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ACTIVE NOT RECRUITING
NCT03748641
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

765

Start Date

2019-01-25

Completion Date

2027-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Niraparib

Participants will receive niraparib 200 mg capsules or tablets once daily.

DRUG

Abiraterone Acetate

Participants will receive AA 1000 mg tablets once daily.

DRUG

Prednisone

Participants will receive prednisone 10 mg tablets daily.

DRUG

Placebo

Participants will receive matching placebo once daily.

DRUG

New Formulation of Niraparib and Abiraterone Acetate (AA)

Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.

Locations (318)

Urology Centers Of Alabama

Homewood, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

Urological Associates of Southern Arizona, P.C.

Tucson, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

Kaiser Permanente

Riverside, California, United States

San Bernardino Urological Associates

San Bernardino, California, United States

University of California San Francisco

San Francisco, California, United States

Sansum Clinic Pharm

Santa Barbara, California, United States

The Urology Center of Colorado

Denver, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

VA Connecticut Healthcare

West Haven, Connecticut, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Advanced Urology Institute

Daytona Beach, Florida, United States

University of Florida Health Jacksonville

Jacksonville, Florida, United States

Mayo Clinic - Division Of Hematology/oncology

Jacksonville, Florida, United States

Veterans Affairs Medical Ctr

Hines, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

First Urology

Jeffersonville, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Healthcare

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Rcca Md, Llc

Bethesda, Maryland, United States

Chesapeake Urology Research Associates

Towson, Maryland, United States

Massachusetts General

Boston, Massachusetts, United States

Michigan Institute of Urology

Troy, Michigan, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Adult Pediatric Urology & Urogynecology, P.C

Omaha, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Delaware Valley Urology, LLC

Mount Laurel, New Jersey, United States

New York Oncology Hematology

Albany, New York, United States

Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Upstate Cancer Center

Syracuse, New York, United States

Helios Clinical Research, LLC

Middleburg Heights, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Lancaster Urology

Lancaster, Pennsylvania, United States

VA Pittsburgh

Pittsburgh, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Urology Associates

Nashville, Tennessee, United States

Houston Metro Urology

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Salem VA Medical Center

Salem, Virginia, United States

Urology of Virginia, PLCC

Virginia Beach, Virginia, United States

NorthWest Medical Specialties, PLLC

Tacoma, Washington, United States

Hospital Aleman

Buenos Aires, Argentina

Centro Oncológico Korben

Buenos Aires, Argentina

CEMIC Saavedra

Buenos Aires, Argentina

Centro de Urologia (CDU)

Ciudad Automoma Buenos Aires, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Argentina

Hospital Privado de Comunidad

Mar del Plata, Argentina

Centro de Investigacion Pergamino SA

Pergamino, Argentina

Sanatorio Britanico de Rosario

Rosario, Argentina

Sanatorio Parque

Rosario, Argentina

ARS Médica

San Salvador de Jujuy, Argentina

Royal Adelaide Hospital

Adelaide, Australia

Pindara Private Hospital

Benowa, Australia

Sunshine Coast University Hospital

Birtinya, Australia

Princess Alexandra Hospital

Brisbane, Australia

St Vincent s Hospital Sydney

Darlinghurst, Australia

Royal Hobart Hospital

Hobart, Australia

Macquarie University

Macquarie University, Australia

Eye Surgery Associates

Malvern, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Hollywood Private Hospital

Nedlands, Australia

Prince Of Wales Hospital

Randwick, Australia

Sydney Adventist Hospital

Wahroonga, Australia

Wollongong Private Hospital

Wollongong, Australia

OLV Ziekenhuis Aalst

Aalst, Belgium

ZAS Augustinus

Antwerp, Belgium

Grand Hopital de Charleroi, site Notre Dame

Charleroi, Belgium

AZ Maria Middelares

Ghent, Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, Belgium

ZNA Jan Palfijn

Merksem, Belgium

Fundacao Pio XII

Barretos, Brazil

PERSONAL Oncologia de Precisao e Personalizada

Belo Horizonte, Brazil

Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

Brasília, Brazil

CIONC Centro Integrado de Oncologia de Curitiba

Curitiba, Brazil

Pronutrir

Fortaleza, Brazil

Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

Goiânia, Brazil

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

Ijuí, Brazil

Fundacao Sao Francisco Xavier

Ipatinga, Brazil

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, Brazil

Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.

Maceió, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, Brazil

Universidade do Estado do Rio de Janeiro - UERJ

Rio de Janeiro, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, Brazil

Hospital Santa Isabel

Salvador, Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, Brazil

Irmandade Santa Casa de Misericordia de Sao Paulo

São Paulo, Brazil

Instituto de Ensino e Pesquisa São Lucas

São Paulo, Brazil

And 218 more locations on ClinicalTrials.gov