ozguroglu M, Mehra N, Matsubara N, Young Joung J, Padua C, Korbenfeld E, Kang J, Marshall H, Lai Z, Barnicle A, Poehlein C, Lukashchuk N, Hussain M. Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial. J Clin Oncol. 2024 Feb 10;42(5):571-583. doi: 10.1200/JCO.23.00339. Epub 2023 Nov 14. |
| Label | URL |
|---|---|
| CSP redacted | View source |
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Subjects were divided into two cohorts based on HRR gene mutation status. Subjects with mutations in either BRCA1, BRCA2, or ATM are in Cohort A whereas subjects with mutations among 12 other genes involved in the HRR pathway (BARD1, BRIP1, CDK12, CHEK1,CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L) are in Cohort B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A Olaparib 300mg bd | 2x150mg film-coated tablets |
| FG001 | Cohort A Investigators Choice of NHA | either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2019 | Jan 29, 2021 |
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| enzalutamide | Drug | 160 mg (4 x 40 mg capsules) once daily |
|
|
| abiraterone acetate | Drug | 1,000 mg (4 x 250 mg tablets) once daily |
|
|
| abiraterone acetate | Drug | 1,000 mg (2 x 500 mg tablets) once daily |
|
|
| enzalutamide | Drug | 160 mg (4 x 40 mg tablets) once daily |
|
|
| Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
| Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B | The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. | Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
| Time to Pain Progression - Cohort A Only | Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain [Item 3] and Analgesic Quantification Algorithm [AQA] score. | Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
| Overall Survival (OS) - Cohort A Only | Number of Participants with Overall Survival (OS) - Cohort A only. | Approximately 35 months after the first patient was randomised. |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Research Site | Tucson | Arizona | 85741 | United States |
| Research Site | Duarte | California | 91010 | United States |
| Research Site | San Diego | California | 92161 | United States |
| Research Site | Santa Barbara | California | 93105 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30318 | United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Research Site | Jeffersonville | Indiana | 47130 | United States |
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| Research Site | Baltimore | Maryland | 21287 | United States |
| Research Site | Towson | Maryland | 21204 | United States |
| Research Site | Omaha | Nebraska | 68130 | United States |
| Research Site | Las Vegas | Nevada | 89135 | United States |
| Research Site | Albany | New York | 12208 | United States |
| Research Site | Brooklyn | New York | 11201 | United States |
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| Research Site | The Bronx | New York | 10468 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
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| Research Site | Springfield | Oregon | 97477 | United States |
| Research Site | Tualatin | Oregon | 97062 | United States |
| Research Site | Charleston | South Carolina | 29401 | United States |
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| Research Site | Germantown | Tennessee | 38138 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Salt Lake City | Utah | 84112 | United States |
| Research Site | Salt Lake City | Utah | 84148 | United States |
| Research Site | Spokane | Washington | 99202 | United States |
| Research Site | Wheeling | West Virginia | 26003 | United States |
| Research Site | Buenos Aires | 1426 | Argentina |
| Research Site | Buenos Aires | C1118AAT | Argentina |
| Research Site | Buenos Aires | C1120AAT | Argentina |
| Research Site | CABA | C1280AEB | Argentina |
| Research Site | La Rioja | 5300 | Argentina |
| Research Site | Rosario | 2000 | Argentina |
| Research Site | Adelaide | 5000 | Australia |
| Research Site | Box Hill | 3128 | Australia |
| Research Site | Clayton | 3168 | Australia |
| Research Site | Greenslopes | 4120 | Australia |
| Research Site | Herston | 4029 | Australia |
| Research Site | Macquarie University | 2109 | Australia |
| Research Site | Melbourne | 3000 | Australia |
| Research Site | Nedlands | 6009 | Australia |
| Research Site | Randwick | 2031 | Australia |
| Research Site | Waratah | 2298 | Australia |
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| Research Site | Barretos | 14784-400 | Brazil |
| Research Site | Belo Horizonte | 30110-022 | Brazil |
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| Research Site | Recife | 50040-000 | Brazil |
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| Research Site | São Paulo | 01321-001 | Brazil |
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| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Kelowna | British Columbia | V1Y 5L3 | Canada |
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| Research Site | Oakville | Ontario | L6H 3P1 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Research Site | Montreal | Quebec | H2X 3E4 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Québec | Quebec | G1J 1Z4 | Canada |
| Research Site | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Research Site | Odense C | 5000 | Denmark |
| Research Site | Besançon | 25030 | France |
| Research Site | Bordeaux | 33000 | France |
| Research Site | Caen | 14000 | France |
| Research Site | Lille | 59020 | France |
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| Research Site | Paris | 75014 | France |
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| Research Site | Toulouse | 31100 | France |
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| Research Site | Villejuif | 94805 | France |
| Research Site | Bergisch Gladbach | 51465 | Germany |
| Research Site | Berlin | 13055 | Germany |
| Research Site | Bremen | 28277 | Germany |
| Research Site | Cologne | 50968 | Germany |
| Research Site | Duisburg | 47179 | Germany |
| Research Site | Düsseldorf | 40225 | Germany |
| Research Site | Hamburg | 22399 | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Holzminden | 37603 | Germany |
| Research Site | Jena | 07747 | Germany |
| Research Site | Magdeburg | 39120 | Germany |
| Research Site | Nuremberg | 90491 | Germany |
| Research Site | Nürtingen | 72622 | Germany |
| Research Site | Tübingen | 72076 | Germany |
| Research Site | Wuppertal | 42109 | Germany |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Kfar Saba | 95847 | Israel |
| Research Site | Petah Tikva | 4941492 | Israel |
| Research Site | Ramat Gan | 5265601 | Israel |
| Research Site | Ẕerifin | 70300 | Israel |
| Research Site | Ancona | 60126 | Italy |
| Research Site | Arezzo | 52100 | Italy |
| Research Site | Bari | 70124 | Italy |
| Research Site | Brescia | 25100 | Italy |
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| Research Site | Milan | 20133 | Italy |
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| Research Site | Modena | 41124 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Trento | 38100 | Italy |
| Research Site | Bunkyō City | 113-8431 | Japan |
| Research Site | Bunkyō City | 113-8510 | Japan |
| Research Site | Bunkyō City | 113-8603 | Japan |
| Research Site | Fukuoka | 812-8582 | Japan |
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| Research Site | Amsterdam | 1066 CX | Netherlands |
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| Research Site | Nijmegen | 6525 GA | Netherlands |
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| Research Site | Zwolle | 8025 AB | Netherlands |
| Research Site | Lørenskog | N-1478 | Norway |
| Research Site | Busan | 49241 | South Korea |
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| Research Site | Seoul | 03722 | South Korea |
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| Research Site | Girona | 17007 | Spain |
| Research Site | Madrid | 08035 | Spain |
| Research Site | Madrid | 28040 | Spain |
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| Research Site | Málaga | 29010 | Spain |
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| Research Site | Seville | 41009 | Spain |
| Research Site | Gothenburg | 413 45 | Sweden |
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| Research Site | Adana | 01120 | Turkey (Türkiye) |
| Research Site | Ankara | 06230 | Turkey (Türkiye) |
| Research Site | Ankara | 06340 | Turkey (Türkiye) |
| Research Site | Ankara | 06590 | Turkey (Türkiye) |
| Research Site | Cordaleo | 35575 | Turkey (Türkiye) |
| Research Site | Edirne | 22030 | Turkey (Türkiye) |
| Research Site | Istanbul | 34030 | Turkey (Türkiye) |
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| Research Site | London | EC1M 6BQ | United Kingdom |
| Research Site | London | NW1 2PG | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Romford | RM7 0BE | United Kingdom |
| Research Site | Sutton | SM25PT | United Kingdom |
| 35598359 | Derived | Roubaud G, Ozguroglu M, Penel N, Matsubara N, Mehra N, Kolinsky MP, Procopio G, Feyerabend S, Joung JY, Gravis G, Nishimura K, Gedye C, Padua C, Shore N, Thiery-Vuillemin A, Saad F, van Alphen R, Carducci MA, Desai C, Brickel N, Poehlein C, Del Rosario P, Fizazi K. Olaparib tolerability and common adverse-event management in patients with metastatic castration-resistant prostate cancer: Further analyses from the PROfound study. Eur J Cancer. 2022 Jul;170:73-84. doi: 10.1016/j.ejca.2022.04.016. Epub 2022 May 19. |
| 35229141 | Derived | Matsubara N, Nishimura K, Kawakami S, Joung JY, Uemura H, Goto T, Kwon TG, Sugimoto M, Kato M, Wang SS, Pang ST, Chen CH, Fujita T, Nii M, Shen L, Dujka M, Hussain M, de Bono J. Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis. Jpn J Clin Oncol. 2022 May 5;52(5):441-448. doi: 10.1093/jjco/hyac015. |
| 35157830 | Derived | 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. doi: 10.1016/S1470-2045(22)00017-1. Epub 2022 Feb 11. |
| 35091440 | Derived | Hussain M, Corcoran C, Sibilla C, Fizazi K, Saad F, Shore N, Sandhu S, Mateo J, Olmos D, Mehra N, Kolinsky MP, Roubaud G, Ozguroglu M, Matsubara N, Gedye C, Choi YD, Padua C, Kohlmann A, Huisden R, Elvin JA, Kang J, Adelman CA, Allen A, Poehlein C, de Bono J. Tumor Genomic Testing for >4,000 Men with Metastatic Castration-resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib). Clin Cancer Res. 2022 Apr 14;28(8):1518-1530. doi: 10.1158/1078-0432.CCR-21-3940. |
| 32955174 | Derived | 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, Ozguroglu 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. doi: 10.1056/NEJMoa2022485. Epub 2020 Sep 20. |
| 32343890 | Derived | 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. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28. |
| redacted SAP | View source |
| Redacted CSR synopsis | View source |
| FG002 | Cohort B Olaparib 300mg bd | 2x150mg film-coated tablets |
| FG003 | Cohort B Investigators Choice of NHA | either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A Olaparib 300mg bd | 2x150mg film-coated tablets |
| BG001 | Cohort A Investigators Choice of NHA | either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) |
| BG002 | Cohort B Olaparib 300mg bd | 2x150mg film-coated tablets |
| BG003 | Cohort B Investigators Choice of NHA | either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Secondary | Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only | ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR. | Evaluable for response | Posted | Count of Participants | Participants | Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
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| Secondary | Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B | The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. | Full Analysis Set | Posted | Median | 95% Confidence Interval | Months | Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
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| Secondary | Time to Pain Progression - Cohort A Only | Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain [Item 3] and Analgesic Quantification Algorithm [AQA] score. | Full Analysis Set | Posted | Median | 95% Confidence Interval | Months | Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
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| Secondary | Overall Survival (OS) - Cohort A Only | Number of Participants with Overall Survival (OS) - Cohort A only. | Full analysis set | Posted | Count of Participants | Participants | Approximately 35 months after the first patient was randomised. |
|
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| Primary | Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only | The time from randomisation until the date of objective radiological disease progression (determined by RECIST 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG-3) (bone)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Progression is defined using (i) Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue, as a >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters; (ii) Prostate Cancer Working Group 3 (PGWG-3) for bone as >= 2 new bone lesions on the 1st week 8 scan compared to baseline. The confirmatory scan, >=6 weeks later, must show >=2 more new bone lesions (for a total of >=4 new bone lesions since baseline). | Full Analysis Set | Posted | Median | 95% Confidence Interval | Months | Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). |
|
From the time of signature of informed consent throughout the treatment period (median duration of treatment of 7.5 and 3.9 months for Olaparib and Investigators Choice of NHA respectively) up to and including the 30-day follow-up period
There were 131 subjects randomised to the Investigators Choice of NHA treatment group (Full Analysis Set), however 1 of these subjects did not receive treatment (resulting in 130 in the Safety Analysis Set). Hence, for the Investigators Choice of NHA, the Total number at risk for all-cause mortality = 131 while the Total # at Risk by any Serious Adverse Event = 130 and the Total # at Risk by any Other Adverse Event = 130.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A+B Olaparib 300mg bd | 2x150mg film-coated tablets | 160 | 256 | 94 | 256 | 241 | 256 |
| EG001 | Cohort A+B Investigators Choice of NHA | either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone) | 88 | 131 | 39 | 130 | 112 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary ostial stenosis | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stress ulcer | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Budd-Chiari syndrome | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cellulitis of male external genital organ | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Ballismus | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumoni | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_005.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 4, 2019 | Mar 9, 2023 | SAP_015.pdf |
Not provided
| ID | Term |
|---|---|
| C531550 | olaparib |
| C540278 | enzalutamide |
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Missing |
|
|
|
|
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|
|
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
|
|
|