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.

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Castration-Resistant Prostatic Cancer

Prostatic Neoplasms, Castration-Resistant

Prostatic Neoplasms

Genitourinary Cancer

Advanced Solid Tumors

Prostate Neoplasms

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Placebo

Prednisone

Niraparib

Abiraterone Acetate

New Formulation of Niraparib and Abiraterone Acetate (AA)

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

As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred 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.

As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan >=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 <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.

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.

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.

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.

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 Hôpital 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

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.

ZAS Augustinus

Grand Hopital de Charleroi, site Notre Dame

Specialized Hospital for Active Treatment in Oncology EAD

SHATOD 'Dr. Marko Antonov Markov'

British Columbia Cancer Agency Vancouver Island Centre

McMaster Institute of Urology

Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)

Sunnybrook Health Sciences Center

Saskatoon Cancer Centre

Cancer Hospital Chinese Academy of Medical Sciences

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

Drug clinical trial ethics committee of Ningbo First Hospital

Huashan Hospital Fudan University

ShangHai Huadong Hospital

The Fifth People's Hospital of Shanghai, Fudan University

Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Trials at a glance

Trials at a glance

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Outcome measures

Primary outcome measures

Secondary outcome measures