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Trial record 1 of 1 for:    NCT03748641
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03748641
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : August 3, 2022
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

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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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03748641

Hide Hide 318 study locations
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Nijmegen, Netherlands, 6532 SZ
Erasmus MC
Rotterdam, Netherlands, 3075 EA
Zuyderland Medical Center
Sittard-Geleen, Netherlands, 6162 BG
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
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
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
Stockholm, Sweden, 11883
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 171 76
Akademiska Sjukhuset
Uppsala, Sweden, 751 85
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
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
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
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT03748641    
Other Study ID Numbers: CR108534
2017-003364-12 ( EudraCT Number )
64091742PCR3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Abiraterone Acetate
Anti-Inflammatory Agents
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