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

• ClinicalTrials.gov Identifier: NCT03748641
• Recruitment Status: Active, not recruiting
• First Posted: November 21, 2018
• Last Update Posted: August 3, 2022
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

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.

Condition or disease	Intervention/treatment	Phase
Castration-Resistant Prostatic Cancer	Drug: Niraparib; Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Placebo; Drug: New Formulation of Niraparib and Abiraterone Acetate (AA)	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 765 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 25, 2019
• Actual Primary Completion Date: October 8, 2021
• Estimated Study Completion Date: February 19, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1: Participants with mCRPC and HRR Gene Alteration; 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.	Drug: Niraparib; Participants will receive niraparib 200 mg capsules once daily.; Other Name: JNJ-64091742; 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.
Experimental: Cohort 2: Participants with mCRPC and No HRR Gene Alteration; 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.	Drug: Niraparib; Participants will receive niraparib 200 mg capsules once daily.; Other Name: JNJ-64091742; 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.
Experimental: Cohort 3 (Open-label): Participants with mCRPC; Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.	Drug: Prednisone; Participants will receive prednisone 10 mg tablets 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.

Outcome Measures

Primary Outcome Measures :

1. Cohort 1 and 3: Radiographic Progression Free Survival (rPFS) [ Time Frame: Up to 28 months ]
   As per blinded independent central review, rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) as follows: progression of soft tissue lesions measured by computed tomography/magnetic resonance imaging as per response evaluation criteria in solid tumors (RECIST) 1.1; progression by bone lesions observed by bone scan and based on PCWG3. As per criteria, any bone progression must be confirmed by a subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan will be baseline to which all subsequent scans will be compared to determine progression. Participants whose confirmatory scan shows >=2 new lesions will be considered to have bone scan progression and participants whose confirmatory scans did not show >= 2 new lesions will not be considered to have bone scan progression when compared to Week 8 scan.

Secondary Outcome Measures :

1. Cohort 1: Overall survival (OS) [ Time Frame: Up to 66 months ]
   OS is defined as the time from date of randomization to date of death from any cause.
2. Cohort 1: Time to Symptomatic Progression [ Time Frame: Up to 28 months ]
   Time to symptomatic progression is defined as the need to initiate/record any of the following; a. the use of external beam radiation therapy (EBRT) for skeletal symptoms; b. the need for tumor-related orthopedic surgical intervention; c. other cancer-related procedures (for example: nephrostomy insertion, bladder catheter insertion, EBRT, or surgery for tumor symptoms other than skeletal); d. cancer-related morbid events (for example: fracture [symptomatic and/or pathologic, cord compression, urinary obstructive events); e. initiation of new systemic anti-cancer therapy because of cancer pain.
3. Cohort 1: Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: Up to 28 months ]
   Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
4. Cohort 1: Observed Plasma Concentrations of Niraparib [ Time Frame: Cycle 2 to 7; Each Cycle is of 28 days (Up to 7 months) ]
   Observed plasma concentrations of niraparib with descriptive statistics will be reported.
5. Cohort 1: Observed Trough Plasma Concentrations of Abiraterone [ Time Frame: Cycles 2 and 3; Each Cycle is of 28 days (Up to 3 months) ]
   Observed trough plasma concentrations of abiraterone with descriptive statistics will be reported.
6. Cohort 1: Number of Participants with Treatment-Emergent Adverse events (TEAEs) [ Time Frame: Up to 66 months ]
   An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention. AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. TEAEs are those events that occur or worsen on or after first dose of study drug through 30 days after last dose of study drug.
7. Cohort 1: Number of Participants with Treatment-Emergent Adverse events by Severity [ Time Frame: Up to 66 months ]
   Adverse event is any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. TEAEs are those events that occur or worsen on or after first dose of study drug through 30 days after last dose of study drug. Severity criteria includes grades: 1) Mild: easily tolerated, causing minimal discomfort and no interference with everyday activities; 2) Moderate: sufficient discomfort to cause interference with normal activity; 3) Severe: extreme distress, significant impairment of functioning/incapacitation. Prevents everyday activities; 4) Life-threatening: urgent intervention indicated and 5) Death.
8. Cohort 1: Number of Participants with Laboratory Abnormalities as Measure of Safety [ Time Frame: Up to 66 months ]
   Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• HRR gene alteration (as identified by the sponsor's required assays) as follows:

  1. Cohort 1: positive for HRR gene alteration
  2. Cohort 2: not positive for DRD (that is, HRR gene alteration)
  3. 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

Contacts and Locations

Locations

United States, Alabama

Urology Centers Of Alabama

Homewood, Alabama, United States, 35209

United States, Arizona

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

Urological Associates of Southern Arizona, P.C.

Tucson, Arizona, United States, 85741

United States, Arkansas

Arkansas Urology

Little Rock, Arkansas, United States, 72211

United States, California

Kaiser Permanente

Riverside, California, United States, 92505

San Bernardino Urological Associates

San Bernardino, California, United States, 92404

University of California San Francisco

San Francisco, California, United States, 94158

Sansum Clinic Pharm

Santa Barbara, California, United States, 93105

United States, Colorado

The Urology Center of Colorado

Denver, Colorado, United States, 80211

Colorado Clinical Research

Lakewood, Colorado, United States, 80228

United States, Connecticut

VA Connecticut Healthcare

West Haven, Connecticut, United States, 06516

United States, Florida

Bay Pines VA Healthcare System

Bay Pines, Florida, United States, 33744

Advanced Urology Institute

Daytona Beach, Florida, United States, 32114

University of Florida

Jacksonville, Florida, United States, 32209

Mayo Clinic - Division Of Hematology/oncology

Jacksonville, Florida, United States, 32224

United States, Illinois

Veterans Affairs Medical Ctr

Hines, Illinois, United States, 60141

United States, Indiana

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States, 46825

First Urology

Jeffersonville, Indiana, United States, 47130

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

United States, Kentucky

Norton Healthcare

Louisville, Kentucky, United States, 40202

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Maryland

Rcca Md, Llc

Bethesda, Maryland, United States, 20817

Chesapeake Urology Research Associates

Towson, Maryland, United States, 21204

United States, Massachusetts

Massachusetts General

Boston, Massachusetts, United States, 02114

United States, Michigan

Michigan Institute of Urology

Troy, Michigan, United States, 48084

United States, Missouri

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States, 64128

United States, Nebraska

Adult Pediatric Urology & Urogynecology, P.C

Omaha, Nebraska, United States, 68114

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

United States, New Jersey

Delaware Valley Urology, LLC

Mount Laurel, New Jersey, United States, 08054

United States, New York

New York Oncology Hematology

Albany, New York, United States, 12208

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

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Upstate Cancer Center

Syracuse, New York, United States, 13210

United States, Ohio

Clinical Research Solutions, LLC

Middleburg Heights, Ohio, United States, 44130

United States, Oregon

Oregon Urology Institute

Springfield, Oregon, United States, 97477

United States, Pennsylvania

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States, 19004

Lancaster Urology

Lancaster, Pennsylvania, United States, 17604

VA Pittsburgh

Pittsburgh, Pennsylvania, United States, 15240

United States, South Carolina

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

United States, Tennessee

Urology Associates

Nashville, Tennessee, United States, 37209

United States, Texas

Houston Metro Urology

Houston, Texas, United States, 77027

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Utah

Utah Cancer Specialists

Salt Lake City, Utah, United States, 84106

United States, Virginia

Salem VA Medical Center

Salem, Virginia, United States, 80113

Urology of Virginia, PLCC

Virginia Beach, Virginia, United States, 23462

United States, Washington

NorthWest Medical Specialties, PLLC

Tacoma, Washington, United States, 98405

Argentina

Hospital Aleman

Buenos Aires, Argentina, C1118AAT

Centro de Urologia (CDU)

Ciudad Automoma Buenos Aires, Argentina, C1120AAT

CEMIC Saavedra

Ciudad Autonoma de Buenos Aires, Argentina, C1431FWN

Centro Oncológico Korben

Ciudad Autónoma de Buenos Aires, Argentina, C1426AGE

Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Cordoba, Argentina, 5000

Hospital Privado - Centro Medico de Cordoba

Cordoba, Argentina, X5016KEH

Instituto de Investigaciones Clinicas Mar del Plata

Mar Del Plata, Buenos Aires, Argentina, B7600FZN

Hospital Privado de Comunidad

Mar Del Plata, Argentina, B7602CBM

Centro de Investigacion Pergamino SA

Pergamino, Argentina, B2700CPM

Sanatorio Britanico de Rosario

Rosario, Argentina, 2000

Sanatorio Parque

Rosario, Argentina, S2000SDV

ARS Médica

San Salvador De Jujuy, Argentina, Y4600AFW

Australia

Royal Adelaide Hospital

Adelaide, Australia, 5000

Pindara Private Hospital

Benowa, Australia, 4217

Sunshine Coast University Hospital

Birtinya, Australia, 4575

Princess Alexandra Hospital

Brisbane, Australia, 4102

St. Vincent's Hospital Sydney

Darlinghurst, Australia, 2010

Royal Hobart Hospital

Hobart, Australia, 7000

Macquarie University

Macquarie University, Australia, 2109

Eye Surgery Associates

Malvern, Australia, 3144

Peter MacCallum Cancer Centre

Melbourne, Australia, 3000

Fiona Stanley Hospital

Murdoch, Australia, 6150

Hollywood Private Hospital

Nedlands, Australia, 6009

Prince Of Wales Hospital

Randwick, Australia, 2031

Sydney Adventist Hospital

Wahroonga, Australia, 2076

Wollongong Private Hospital

Wollongong, Australia, 2500

Belgium

OLV Ziekenhuis Aalst

Aalst, Belgium, 9300

ZNA Middelheim

Antwerpen, Belgium, 2020

Grand Hôpital de Charleroi, site Notre Dame

Charleroi, Belgium, 6000

AZ Maria Middelares

Gent, Belgium, 9000

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liege, Belgium, B-4000

ZNA Jan Palfijn

Merksem, Belgium, 2170

Brazil

Hospital Do Cancer De Barretos - Fundacao Pio Xii

Barretos, Brazil, 14784-400

PERSONAL - Oncologia de Precisão e Personalizada

Belo Horizonte, Brazil, 30130-090

Hospital Sírio Libanes Unidade Brasilia

Brasilia, Brazil, 70200-730

CIONC - Centro Integrado de Oncologia de Curitiba

Curitiba, Brazil, 80810-050

Pronutrir

Fortaleza, Brazil, 60 810180

Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

Goiânia, Brazil, 74605-070

Hospital de Caridade de Ijui - CACON

Ijui, Brazil, 98700-000

Fundação São Francisco Xavier

Ipatinga, Brazil, 35162 189

Instituto Joinvilense De Hematologia e Oncologia

Joinville, Brazil, 89201260

Centro de Tratamento de câncer Medradius

Maceió, Brazil, 57052-765

Liga Norte Riograndense Contra O Cancer

Natal, Brazil, 59062-000

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90020-090

Hospital Ernesto Dornelles

Porto Alegre, Brazil, 90160-093

Instituto Nacional do Cancer - INCA

Rio de Janeiro, Brazil, 20230-130

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Brazil, 20551-030

Oncoclínicas

Rio De Janeiro, Brazil, 22250-905

Instituto COI de Pesquisa, Educacao e Gestao

Rio de Janeiro, Brazil, 22793-080

Hospital Santa Isabel

Salvador, Brazil, 40050-410

CEPHO - Faculdade de Medicina do ABC

Santo André, Brazil, 09060-870

Santa Casa de Misericordia de São Paulo

Sao Paulo, Brazil, 01221-020

Instituto de Ensino E Pesquisa Sao Lucas

Sao Paulo, Brazil, 01236-030

ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA

Sao Paulo, Brazil, 01246-000

Hospital Alemão Oswaldo Cruz

Sao Paulo, Brazil, 01421-000

Fundacao Antonio Prudente

Sao Paulo, Brazil, 01509900

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, Brazil, 18030-005

Núcleo de Pesquisa São Camilo

São Paulo, Brazil, 04014-002

Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO

São Paulo, Brazil, 04039-004

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, Brazil, 04502-001

Instituto do Cancer De Tres Lagoas

Três Lagoas, Brazil, 79601-001

Bulgaria

MHAT Deva Maria

Burgas, Bulgaria, 8001

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Bulgaria, 5800

Complex Oncology Center - Plovdiv EOOD

Plovdiv, Bulgaria, 4004

Specialized Hospital for Active Treatment in Oncology EAD

Sofia, Bulgaria, 1756

SHATOD 'Dr. Marko Antonov Markov'

Varna, Bulgaria, 9010

Comprehensive Cancer Center

Vratsa, Bulgaria, 3001

Canada, Alberta

Southern Alberta Institute of Urology / Prostate Cancer Centre

Calgary, Alberta, Canada, T2V 1P9

Canada, British Columbia

British Columbia Cancer Agency (BCCA) - Vancouver Centre

Vancouver, British Columbia, Canada, V5Z 4E6

British Columbia Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, Canada, V8R 6V5

Canada, Ontario

McMaster Institute of Urology

Hamilton, Ontario, Canada, L8N 4A6

Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)

Kingston, Ontario, Canada, K7L 3N6

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada, M4N 3M5

University Health Network (UHN) Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

Centre de Recherche du CHUM

Montreal, Quebec, Canada, H2X 0A9

Canada, Saskatchewan

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada, S7N 4H4

China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China, 100021

Peking University First Hospital

Beijing, China, 100034

Beijing Friendship Hospital

Beijing, China, 100050

Beijing Cancer Hospital of Peking University

Beijing, China, 100142

Peking University Third Hospital

Beijing, China, 100191

Beijing Hospital

BeiJing, China, 100730

Sichuan Provincial People's Hospital

Chengdu, China, 610072

Southwest Hospital, The Third Military Medical University

Chongqing, China, 400025

Chongqing University Cancer Hospital

Chongqing, China, 400030

Fujian Medical University Union Hospital

Fuzhou, China, 350001

Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Guangzhou, China, 510120

Guangzhou First Municipal People's Hospital

GuangZhou, China, 510180

Nanjing Drum Tower Hospital

Nanjing, China, 210008

Jiangsu Cancer Hospital

Nanjing, China, 210009

Drug clinical trial ethics committee of Ningbo First Hospital

Ningbo, China, 315010

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Huashan Hospital Fudan University

Shanghai, China, 200040

ShangHai Huadong Hospital

ShangHai, China, 200040

Renji Hospital, Shanghai Jiaotong University School of Medicine

ShangHai, China, 200127

The Fifth People's Hospital of Shanghai, Fudan University

ShangHai, China, 200240

The First Affiliated Hospital of Soochow University

Suzhou, China, 215006

Tianjin Medical University Cancer Hospital

Tianjin, China, 300060

The Central Hospital of Wuhan

Wuhan, China, 430014

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

Wuhan, China, 430030

Wuxi People's Hospital

Wuxi, China, 214023

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králove, Czechia, 500 05

Krajská nemocnice Liberec

Liberec, Czechia, 460 63

Uromedical Center s.r.o.

Olomouc, Czechia, 77900

Multiscan s.r.o.

Pardubice, Czechia, 53203

Fakultni nemocnice Plzen, Urologicka klinika

Plzen, Czechia, 305 99

Urologicka klinika 1.LF UK a VFN

Praha 2, Czechia, 120 00

Thomayerova nemocnice, Onkologicka klinika

Praha 4, Czechia, 140 59

Uherskohradistska nemocnice a.s.

Uherske Hradiste, Czechia, 68668

France

CHRU De Besancon

Besancon, France, 25030

Institut Bergonié

Bordeaux, France, 33000

Centre Jean Perrin

Clermont Ferrand, France, 63011

Centre Leon Bérard

Lyon, France, 69008

Institut Regional du Cancer de Montpellier Val d'Aurelle

Montpellier, France, 34298

Polyclinique de Gentilly

Nancy, France, 54100

Centre Antoine Lacassagne

Nice Cedex 2, France, 06189

Hopital Europeen Georges-Pompidou

Paris Cedex 15, France, 75908

Institut de Cancérologie de l'Ouest (ICO)

Saint Herblain, France, 44805

HIA Begin

Saint Mande, France, 94163

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg Cedex, France, 67098

Germany

Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

Braunschweig, Germany, 38126

Urologicum Duisburg

Duisburg, Germany, 47179

Universitätsklinikum des Saarlandes

Homburg, Germany, 66424

Universitätsklinikum Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany, 39120

Universitaetsklinikum Muenster

Muenster, Germany, 48149

Studienpraxis Urologie Drs. Feyerabend

Nuertingen, Germany, 72622

Hungary

Semmelweis Egyetem, Urológia Klinika

Budapest, Hungary, 1082

Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

Budapest, Hungary, 1122

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, Hungary, 5700

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz

Nyiregyhaza, Hungary, 4400

Uro-Clin Kft.

Pécs, Hungary, 7621

Szegedi Tudomanyegyetem

Szeged, Hungary, 6720

Szegedi Tudomanyegyetem

Szeged, Hungary, 6725

Markusovszky Egyetemi Oktatokorhaz

Szombathely, Hungary, 9700

Israel

Asaf Harofe Medical Center

Beer Yaakov, Israel, 60930

Rambam Health Care Campus

Haifa, Israel, 31096

Rabin Medical Center

Petah Tikva, Israel, 49100

Sheba Medical Center Tel Hashomer

Ramat Gan, Israel, 52621

Italy

AUSL Romagna - Ospedale di Faenza

Faenza, Italy, 48018

Ospedale San Raffaele

Milano, Italy, 20132

ASST Grande Ospedale Metropolitano Niguarda

Milano, Italy, 20162

Oncologia Medica A - Ist Naz Tumori G Pascale

Napoli, Italy, 80131

Istituto Oncologico Veneto Iov Irccs Padova

Padova, Italy, 35128

Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma

Parma, Italy, 43126

Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

Perugia, Italy, 06132

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, 56126

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy, 00168

Campus Bio-Medico di Roma

Roma, Italy, 128

Azienda Ospedaliera S. Maria Terni

Terni, Italy, 5100

A.O.U. Città della Salute e della Scienza

Torino, Italy, 10126

Ospedale Santa Chiara Trento

Trento, Italy, 38122

Korea, Republic of

Pusan National University Hospital

Busan, Korea, Republic of, 49241

Kyungpook National University Chilgok Hospital

Daegu, Korea, Republic of, 41404

Keimyung University Dongsan Hospital

Daegu, Korea, Republic of, 42601

Chungnam National University Hospital

Daejeon, Korea, Republic of, 35015

Chonnam National University Hospital

Gwangju, Korea, Republic of, 61469

National Cancer Center

Gyeonggi-do, Korea, Republic of, 10408

Ajou University Hospital

Gyeonggi-do, Korea, Republic of, 443-721

Seoul National University Bundang Hospital

Seongnam-si, Korea, Republic of, 13620

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 06273

Samsung Medical Center

Seoul, Korea, Republic of, 06351

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 06591

Malaysia

Hospital Pulau Pinang

George Town, Malaysia, 10990

Hospital Sultan Ismail

Johor Bahru, Malaysia, 81100

Hospital Likas

Kota Kinabalu, Malaysia, 88996

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 59100

Sarawak General Hospital

Kuching, Malaysia, 93586

Mexico

iBiomed Research Unit

Aguascalientes, Mexico, 20010

Mexico Centre for Clinical Research, S.A. de C.V.

Ciudad de Mexico, Mexico, 03100

Consultorio de Especialidad en Urologia Privado

Durango, Mexico, 34000

Avix Investigacion Clinica, S.C.

Monterrey, Mexico, 64710

Consultorio Privado

Zapopan, Mexico, 45040

Netherlands

NKI-AVL, Amsterdam

Amsterdam, Netherlands, 1066 CX

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

MC Haaglanden Lok Antoniushove - Afd.Interne - INT

Leidschendam, Netherlands, 2262 BA

St. Antonius Ziekenhuis (St. Antonius Hospital)

Nieuwegein, Netherlands, 3430EM

Canisius-Wilhelminaziekenhuis

Nijmegen, Netherlands, 6532 SZ

Erasmus MC

Rotterdam, Netherlands, 3075 EA

Zuyderland Medical Center

Sittard-Geleen, Netherlands, 6162 BG

Poland

Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

Bydgoszcz, Poland, 85-094

Centrum Onkologii im. Prof. F. Lukaszczyka

Bydgoszcz, Poland, 85-796

Uniwersyteckie Centrum Kliniczne

Gdańsk, Poland, 80-214

Szpitale Pomorskie Sp. z o.o.

Gdynia, Poland, 81-519

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, Poland, 93-509

Urologica Praktyka Lekarska Adam Marcheluk

Siedlce, Poland, 08-110

Pomorski Uniwersytet Medyczny w Szczecinie

Szczecin, Poland, 70-111

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warszawa, Poland, 02-781

Dolnoslaskie Centrum Onkologii

Wrocław, Poland, 53-413

Portugal

Hospitais da universidade de Coimbra

Coimbra, Portugal, 3000-075

Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

Coimbra, Portugal, 3000-075

Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

Lisboa, Portugal, 1649-035

Champalimaud Foundation Champalimaud Centre

Lisbon, Portugal, 1400-038

H. Santo António - Centro Hospitalar do Porto

Porto, Portugal, 4099-001

Puerto Rico

VA Caribbean Healthcare System

San Juan, Puerto Rico, 00921

Russian Federation

Altai Regional Oncology Dispensary

Barnaul, Russian Federation, 656045

Ivanovo Regional Oncology Dispensary

Ivanovo, Russian Federation, 153040

GUZ Kursk Regional Oncology Dispensary

Kursk, Russian Federation, 305524

Russian Scientific Center of Roentgenoradiology

Moscow, Russian Federation, 117997

Moscow City Clinical Hospital # 62

Moscow, Russian Federation, 125130

Clinical Diagnostic Centre of Nizhny Novgorod Region

Nizhny Novgorod, Russian Federation, 603000

Clinical Oncology Dispensary

Omsk, Russian Federation, 644013

LLC Novaya Clinica

Pyatigorsk, Russian Federation, 357500

Pyatigorsk Regional Oncology Dispensary

Pyatigorsk, Russian Federation, 357502

Private Medical Institution Euromedservice

Saint Petersburg, Russian Federation, 196603

Leningrad Regional Oncology Dispensary

Saint-Petersburg, Russian Federation, 191104

Russian Scientific Center of Radiology and Surgical Technologies

Sankt-Peterburg, Russian Federation, 197758

Republican Oncology Dispensary

Saransk, Russian Federation, 430032

Oncologic Dispensary No.2

Sochi, Russian Federation, 354057

Tambov Regional Oncology Clinical Dispansary

Tambov, Russian Federation, 392013

Tomsk Cancer Research Institute

Tomsk, Russian Federation, 634050

Medical-sanitary unit 'Neftyanik'

Tyumen, Russian Federation, 625000

Vologda Regional Oncological Dispensary

Vologda, Russian Federation, 160012

South Africa

Clinresco Centres Pty Ltd

Johannesburg, South Africa, 1619

Clinical Research Unit

Pretoria, South Africa, 0001

Spain

Hosp. Del Mar

Barcelona, Spain, 08003

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain, 08025

Hosp. Clinic I Provincial de Barcelona

Barcelona, Spain, 08036

Hospital Juan Canalejo

Coruña, Spain, 15006

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain, 11407

Hosp. Univ. Ramon Y Cajal

Madrid, Spain, 28034

Hosp. Clinico San Carlos

Madrid, Spain, 28040

Hosp. Virgen de La Victoria

Málaga, Spain, 29010

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcon, Spain, 28223

Corporacio Sanitari Parc Tauli

Sabadell, Spain, 08208

Hosp. Univ. Marques de Valdecilla

Santander, Spain, 39008

Hosp. Univ. I Politecni La Fe

Valencia, Spain, 46026

Sweden

Södersjukhuset

Stockholm, Sweden, 11883

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden, 171 76

Akademiska Sjukhuset

Uppsala, Sweden, 751 85

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

China Medical University Hospital

Taichung, Taiwan, 403

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Tungs' Taichung MetroHarbor Hospital

Taichung, Taiwan, 435

Chi Mei Medical Center - Yong Kang

Tainan, Taiwan, 710

National Taiwan University Hospital

Taipei, Taiwan, 100

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 33305

Turkey

Cukurova University, Faculty of Medicine

Adana, Turkey, 01330

Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey, 06200

Ankara Sehir Hastanesi

Ankara, Turkey, 6560

Akdeniz University Medical Faculty

Antalya, Turkey, 07070

Trakya University Medical Faculty

Edirne, Turkey, 22030

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey, 34096

Bakirkoy Training and Research Hospital

Istanbul, Turkey, 34147

Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey, 34722

Izmir Medical Park Hospital

Izmir, Turkey, 35575

Kocaeli University Medical Faculty

Kocaeli, Turkey, 41380

Ukraine

Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

Cherkasy, Ukraine, 18009

Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

Dnipo, Ukraine, 49005

Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

Dnipro, Ukraine, 49100

Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

Dnipro, Ukraine, 49102

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, Ukraine, 76008

Municipal non-profit enterprise 'Regional Center of Oncology'

Khakhiv, Ukraine, 61070

Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval

Kharkiv, Ukraine, 61037

State Institution National Cancer Institute

Kyiv, Ukraine, 03022

State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

Kyiv, Ukraine, 03115

Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

Lviv, Ukraine, 79010

ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

Poltava, Ukraine, 36024

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

Uzhgorod, Ukraine, 88000

United Kingdom

Royal Blackburn Hospital

Blackburn, United Kingdom, BB2 3HH

Royal Lancaster Infirmary

Lancaster, United Kingdom, LA1 4RP

UCL Cancer Institute

London, United Kingdom, WC1E 6DD

Torbay Hospital-Devon

Torquay, United Kingdom, TQ2 7AA

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

Truro, United Kingdom, TR1 3LJ

New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03748641
• Other Study ID Numbers: CR108534; 2017-003364-12 ( EudraCT Number ); 64091742PCR3001 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: November 21, 2018
• Last Update Posted: August 3, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Prednisone; Abiraterone Acetate; Niraparib; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors