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: Recruiting
• First Posted: November 21, 2018
• Last Update Posted: October 9, 2020
• 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 plus 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 4 phases: a prescreening phase for biomarker evaluation only, a screening phase, a treatment phase, and a follow up phase. 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)
• Estimated Enrollment: 1000 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
• Estimated Primary Completion Date: July 21, 2022
• Estimated Study Completion Date: February 25, 2025

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.	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.	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)
• 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

Contacts

Contact: Study Contact; 844-434-4210; JNJ.CT@sylogent.com

Locations

United States, Alabama

Urology Centers Of Alabama; Recruiting

Homewood, Alabama, United States, 35209

United States, Arizona

Mayo Clinic Arizona; Not yet recruiting

Phoenix, Arizona, United States, 85054

Urological Associates of Southern Arizona, P.C.; Recruiting

Tucson, Arizona, United States, 85741

United States, Arkansas

Arkansas Urology; Recruiting

Little Rock, Arkansas, United States, 72211

United States, California

Kaiser Permanente; Recruiting

Riverside, California, United States, 92505

San Bernardino Urological Associates; Recruiting

San Bernardino, California, United States, 92404

University of California San Francisco; Recruiting

San Francisco, California, United States, 94158

Sansum Clinic Pharm; Recruiting

Santa Barbara, California, United States, 93105

Kaiser Permanente Medical Center; Withdrawn

Vallejo, California, United States, 95119

United States, Colorado

The Urology Center of Colorado; Recruiting

Denver, Colorado, United States, 80211

Urology Associates of Denver; Withdrawn

Englewood, Colorado, United States, 80113

Foothills Urology - Golden Off; Recruiting

Golden, Colorado, United States, 80401-5027

United States, Connecticut

VA Connecticut Healthcare; Recruiting

West Haven, Connecticut, United States, 06516

United States, Florida

Bay Pines VA Healthcare System; Recruiting

Bay Pines, Florida, United States, 33744

Advanced Urology Institute; Recruiting

Daytona Beach, Florida, United States, 32114

University of Florida; Recruiting

Jacksonville, Florida, United States, 32209

Mayo Clinic - Division Of Hematology/oncology; Not yet recruiting

Jacksonville, Florida, United States, 32224

United States, Illinois

Veterans Affairs Medical Ctr; Recruiting

Hines, Illinois, United States, 60141

United States, Indiana

First Urology; Recruiting

Jeffersonville, Indiana, United States, 47130

United States, Kansas

University of Kansas Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

United States, Kentucky

Norton Healthcare; Recruiting

Louisville, Kentucky, United States, 40202

United States, Louisiana

Ochsner Clinic Foundation; Recruiting

New Orleans, Louisiana, United States, 70121

United States, Maryland

Rcca Md, Llc; Recruiting

Bethesda, Maryland, United States, 20817

Chesapeake Urology Research Associates; Recruiting

Towson, Maryland, United States, 21204

United States, Massachusetts

Massachusetts General; Recruiting

Boston, Massachusetts, United States, 02114

United States, Michigan

Michigan Institute of Urology; Recruiting

Troy, Michigan, United States, 48084

United States, Missouri

Kansas City Veterans Affairs Medical Center; Recruiting

Kansas City, Missouri, United States, 64128

United States, Nebraska

Adult Pediatric Urology & Urogynecology, P.C; Recruiting

Omaha, Nebraska, United States, 68114

Urology Cancer Center and GU Research Network; Withdrawn

Omaha, Nebraska, United States, 68130

United States, Nevada

Comprehensive Cancer Centers of Nevada; Recruiting

Las Vegas, Nevada, United States, 89169

United States, New Jersey

Delaware Valley Urology, LLC; Recruiting

Mount Laurel, New Jersey, United States, 08054

United States, New York

New York Oncology Hematology; Recruiting

Albany, New York, United States, 12208

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

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center; Recruiting

New York, New York, United States, 10065

Associated Medical Professionals of Ny; Withdrawn

Syracuse, New York, United States, 13210

Upstate Cancer Center; Recruiting

Syracuse, New York, United States, 13210

United States, Ohio

Clinical Research Solutions, LLC; Recruiting

Middleburg Heights, Ohio, United States, 44130

United States, Oregon

Oregon Urology Institute; Recruiting

Springfield, Oregon, United States, 97477

United States, Pennsylvania

Centers for Advanced Urology, LLC; d/b/a MidLantic Urology; Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Lancaster Urology; Recruiting

Lancaster, Pennsylvania, United States, 17604

VA Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15240

United States, South Carolina

Carolina Urologic Research Center; Recruiting

Myrtle Beach, South Carolina, United States, 29572

United States, Tennessee

Urology Associates; Recruiting

Nashville, Tennessee, United States, 37209

United States, Texas

Houston Metro Urology; Recruiting

Houston, Texas, United States, 77027

University of Texas MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

United States, Utah

Utah Cancer Specialists; Recruiting

Salt Lake City, Utah, United States, 84106

United States, Virginia

Salem VA Medical Center; Recruiting

Salem, Virginia, United States, 80113

Urology of Virginia, PLCC; Recruiting

Virginia Beach, Virginia, United States, 23462

United States, Washington

NorthWest Medical Specialties, PLLC; Recruiting

Tacoma, Washington, United States, 98405

Argentina

Hospital Aleman; Recruiting

Buenos Aires, Argentina, C1118AAT

Hospital Italiano de Buenos Aires; Withdrawn

C.a.b.a., Argentina, C1181ACF

Fundación CENIT para la Investigación en Neurociencias; Recruiting

Capital Federal, Argentina, CP 1125

Centro de Urologia (CDU); Completed

Ciudad Automoma Buenos Aires, Argentina, C1120AAT

CEMIC Saavedra; Recruiting

Ciudad Autonoma de Buenos Aires, Argentina, C1431FWN

Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica; Recruiting

Cordoba, Argentina, 5000

Hospital Privado - Centro Medico de Cordoba; Recruiting

Cordoba, Argentina, X5016KEH

Instituto de Investigaciones Clinicas Mar del Plata; Recruiting

Mar Del Plata, Argentina, B7600FZN

Hospital Privado de Comunidad; Recruiting

Mar Del Plata, Argentina, B7602CBM

Centro de Investigacion Pergamino SA; Recruiting

Pergamino, Argentina, B2700CPM

Sanatorio Britanico de Rosario; Recruiting

Rosario, Argentina, 2000

Sanatorio Parque; Recruiting

Rosario, Argentina, S2000SDV

ARS Médica; Recruiting

San Salvador De Jujuy, Argentina, Y4600AFW

Australia

Royal Adelaide Hospital; Recruiting

Adelaide, Australia, 5116

Pindara Private Hospital; Recruiting

Benowa, Australia, 4217

Sunshine Coast University Hospital; Recruiting

Birtinya, Australia, 4575

Princess Alexandra Hospital; Recruiting

Brisbane, Australia, 4102

Chris O'Brien Lifehouse; Withdrawn

Camperdown, Australia, 2050

St. Vincent's Hospital Sydney; Recruiting

Darlinghurst, Australia, 2010

Royal Hobart Hospital; Recruiting

Hobart, Australia, 7000

Macquarie University; Recruiting

Macquarie University, Australia, 2109

Cabrini Health; Recruiting

Malvern, Australia, 3144

Peter MacCallum Cancer Centre; Recruiting

Melbourne, Australia, 3000

Fiona Stanley Hospital; Recruiting

Murdoch, Australia, 6150

Hollywood Private Hospital; Recruiting

Nedlands, Australia, 6009

Prince Of Wales Hospital; Recruiting

Randwick, Australia, 2031

Sydney Adventist Hospital; Recruiting

Wahroonga, Australia, 2076

Wollongong Private Hospital; Recruiting

Wollongong, Australia, 2500

Belgium

OLV Ziekenhuis Aalst; Recruiting

Aalst, Belgium, 9300

ZNA Middelheim; Recruiting

Antwerpen, Belgium, 2020

Grand Hôpital de Charleroi, site Notre Dame; Recruiting

Charleroi, Belgium, 6000

AZ Maria Middelares; Recruiting

Gent, Belgium, 9000

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman; Recruiting

Liege, Belgium, B-4000

ZNA Jan Palfijn; Recruiting

Merksem, Belgium, 2170

Brazil

Hospital Do Cancer De Barretos - Fundacao Pio Xii; Recruiting

Barretos, Brazil, 14784-400

PERSONAL - Oncologia de Precisão e Personalizada; Recruiting

Belo Horizonte, Brazil, 30130-090

Hospital Sírio Libanes Unidade Brasilia; Recruiting

Brasilia, Brazil, 70200-730

CIONC - Centro Integrado de Oncologia de Curitiba; Recruiting

Curitiba, Brazil, 80810-050

Pronutrir; Recruiting

Fortaleza, Brazil, 60 810180

Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás; Recruiting

Goiânia, Brazil, 74605-070

Hospital de Caridade de Ijui - CACON; Recruiting

Ijui, Brazil, 98700-000

Fundação São Francisco Xavier; Recruiting

Ipatinga, Brazil, 35162 189

Clínica de Neoplasias Litoral Ltda.; Not yet recruiting

Itajai, Brazil, 88301-220

Instituto Joinvilense De Hematologia e Oncologia; Recruiting

Joinville, Brazil, 89201260

Centro de Tratamento de câncer Medradius; Recruiting

Maceió, Brazil, 57052-765

Liga Norte Riograndense Contra O Cancer; Recruiting

Natal, Brazil, 59075-740

Irmandade Santa Casa de Misericordia de Porto Alegre; Recruiting

Porto Alegre, Brazil, 90020-090

Hospital Ernesto Dornelles; Recruiting

Porto Alegre, Brazil, 90160-093

Instituto Nacional do Cancer - INCA; Recruiting

Rio de Janeiro, Brazil, 20230-130

Hospital Universitário Pedro Ernesto; Recruiting

Rio de Janeiro, Brazil, 20551-030

Oncoclínicas; Recruiting

Rio De Janeiro, Brazil, 22250-905

Instituto COI de Pesquisa, Educacao e Gestao; Recruiting

Rio de Janeiro, Brazil, 22793-080

Hospital Santa Isabel; Recruiting

Salvador, Brazil, 40050-410

CEPHO - Faculdade de Medicina do ABC; Recruiting

Santo André, Brazil, 09060-870

Santa Casa de Misericordia de São Paulo; Recruiting

Sao Paulo, Brazil, 01221-020

Instituto de Ensino E Pesquisa Sao Lucas; Recruiting

Sao Paulo, Brazil, 01236-030

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

Sao Paulo, Brazil, 01246-000

Hospital Alemão Oswaldo Cruz; Recruiting

Sao Paulo, Brazil, 01421-000

Fundacao Antonio Prudente; Recruiting

Sao Paulo, Brazil, 01509900

IBCC Instituto Brasileiro de Controle do Cancer; Recruiting

Sao Paulo, Brazil, 03102-002

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado; Recruiting

Sorocaba, Brazil, 18030-005

Hospital Samaritano de São Paulo; Not yet recruiting

São Paulo, Brazil, 01243-020

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

São Paulo, Brazil, 04039-004

Instituto D'Or de Pesquisa e Ensino (IDOR); Recruiting

São Paulo, Brazil, 04502-001

Instituto do Cancer De Tres Lagoas; Not yet recruiting

Três Lagoas, Brazil, 79601-001

Instituto do Cancer De Tres Lagoas; Withdrawn

Três Lagoas, Brazil, 79603110

Bulgaria

MHAT Deva Maria; Recruiting

Burgas, Bulgaria, 8001

UMHAT 'Dr. Georgi Stranski', EAD; Recruiting

Pleven, Bulgaria, 5800

Complex Oncology Center - Plovdiv EOOD; Recruiting

Plovdiv, Bulgaria, 4004

Specialized Hospital for Active Treatment in Oncology EAD; Recruiting

Sofia, Bulgaria, 1756

SHATOD 'Dr. Marko Antonov Markov'; Recruiting

Varna, Bulgaria, 9010

Comprehensive Cancer Center; Recruiting

Vratsa, Bulgaria, 3001

Canada, Alberta

Southern Alberta Institute of Urology / Prostate Cancer Centre; Recruiting

Calgary, Alberta, Canada, T2V 1P9

Canada, British Columbia

British Columbia Cancer Agency (BCCA) - Vancouver Centre; Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

British Columbia Cancer Agency - Vancouver Island Centre; Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Canada, Ontario

McMaster Institute of Urology; Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre); Recruiting

Kingston, Ontario, Canada, K7L 3N6

Sunnybrook Health Sciences Center; Recruiting

Toronto, Ontario, Canada, M4N 3M5

University Health Network (UHN) Princess Margaret Cancer Centre; Recruiting

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

Centre de Recherche du CHUM; Recruiting

Montreal, Quebec, Canada, H2X 0A9

Canada, Saskatchewan

Saskatoon Cancer Centre; Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

China

Cancer Hospital Chinese Academy of Medical Sciences; Recruiting

Beijing, China, 100021

Peking University First Hospital; Recruiting

Beijing, China, 100034

Beijing Friendship Hospital; Recruiting

Beijing, China, 100050

Beijing Cancer Hospital of Peking University; Recruiting

Beijing, China, 100142

Peking University Third Hospital; Recruiting

Beijing, China, 100191

Beijing Hospital; Recruiting

BeiJing, China, 100730

Sichuan Provincial People's Hospital; Not yet recruiting

Chengdu, China, 610072

Southwest Hospital, The Third Military Medical University; Not yet recruiting

Chongqing, China, 400025

Chongqing Cancer hospital; Not yet recruiting

Chongqing, China, 400030

Fujian Medical University Union Hospital; Recruiting

Fuzhou, China, 350001

Sun Yat-Sen Memorial Hospital Sun Yat-sen University; Not yet recruiting

Guangzhou, China, 510120

Guangzhou First Municipal People's Hospital; Recruiting

GuangZhou, China, 510180

The First Affiliated hospital of Anliui Medical University; Not yet recruiting

Hefei, China

Nanjing Drum Tower Hospital; Not yet recruiting

Nanjing, China, 210008

Jiangsu Cancer Hospital; Not yet recruiting

Nanjing, China, 210009

Drug clinical trial ethics committee of Ningbo First Hospital; Not yet recruiting

Ningbo, China, 315010

Fudan University Shanghai Cancer Center; Recruiting

Shanghai, China, 200032

Shanghai Zhongshan Hospital; Not yet recruiting

ShangHai, China, 200032

Huashan Hospital Fudan University; Recruiting

Shanghai, China, 200040

ShangHai Huadong Hospital; Recruiting

ShangHai, China, 200040

Renji Hospital, Shanghai Jiaotong University School of Medicine; Not yet recruiting

ShangHai, China, 200127

The Fifth People's Hospital of Shanghai, Fudan University; Not yet recruiting

ShangHai, China, 200240

The First Affiliated Hospital of Soochow University; Recruiting

Suzhou, China, 215006

Tianjin Medical University Cancer Hospital; Not yet recruiting

Tianjin, China, 300060

The Central Hospital of Wuhan; Recruiting

Wuhan, China, 430014

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

Wuhan, China, 430030

Wuxi People's Hospital; Not yet recruiting

Wuxi, China, 214023

First Affiliated Hospital, Xi'an Jiaotong University; Recruiting

Xi'an, China, 710061

Czechia

Komplexni onkologicke centrum Multiscan s.r.o.; Not yet recruiting

Horovice, Czechia, 26831

Fakultni nemocnice Hradec Kralove; Recruiting

Hradec Králove, Czechia, 500 05

Krajská nemocnice Liberec; Recruiting

Liberec, Czechia, 460 63

Uromedical Center s.r.o.; Recruiting

Olomouc, Czechia, 77900

Multiscan s.r.o.; Recruiting

Pardubice, Czechia, 53203

Fakultni nemocnice Plzen, Urologicka klinika; Recruiting

Plzen, Czechia, 305 99

Urologicka klinika 1.LF UK a VFN; Recruiting

Praha 2, Czechia, 120 00

Thomayerova nemocnice, Onkologicka klinika; Recruiting

Praha 4, Czechia, 140 59

Uherskohradistska nemocnice a.s.; Not yet recruiting

Uherske Hradiste, Czechia, 68668

France

CHRU De Besancon; Recruiting

Besancon, France, 25030

Institut Bergonié; Recruiting

Bordeaux, France, 33000

Centre Jean Perrin; Recruiting

Clermont Ferrand, France, 63011

Centre Leon Bérard; Recruiting

Lyon, France, 69008

Institut Regional du Cancer de Montpellier Val d'Aurelle; Recruiting

Montpellier, France, 34298

Polyclinique de Gentilly; Recruiting

Nancy, France, 54100

Centre Antoine Lacassagne; Recruiting

Nice Cedex 2, France, 06189

Hopital Europeen Georges-Pompidou; Recruiting

Paris Cedex 15, France, 75908

Institut de Cancérologie de l'Ouest (ICO); Recruiting

Saint Herblain, France, 44805

HIA Begin; Recruiting

Saint Mande, France, 94163

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre; Recruiting

Strasbourg Cedex, France, 67098

Germany

Charite - Universitatsmedizin Berlin (CCM); Withdrawn

Berlin, Germany, 12200

Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer; Recruiting

Braunschweig, Germany, 38126

Urologicum Duisburg; Recruiting

Duisburg, Germany, 47179

Universitatsklinikum Essen; Withdrawn

Essen, Germany, 45147

Universitätsklinikum des Saarlandes; Recruiting

Homburg, Germany, 66424

Klinik und Poliklinik für Urologie; Withdrawn

Köln, Germany, 50937

Universitätsklinikum Otto-von-Guericke-Universität Magdeburg; Recruiting

Magdeburg, Germany, 39120

Universitaetsklinikum Muenster; Recruiting

Muenster, Germany, 48149

Studienpraxis Urologie Drs. Feyerabend; Recruiting

Nuertingen, Germany, 72622

Hungary

Semmelweis Egyetem, Urológia Klinika; Recruiting

Budapest, Hungary, 1082

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

Budapest, Hungary, 1122

Szent János Kórház és Észak-budai Egyesített Kórházak; Withdrawn

Budapest, Hungary, 1125

Debreceni Egyetem Klinikai Kozpont; Recruiting

Debrecen, Hungary, 4032

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz; Recruiting

Gyula, Hungary, 5700

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

Nyiregyhaza, Hungary, 4400

Uro-Clin Kft.; Completed

Pécs, Hungary, 7621

Szegedi Tudomanyegyetem; Recruiting

Szeged, Hungary, 6720

Szegedi Tudomanyegyetem; Recruiting

Szeged, Hungary, 6725

Markusovszky Egyetemi Oktatokorhaz; Recruiting

Szombathely, Hungary, 9700

Israel

Asaf Harofe Medical Center; Recruiting

Beer Yaakov, Israel, 60930

Rambam Health Care Campus; Recruiting

Haifa, Israel, 31096

Rabin Medical Center; Recruiting

Petah Tikva, Israel, 49100

Sheba Medical Center Tel Hashomer; Recruiting

Ramat Gan, Israel, 52621

Italy

AUSL Romagna - Ospedale di Faenza; Recruiting

Faenza, Italy, 48018

Ospedale San Raffaele; Recruiting

Milano, Italy, 20132

ASST Grande Ospedale Metropolitano Niguarda; Recruiting

Milano, Italy, 20162

Oncologia Medica A - Ist Naz Tumori G Pascale; Recruiting

Napoli, Italy, 80131

Istituto Oncologico Veneto Iov Irccs Padova; Recruiting

Padova, Italy, 35128

Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma; Recruiting

Parma, Italy, 43126

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

Perugia, Italy, 06132

Azienda Ospedaliero Universitaria Pisana; Recruiting

Pisa, Italy, 56126

Fondazione Policlinico Universitario A. Gemelli IRCCS; Recruiting

Roma, Italy, 00168

Campus Bio-Medico di Roma; Recruiting

Roma, Italy, 128

Azienda Ospedaliera S. Maria Terni; Recruiting

Terni, Italy, 5100

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

Torino, Italy, 10126

Ospedale Santa Chiara Trento; Recruiting

Trento, Italy, 38122

Korea, Republic of

Pusan National University Hospital.; Recruiting

Busan, Korea, Republic of, 49241

Kyungpook National University Chilgok Hospital; Recruiting

Daegu, Korea, Republic of, 41404

Keimyung University Dongsan Hospital; Recruiting

Daegu, Korea, Republic of, 42601

Chungnam National University Hospital; Recruiting

Daejeon, Korea, Republic of, 35015

National Cancer Center; Recruiting

Goyang-Si, Korea, Republic of, 10408

Chonnam National University Hospital; Recruiting

Gwangju, Korea, Republic of, 61469

Seoul National University Bundang Hospital; Recruiting

Seongnam-si, Korea, Republic of, 13620

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Severance Hospital; Recruiting

Seoul, Korea, Republic of, 03722

Gangnam Severance Hospital; Recruiting

Seoul, Korea, Republic of, 06273

Samsung Medical Center; Recruiting

Seoul, Korea, Republic of, 06351

Seoul St. Mary's Hospital; Recruiting

Seoul, Korea, Republic of, 06591

Asan Medical Center; Recruiting

Seoul, Korea, Republic of, 5505

Ajou University Hospital; Recruiting

Suwon, Korea, Republic of, 443-721

Malaysia

Hospital Pulau Pinang; Recruiting

George Town, Malaysia, 10990

Hospital Sultan Ismail; Recruiting

Johor Bahru, Malaysia, 81100

Hospital Likas; Recruiting

Kota Kinabalu, Malaysia, 88996

Hospital Kuala Lumpur; Recruiting

Kuala Lumpur, Malaysia, 50586

University Malaya Medical Centre; Recruiting

Kuala Lumpur, Malaysia, 59100

Sarawak General Hospital; Recruiting

Kuching, Malaysia, 93586

Mexico

iBiomed Research Unit; Recruiting

Aguascalientes, Mexico, 20010

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

Ciudad de Mexico, Mexico, 03100

Consultorio de Especialidad en Urologia Privado; Recruiting

Durango, Mexico, 34000

Centro Medico Nacional Siglo XXI IMSS; Withdrawn

Mexico, Mexico, 06720

Avix Investigacion Clinica, S.C.; Recruiting

Monterrey, Mexico, 64710

Consultorio Privado; Recruiting

Zapopan, Mexico, 45040

Netherlands

NKI-AVL, Amsterdam; Recruiting

Amsterdam, Netherlands, 1066 CX

Universitair Medisch Centrum Groningen; Recruiting

Groningen, Netherlands, 9713 GZ

MC Haaglanden Lok Antoniushove - Afd.Interne - INT; Recruiting

Leidschendam, Netherlands, 2262 BA

St. Antonius Ziekenhuis (St. Antonius Hospital); Recruiting

Nieuwegein, Netherlands, 3430EM

Canisius-Wilhelminaziekenhuis; Recruiting

Nijmegen, Netherlands, 6532 SZ

Erasmus MC; Recruiting

Rotterdam, Netherlands, 3075 EA

Zuyderland Medical Center; Recruiting

Sittard-Geleen, Netherlands, 6162 BG

Poland

Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza; Recruiting

Bydgoszcz, Poland, 85-094

Centrum Onkologii im. Prof. F. Lukaszczyka; Recruiting

Bydgoszcz, Poland, 85-796

Uniwersyteckie Centrum Kliniczne; Recruiting

Gdańsk, Poland, 80-214

Szpitale Pomorskie Sp. z o.o.; Recruiting

Gdynia, Poland, 81-519

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi; Recruiting

Lodz, Poland, 93-509

Wielkopolskie Centrum Onkologii; Withdrawn

Poznan, Poland, 61-866

Urologica Praktyka Lekarska Adam Marcheluk; Recruiting

Siedlce, Poland, 08-110

Pomorski Uniwersytet Medyczny w Szczecinie; Recruiting

Szczecin, Poland, 70-111

Szpital Św. Elżbiety Mokotowskie Centrum Medyczne; Withdrawn

Warszawa, Poland, 02-616

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

Warszawa, Poland, 02-781

Dolnoslaskie Centrum Onkologii; Recruiting

Wrocław, Poland, 53-413

Portugal

Hospitais da universidade de Coimbra; Recruiting

Coimbra, Portugal, 3000-075

Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE; Recruiting

Coimbra, Portugal, 3000-075

Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria; Recruiting

Lisboa, Portugal, 1649-035

Champalimaud Foundation Champalimaud Centre; Recruiting

Lisbon, Portugal, 1400-038

H. Santo António - Centro Hospitalar do Porto; Recruiting

Porto, Portugal, 4099-001

Puerto Rico

VA Caribbean Healthcare System; Recruiting

San Juan, Puerto Rico, 00921

Russian Federation

Altai Regional Oncology Dispensary; Recruiting

Barnaul, Russian Federation, 656045

Ivanovo Regional Oncology Dispensary; Recruiting

Ivanovo, Russian Federation, 153040

Naval Clinical Hospital; Withdrawn

Kaliningrad, Russian Federation, 236029

GUZ Kursk Regional Oncology Dispensary; Recruiting

Kursk, Russian Federation, 305524

Russian Scientific Center of Roentgenoradiology; Recruiting

Moscow, Russian Federation, 117997

Moscow City Clinical Hospital # 62; Recruiting

Moscow, Russian Federation, 125130

Clinical Diagnostic Centre of Nizhny Novgorod Region; Recruiting

Nizhny Novgorod, Russian Federation, 603000

Clinical Oncology Dispensary; Recruiting

Omsk, Russian Federation, 644013

LLC Novaya Clinica; Recruiting

Pyatigorsk, Russian Federation, 357500

Pyatigorsk Regional Oncology Dispensary; Recruiting

Pyatigorsk, Russian Federation, 357502

Private Medical Institution Euromedservice; Recruiting

Saint Petersburg, Russian Federation, 196603

Leningrad Regional Oncology Dispensary; Recruiting

Saint-Petersburg, Russian Federation, 191104

Russian Scientific Center of Radiology and Surgical Technologies; Recruiting

Saint-Petersburg, Russian Federation, 197758

Republican Oncology Dispensary; Recruiting

Saransk, Russian Federation, 430032

Oncologic Dispensary No.2; Recruiting

Sochi, Russian Federation, 354057

Tambov Regional Oncology Clinical Dispansary; Recruiting

Tambov, Russian Federation, 392013

Tomsk Cancer Research Institute; Recruiting

Tomsk, Russian Federation, 634050

Medical-sanitary unit 'Neftyanik'; Recruiting

Tyumen, Russian Federation, 625000

Vologda Regional Oncological Dispensary; Recruiting

Vologda, Russian Federation, 160012

South Africa

Clinresco Centres Pty Ltd; Recruiting

Johannesburg, South Africa, 1619

Clinical Research Unit; Recruiting

Pretoria, South Africa, 0001

East Rand Urology Research Unit; Withdrawn

Vosloorus, South Africa, 1475

Spain

Hosp. Del Mar; Recruiting

Barcelona, Spain, 08003

Hosp. de La Santa Creu I Sant Pau; Recruiting

Barcelona, Spain, 08025

Hosp. Clinic I Provincial de Barcelona; Recruiting

Barcelona, Spain, 08036

Hospital Juan Canalejo; Recruiting

Coruña, Spain, 15006

Hosp. de Jerez de La Frontera; Recruiting

Jerez de la Frontera, Spain, 11407

Hosp. Gral. Univ. Gregorio Marañon; Withdrawn

Madrid, Spain, 28007

Hosp. Univ. Ramon Y Cajal; Recruiting

Madrid, Spain, 28034

Hosp. Clinico San Carlos; Recruiting

Madrid, Spain, 28040

Hosp. Virgen de La Victoria; Recruiting

Málaga, Spain, 29010

Hosp. Quiron Madrid Pozuelo; Recruiting

Pozuelo de Alarcon, Spain, 28223

Corporacio Sanitari Parc Tauli; Recruiting

Sabadell, Spain, 08208

Hosp. Univ. Marques de Valdecilla; Recruiting

Santander, Spain, 39008

Hosp. Univ. I Politecni La Fe; Recruiting

Valencia, Spain, 46026

Sweden

Södersjukhuset; Recruiting

Stockholm, Sweden, 11883

Karolinska Universitetssjukhuset Solna; Recruiting

Stockholm, Sweden, 17176

Akademiska Sjukhuset; Recruiting

Uppsala, Sweden, 751 85

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; Recruiting

Kaohsiung, Taiwan, 807

China Medical University Hospital; Recruiting

Taichung, Taiwan, 403

Taichung Veterans General Hospital; Recruiting

Taichung, Taiwan, 40705

Tungs' Taichung MetroHarbor Hospital; Recruiting

Taichung, Taiwan, 435

Chi Mei Medical Center - Yong Kang; Recruiting

Tainan, Taiwan, 710

National Taiwan University Hospital; Recruiting

Taipei, Taiwan, 100

Taipei Veterans General Hospital; Recruiting

Taipei, Taiwan, 11217

Chang Gung Memorial Hospital; Recruiting

Taoyuan, Taiwan, 33305

Turkey

Adana Baskent Yuregir Hospital; Not yet recruiting

Adana, Turkey, 01250

Cukurova University, Faculty of Medicine; Recruiting

Adana, Turkey, 01330

Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital; Recruiting

Ankara, Turkey, 06200

Ankara Sehir Hastanesi; Recruiting

Ankara, Turkey, 6560

Akdeniz University Medical Faculty; Recruiting

Antalya, Turkey, 07070

Trakya University Medical Faculty; Recruiting

Edirne, Turkey, 22030

Istanbul University Cerrahpasa Medical Faculty; Recruiting

Istanbul, Turkey, 34096

Bakirkoy Training and Research Hospital; Recruiting

Istanbul, Turkey, 34147

Istanbul Medeniyet University Goztepe Training and Research Hospital; Recruiting

Istanbul, Turkey, 34722

Izmir Medical Park Hospital; Recruiting

Izmir, Turkey, 35575

Kocaeli University Medical Faculty; Recruiting

Kocaeli, Turkey, 41380

Ukraine

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

Cherkasy, Ukraine, 18009

Dnipropetrovsk State Medical Academy, Dnipropetrovk State Clinical Hospital NA Mechnikov I.I.; Recruiting

Dnipo, Ukraine, 49005

Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council; Recruiting

Dnipro, Ukraine, 49100

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

Dnipro, Ukraine, 49102

Ivano-Frankivsk Regional Clinical Hospital; Recruiting

Ivano-Frankivsk, Ukraine, 76008

Municipal non-profit enterprise 'Regional Center of Oncology'; Recruiting

Khakhiv, Ukraine, 61070

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

Kharkiv, Ukraine, 61037

State Institution National Cancer Institute; Recruiting

Kyiv, Ukraine, 03022

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

Kyiv, Ukraine, 03115

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

Lviv, Ukraine, 79031

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

Poltava, Ukraine, 36024

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal; Recruiting

Uzhgorod, Ukraine, 88000

Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital; Withdrawn

Zaporizhzhya, Ukraine, 69600

United Kingdom

Aberdeen Royal Infirmary; Withdrawn

Aberdeen, United Kingdom, AB25 2ZB

Royal Blackburn Hospital; Recruiting

Blackburn, United Kingdom, BB2 3HH

Royal Lancaster Infirmary; Recruiting

Lancaster, United Kingdom, LA1 4RP

Royal Marsden Hospital; Withdrawn

London, United Kingdom, SW7 3RP

UCL Cancer Institute; Recruiting

London, United Kingdom, WC1E 6DD

Nottingham University Hospitals NHS Trust; Withdrawn

Nottingham, United Kingdom, NG5 1PB

Torbay Hospital-Devon; Recruiting

Torquay, United Kingdom, TQ2 7AA

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital; Recruiting

Truro, United Kingdom, TR1 3LJ

New Cross Hospital; Recruiting

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

Additional Information:

To learn how to participate in this trial please click here. 

• 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: October 9, 2020
• Last Verified: October 2020

• 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