Back to resultsA Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (MAGNITUDE)
Primary Purpose
Castration-Resistant Prostatic Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Niraparib
Abiraterone Acetate
Prednisone
Placebo
New Formulation of Niraparib and Abiraterone Acetate (AA)
Sponsored by
About this trial
This is an interventional treatment trial for Castration-Resistant Prostatic Cancer
Eligibility Criteria
Inclusion Criteria:
HRR gene alteration (as identified by the sponsor's required assays) as follows:
- Cohort 1: positive for HRR gene alteration
- Cohort 2: not positive for DRD (that is, HRR gene alteration)
- Cohort 3: eligible by HRR status
- Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
- Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
- Able to continue GnRHa during the study if not surgically castrate
- Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)
Exclusion Criteria:
- Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
- Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
- Symptomatic brain metastases
- History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
- Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy
Sites / Locations
- Urology Centers Of Alabama
- Mayo Clinic Arizona
- Urological Associates of Southern Arizona, P.C.
- Arkansas Urology
- Kaiser Permanente
- San Bernardino Urological Associates
- University of California San Francisco
- Sansum Clinic Pharm
- The Urology Center of Colorado
- Colorado Clinical Research
- VA Connecticut Healthcare
- Bay Pines VA Healthcare System
- Advanced Urology Institute
- University of Florida Health Jacksonville
- Mayo Clinic - Division Of Hematology/oncology
- Veterans Affairs Medical Ctr
- Fort Wayne Medical Oncology and Hematology
- First Urology
- University of Kansas Medical Center
- Norton Healthcare
- Ochsner Clinic Foundation
- Rcca Md, Llc
- Chesapeake Urology Research Associates
- Massachusetts General
- Michigan Institute of Urology
- Kansas City Veterans Affairs Medical Center
- Adult Pediatric Urology & Urogynecology, P.C
- Nebraska Cancer Specialists
- Comprehensive Cancer Centers of Nevada
- Delaware Valley Urology, LLC
- New York Oncology Hematology
- Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
- Memorial Sloan Kettering Cancer Center
- Upstate Cancer Center
- Helios Clinical Research, LLC
- Oregon Urology Institute
- MidLantic Urology
- Lancaster Urology
- VA Pittsburgh
- Carolina Urologic Research Center
- Urology Associates
- Houston Metro Urology
- University of Texas MD Anderson Cancer Center
- Utah Cancer Specialists
- Salem VA Medical Center
- Urology of Virginia, PLCC
- NorthWest Medical Specialties, PLLC
- Hospital Aleman
- Centro Oncológico Korben
- Centro de Urologia (CDU)
- CEMIC Saavedra
- Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
- Hospital Privado - Centro Medico de Cordoba
- Instituto de Investigaciones Clinicas Mar del Plata
- Hospital Privado de Comunidad
- Centro de Investigacion Pergamino SA
- Sanatorio Britanico de Rosario
- Sanatorio Parque
- ARS Médica
- Royal Adelaide Hospital
- Pindara Private Hospital
- Sunshine Coast University Hospital
- Princess Alexandra Hospital
- St. Vincent's Hospital Sydney
- Royal Hobart Hospital
- Macquarie University
- Eye Surgery Associates
- Peter MacCallum Cancer Centre
- Fiona Stanley Hospital
- Hollywood Private Hospital
- Prince Of Wales Hospital
- Sydney Adventist Hospital
- Wollongong Private Hospital
- OLV Ziekenhuis Aalst
- ZNA Middelheim
- Grand Hopital de Charleroi, site Notre Dame
- AZ Maria Middelares
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
- ZNA Jan Palfijn
- Fundacao Pio XII
- PERSONAL - Oncologia de Precisão e Personalizada
- Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
- CIONC - Centro Integrado de Oncologia de Curitiba
- Pronutrir
- Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
- Fundação São Francisco Xavier
- Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
- Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
- Liga Norte Riograndense Contra O Cancer
- Irmandade Santa Casa de Misericordia de Porto Alegre
- Hospital Ernesto Dornelles
- Ministerio da Saude - Instituto Nacional do Cancer
- Universidade do Estado do Rio de Janeiro - UERJ
- Oncoclínicas Rio de Janeiro S.A.
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
- Hospital Santa Isabel
- Fundacao do ABC - Centro Universitario FMABC
- Irmandade Santa Casa de Misericordia de Sao Paulo
- Instituto de Ensino e Pesquisa São Lucas
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
- Hospital Alemao Oswaldo Cruz
- Fundacao Antonio Prudente - A.C. Camargo Cancer Center
- Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
- IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
- Núcleo de Pesquisa São Camilo
- Instituto D'Or de Pesquisa e Ensino (IDOR)
- Instituto do Cancer De Tres Lagoas
- MHAT Deva Maria
- UMHAT 'Dr. Georgi Stranski', EAD
- Complex Oncology Center - Plovdiv EOOD
- Specialized Hospital for Active Treatment in Oncology EAD
- SHATOD 'Dr. Marko Antonov Markov'
- Comprehensive Cancer Center
- Southern Alberta Institute of Urology / Prostate Cancer Centre
- British Columbia Cancer Agency (BCCA) - Vancouver Centre
- British Columbia Cancer Agency - Vancouver Island Centre
- McMaster Institute of Urology
- Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
- Sunnybrook Health Sciences Center
- University Health Network (UHN) Princess Margaret Cancer Centre
- Centre de Recherche du CHUM
- Saskatoon Cancer Centre
- Cancer Hospital Chinese Academy of Medical Sciences
- Peking University First Hospital
- Beijing Friendship Hospital
- Beijing Cancer Hospital of Peking University
- Peking University Third Hospital
- Beijing Hospital
- Sichuan Provincial People's Hospital
- Southwest Hospital, The Third Military Medical University
- Chongqing University Cancer Hospital
- Fujian Medical University Union Hospital
- Sun Yat-Sen Memorial Hospital Sun Yat-sen University
- Guangzhou First Municipal People's Hospital
- Nanjing Drum Tower Hospital
- Jiangsu Cancer Hospital
- Drug clinical trial ethics committee of Ningbo First Hospital
- Renji Hospital, Shanghai Jiaotong University School of Medicine
- Fudan University Shanghai Cancer Center
- Huashan Hospital Fudan University
- ShangHai Huadong Hospital
- The Fifth People's Hospital of Shanghai, Fudan University
- The First Affiliated Hospital of Soochow University
- Tianjin Medical University Cancer Hospital
- The Central Hospital of Wuhan
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
- Wuxi People's Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- Fakultni nemocnice Hradec Kralove
- Krajská nemocnice Liberec
- Uromedical Center s.r.o.
- Multiscan s.r.o.
- Fakultni nemocnice Plzen, Urologicka klinika
- Urologicka klinika 1.LF UK a VFN
- Thomayerova nemocnice, Onkologicka klinika
- Uherskohradistska nemocnice a.s.
- CHRU De Besancon
- Institut Bergonié
- Centre Jean Perrin
- Centre Leon Bérard
- Institut Regional du Cancer de Montpellier Val d'Aurelle
- Polyclinique de Gentilly
- Centre Antoine Lacassagne
- Hopital Europeen Georges-Pompidou
- Institut de Cancérologie de l'Ouest (ICO)
- HIA Begin
- Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
- Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
- Urologicum Duisburg
- Universitätsklinikum des Saarlandes
- Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
- Universitaetsklinikum Muenster
- Studienpraxis Urologie Drs. Feyerabend
- Semmelweis Egyetem, Urológia Klinika
- Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
- Debreceni Egyetem Klinikai Kozpont
- Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
- Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
- Uro-Clin Kft.
- Szegedi Tudomanyegyetem
- Szegedi Tudomanyegyetem
- Markusovszky Egyetemi Oktatokorhaz
- Asaf Harofe Medical Center
- Rambam Health Care Campus
- Rabin Medical Center
- Sheba Medical Center Tel Hashomer
- AUSL Romagna - Ospedale di Faenza
- Ospedale San Raffaele
- ASST Grande Ospedale Metropolitano Niguarda
- Oncologia Medica A - Ist Naz Tumori G Pascale
- Istituto Oncologico Veneto Iov Irccs Padova
- Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
- Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
- Azienda Ospedaliero Universitaria Pisana
- Fondazione Policlinico Universitario A. Gemelli IRCCS
- Campus Bio-Medico di Roma
- Azienda Ospedaliera S. Maria Terni
- A.O.U. Città della Salute e della Scienza
- Ospedale Santa Chiara Trento
- Pusan National University Hospital
- Kyungpook National University Chilgok Hospital
- Keimyung University Dongsan Hospital
- Chungnam National University Hospital
- Chonnam National University Hospital
- National Cancer Center
- Seoul National University Bundang Hospital
- Ajou University Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Gangnam Severance Hospital, Yonsei University Health System
- Samsung Medical Center
- The Catholic University of Korea Seoul St. Mary's Hospital
- Hospital Pulau Pinang
- Hospital Sultan Ismail
- Hospital Likas
- Hospital Kuala Lumpur
- University Malaya Medical Centre
- Sarawak General Hospital
- iBiomed Research Unit
- Mexico Centre for Clinical Research, S.A. de C.V.
- Consultorio de Especialidad en Urologia Privado
- Avix Investigacion Clinica, S.C.
- Consultorio Privado
- NKI-AVL, Amsterdam
- Universitair Medisch Centrum Groningen
- MC Haaglanden Lok Antoniushove - Afd.Interne - INT
- St. Antonius Ziekenhuis (St. Antonius Hospital)
- Canisius-Wilhelminaziekenhuis
- Erasmus MC
- Zuyderland Medical Center
- Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
- Centrum Onkologii im. Prof. F. Lukaszczyka
- Uniwersyteckie Centrum Kliniczne
- Szpitale Pomorskie Sp. z o.o.
- Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
- Urologica Praktyka Lekarska Adam Marcheluk
- Pomorski Uniwersytet Medyczny w Szczecinie
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
- Dolnoslaskie Centrum Onkologii
- Hospitais da universidade de Coimbra
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
- Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria
- Champalimaud Foundation Champalimaud Centre
- H. Santo António - Centro Hospitalar do Porto
- VA Caribbean Healthcare System
- Altai Regional Oncology Dispensary
- Ivanovo Regional Oncology Dispensary
- GUZ Kursk Regional Oncology Dispensary
- Russian Scientific Center of Roentgenoradiology
- Moscow City Clinical Hospital # 62
- Clinical Diagnostic Centre of Nizhny Novgorod Region
- Clinical Oncology Dispensary
- LLC Novaya Clinica
- Pyatigorsk Interdistrict Oncology Dispensary
- Private Medical Institution Euromedservice
- Leningrad Regional Oncology Dispensary
- Russian Scientific Center of Radiology and Surgical Technologies
- Republican Oncology Dispensary
- Oncologic Dispensary No.2
- Tambov Regional Oncology Clinical Dispansary
- Tomsk Cancer Research Institute
- Medical-sanitary unit 'Neftyanik'
- Vologda Regional Oncological Dispensary
- Clinresco Centres Pty Ltd
- Clinical Research Unit
- Hosp. Del Mar
- Hosp. de La Santa Creu I Sant Pau
- Hosp. Clinic I Provincial de Barcelona
- Hospital Juan Canalejo
- Hosp. de Jerez de La Frontera
- Hosp. Univ. Ramon Y Cajal
- Hosp. Clinico San Carlos
- Hosp. Virgen de La Victoria
- Hosp. Quiron Madrid Pozuelo
- Corporacio Sanitari Parc Tauli
- Hosp. Univ. Marques de Valdecilla
- Hosp. Univ. I Politecni La Fe
- Södersjukhuset
- Karolinska Universitetssjukhuset Solna
- Akademiska Sjukhuset
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- Tungs' Taichung MetroHarbor Hospital
- Chi Mei Medical Center - Yong Kang
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital
- Cukurova University, Faculty of Medicine
- Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
- Ankara Bilkent Sehir Hastanesi
- Akdeniz University Medical Faculty
- Trakya University Medical Faculty
- Istanbul University Cerrahpasa Medical Faculty
- Bakirkoy Training and Research Hospital
- Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
- IEU Medical Point Hospital
- Kocaeli University Medical Faculty
- Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
- Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
- Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
- Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
- Ivano-Frankivsk Regional Clinical Hospital
- Municipal non-profit enterprise 'Regional Center of Oncology'
- Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
- State Institution National Cancer Institute
- State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
- Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
- ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
- Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
- Royal Blackburn Hospital
- Royal Lancaster Infirmary
- UCL Cancer Institute
- Torbay Hospital-Devon
- Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1: Participants with mCRPC and HRR Gene Alteration
Cohort 2: Participants with mCRPC and No HRR Gene Alteration
Cohort 3 (Open-label): Participants with mCRPC
Arm Description
Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.
Outcomes
Primary Outcome Measures
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.
Secondary Outcome Measures
Cohort 1: Overall Survival (OS)
Cohort 1: Time to Symptomatic Progression
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
Observed Plasma Concentrations of Niraparib
Observed Plasma Concentrations of Abiraterone
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of Participants With Treatment-Emergent Adverse Events by Severity
Number of Participants With Abnormalities in Laboratory Values
Full Information
NCT ID
NCT03748641
First Posted
November 19, 2018
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03748641
Brief Title
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Acronym
MAGNITUDE
Official Title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
February 19, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
Detailed Description
This study will assess efficacy and safety of niraparib in combination with AAP for the treatment of participants with metastatic castration resistant prostate cancer. Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone and selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), which is found in the testes and adrenals, as well as in prostate tissues and tumors. In participants with metastatic prostate cancer, DNA-repair anomalies are identified in approximately 15 percent (%) to 20% of tumors. The study will consist of 5 phases: a prescreening phase for biomarker evaluation only, a screening phase, a treatment phase, a follow up phase, and an extension phase (either open-label extension [OLE] or long-term extension [LTE]). During the prescreening phase participants will be evaluated for homologous recombination repair (HRR) gene alteration status and then will be assigned to one of the 2 cohorts based on their biomarker status. Treatment will be administered daily and is planned to be continuous until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy, pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 66 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-Resistant Prostatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
765 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Participants with mCRPC and HRR Gene Alteration
Arm Type
Experimental
Arm Description
Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Arm Title
Cohort 2: Participants with mCRPC and No HRR Gene Alteration
Arm Type
Experimental
Arm Description
Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Arm Title
Cohort 3 (Open-label): Participants with mCRPC
Arm Type
Experimental
Arm Description
Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.
Intervention Type
Drug
Intervention Name(s)
Niraparib
Other Intervention Name(s)
JNJ-64091742
Intervention Description
Participants will receive niraparib 200 mg capsules once daily.
Intervention Type
Drug
Intervention Name(s)
Abiraterone Acetate
Intervention Description
Participants will receive AA 1000 mg tablets once daily.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Participants will receive prednisone 10 mg tablets daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo once daily.
Intervention Type
Drug
Intervention Name(s)
New Formulation of Niraparib and Abiraterone Acetate (AA)
Intervention Description
Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
Primary Outcome Measure Information:
Title
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
Description
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.
Time Frame
Up to 32 months
Secondary Outcome Measure Information:
Title
Cohort 1: Overall Survival (OS)
Time Frame
Up to 97 months
Title
Cohort 1: Time to Symptomatic Progression
Time Frame
Up to 97 months
Title
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
Time Frame
Up to 97 months
Title
Observed Plasma Concentrations of Niraparib
Time Frame
Up to 97 months
Title
Observed Plasma Concentrations of Abiraterone
Time Frame
Up to 97 months
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to 96 months
Title
Number of Participants With Treatment-Emergent Adverse Events by Severity
Time Frame
Up to 96 months
Title
Number of Participants With Abnormalities in Laboratory Values
Time Frame
Up to 96 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HRR gene alteration (as identified by the sponsor's required assays) as follows:
Cohort 1: positive for HRR gene alteration
Cohort 2: not positive for DRD (that is, HRR gene alteration)
Cohort 3: eligible by HRR status
Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
Able to continue GnRHa during the study if not surgically castrate
Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)
Exclusion Criteria:
Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
Symptomatic brain metastases
History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers Of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Urological Associates of Southern Arizona, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Kaiser Permanente
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
San Bernardino Urological Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Sansum Clinic Pharm
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Colorado Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
VA Connecticut Healthcare
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Advanced Urology Institute
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
University of Florida Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic - Division Of Hematology/oncology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Veterans Affairs Medical Ctr
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
First Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Rcca Md, Llc
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Massachusetts General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Kansas City Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Adult Pediatric Urology & Urogynecology, P.C
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Delaware Valley Urology, LLC
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
New York Oncology Hematology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Upstate Cancer Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Helios Clinical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Oregon Urology Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Lancaster Urology
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
VA Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
80113
Country
United States
Facility Name
Urology of Virginia, PLCC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
NorthWest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Aleman
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Centro Oncológico Korben
City
Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Facility Name
Centro de Urologia (CDU)
City
Ciudad Automoma Buenos Aires
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
CEMIC Saavedra
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1431FWN
Country
Argentina
Facility Name
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital Privado - Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Mar del Plata
City
Mar Del Plata, Buenos Aires
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Hospital Privado de Comunidad
City
Mar Del Plata
ZIP/Postal Code
B7602CBM
Country
Argentina
Facility Name
Centro de Investigacion Pergamino SA
City
Pergamino
ZIP/Postal Code
B2700CPM
Country
Argentina
Facility Name
Sanatorio Britanico de Rosario
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanatorio Parque
City
Rosario
ZIP/Postal Code
S2000SDV
Country
Argentina
Facility Name
ARS Médica
City
San Salvador De Jujuy
ZIP/Postal Code
Y4600AFW
Country
Argentina
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pindara Private Hospital
City
Benowa
ZIP/Postal Code
4217
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
ZIP/Postal Code
4575
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Facility Name
Macquarie University
City
Macquarie University
ZIP/Postal Code
2109
Country
Australia
Facility Name
Eye Surgery Associates
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Hollywood Private Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Prince Of Wales Hospital
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
ZIP/Postal Code
2076
Country
Australia
Facility Name
Wollongong Private Hospital
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Facility Name
OLV Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Grand Hopital de Charleroi, site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
ZNA Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
PERSONAL - Oncologia de Precisão e Personalizada
City
Belo Horizonte
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
City
Brasilia
ZIP/Postal Code
7020-730
Country
Brazil
Facility Name
CIONC - Centro Integrado de Oncologia de Curitiba
City
Curitiba
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Pronutrir
City
Fortaleza
ZIP/Postal Code
60 810180
Country
Brazil
Facility Name
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Fundação São Francisco Xavier
City
Ipatinga
ZIP/Postal Code
35162 189
Country
Brazil
Facility Name
Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
City
Joinville
ZIP/Postal Code
89201-260
Country
Brazil
Facility Name
Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
City
Maceio
ZIP/Postal Code
57052-765
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59062-000
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
ZIP/Postal Code
90160-093
Country
Brazil
Facility Name
Ministerio da Saude - Instituto Nacional do Cancer
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Universidade do Estado do Rio de Janeiro - UERJ
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Oncoclínicas Rio de Janeiro S.A.
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
Hospital Santa Isabel
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Fundacao do ABC - Centro Universitario FMABC
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa São Lucas
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01421-000
Country
Brazil
Facility Name
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
City
Sao Paulo
ZIP/Postal Code
01509900
Country
Brazil
Facility Name
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
City
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
City
Sorocaba
ZIP/Postal Code
18030-005
Country
Brazil
Facility Name
Núcleo de Pesquisa São Camilo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
São Paulo
ZIP/Postal Code
04502-001
Country
Brazil
Facility Name
Instituto do Cancer De Tres Lagoas
City
Três Lagoas
ZIP/Postal Code
79601-001
Country
Brazil
Facility Name
MHAT Deva Maria
City
Burgas
ZIP/Postal Code
8001
Country
Bulgaria
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Complex Oncology Center - Plovdiv EOOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment in Oncology EAD
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
SHATOD 'Dr. Marko Antonov Markov'
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Comprehensive Cancer Center
City
Vratsa
ZIP/Postal Code
3001
Country
Bulgaria
Facility Name
Southern Alberta Institute of Urology / Prostate Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
British Columbia Cancer Agency (BCCA) - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Island Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
McMaster Institute of Urology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network (UHN) Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre de Recherche du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Cancer Hospital of Peking University
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
ZIP/Postal Code
610072
Country
China
Facility Name
Southwest Hospital, The Third Military Medical University
City
Chongqing
ZIP/Postal Code
400025
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Guangzhou First Municipal People's Hospital
City
GuangZhou
ZIP/Postal Code
510180
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Drug clinical trial ethics committee of Ningbo First Hospital
City
Ningbo
ZIP/Postal Code
315010
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
ShangHai
ZIP/Postal Code
200001
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
ShangHai Huadong Hospital
City
ShangHai
ZIP/Postal Code
200040
Country
China
Facility Name
The Fifth People's Hospital of Shanghai, Fudan University
City
ShangHai
ZIP/Postal Code
200240
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Tianjin Medical University Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The Central Hospital of Wuhan
City
Wuhan
ZIP/Postal Code
430014
Country
China
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Krajská nemocnice Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Uromedical Center s.r.o.
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Multiscan s.r.o.
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Fakultni nemocnice Plzen, Urologicka klinika
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Urologicka klinika 1.LF UK a VFN
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Thomayerova nemocnice, Onkologicka klinika
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Uherskohradistska nemocnice a.s.
City
Uherske Hradiste
ZIP/Postal Code
68668
Country
Czechia
Facility Name
CHRU De Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Leon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Regional du Cancer de Montpellier Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Polyclinique de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Europeen Georges-Pompidou
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Institut de Cancérologie de l'Ouest (ICO)
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
HIA Begin
City
Saint Mande
ZIP/Postal Code
94163
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66424
Country
Germany
Facility Name
Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Studienpraxis Urologie Drs. Feyerabend
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Semmelweis Egyetem, Urológia Klinika
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Uro-Clin Kft.
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Asaf Harofe Medical Center
City
Beer Yaakov
ZIP/Postal Code
60930
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
AUSL Romagna - Ospedale di Faenza
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Oncologia Medica A - Ist Naz Tumori G Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto Iov Irccs Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
128
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria Terni
City
Terni
ZIP/Postal Code
5100
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Santa Chiara Trento
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
ZIP/Postal Code
81100
Country
Malaysia
Facility Name
Hospital Likas
City
Kota Kinabalu
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
iBiomed Research Unit
City
Aguascalientes
ZIP/Postal Code
20010
Country
Mexico
Facility Name
Mexico Centre for Clinical Research, S.A. de C.V.
City
Ciudad de Mexico
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Consultorio de Especialidad en Urologia Privado
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Avix Investigacion Clinica, S.C.
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Consultorio Privado
City
Zapopan
ZIP/Postal Code
45040
Country
Mexico
Facility Name
NKI-AVL, Amsterdam
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
MC Haaglanden Lok Antoniushove - Afd.Interne - INT
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis (St. Antonius Hospital)
City
Nieuwegein
ZIP/Postal Code
3430EM
Country
Netherlands
Facility Name
Canisius-Wilhelminaziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Zuyderland Medical Center
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Centrum Onkologii im. Prof. F. Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Urologica Praktyka Lekarska Adam Marcheluk
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Pomorski Uniwersytet Medyczny w Szczecinie
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii
City
Wrocław
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Hospitais da universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Champalimaud Foundation Champalimaud Centre
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
H. Santo António - Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
VA Caribbean Healthcare System
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Altai Regional Oncology Dispensary
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
GUZ Kursk Regional Oncology Dispensary
City
Kursk
ZIP/Postal Code
305524
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital # 62
City
Moscow
ZIP/Postal Code
125130
Country
Russian Federation
Facility Name
Clinical Diagnostic Centre of Nizhny Novgorod Region
City
Nizhny Novgorod
ZIP/Postal Code
603000
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
LLC Novaya Clinica
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Pyatigorsk Interdistrict Oncology Dispensary
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Private Medical Institution Euromedservice
City
Saint Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies
City
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Republican Oncology Dispensary
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Oncologic Dispensary No.2
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Tambov Regional Oncology Clinical Dispansary
City
Tambov
ZIP/Postal Code
392013
Country
Russian Federation
Facility Name
Tomsk Cancer Research Institute
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Medical-sanitary unit 'Neftyanik'
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Vologda Regional Oncological Dispensary
City
Vologda
ZIP/Postal Code
160012
Country
Russian Federation
Facility Name
Clinresco Centres Pty Ltd
City
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Clinical Research Unit
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Juan Canalejo
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hosp. de Jerez de La Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
403
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Tungs' Taichung MetroHarbor Hospital
City
Taichung
ZIP/Postal Code
435
Country
Taiwan
Facility Name
Chi Mei Medical Center - Yong Kang
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Cukurova University, Faculty of Medicine
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
6560
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Bakirkoy Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
IEU Medical Point Hospital
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
City
Dnipo
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Municipal non-profit enterprise 'Regional Center of Oncology'
City
Khakhiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
State Institution National Cancer Institute
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
City
Poltava
ZIP/Postal Code
36024
Country
Ukraine
Facility Name
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Royal Blackburn Hospital
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
London
ZIP/Postal Code
WC1E 6DD
Country
United Kingdom
Facility Name
Torbay Hospital-Devon
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
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