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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)

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ClinicalTrials.gov Identifier: NCT03748641
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : October 31, 2019
Sponsor:
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 and prednisone (AA-P) compared to AA-P plus placebo.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: Niraparib Drug: Abiraterone Acetate Drug: Prednisone Drug: Placebo Phase 3

Detailed Description:
This study will assess efficacy and safety of niraparib in combination with AA-P for the treatment of participants with metastatic 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 17α-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 gene defects (DRD) 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 double-blind treatment phase, and a follow up phase. During the prescreening phase participants will be evaluated for DRD 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 up to 73 months.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Niraparib + Abiraterone Acetate-Prednisone (AA-P)
Participants will receive oral administration of niraparib 200 milligram (mg) (2 capsules of 100 mg each) in combination with abiraterone acetate (AA) 1000 mg (4 tablets of 250 mg each) tablets and prednisone 10 mg (2 tablets of 5 mg each) tablets daily in each cycle (each cycle of 28 days).
Drug: Niraparib
Participants will receive niraparib 200 mg (2 capsules of 100 mg each) capsules once daily.
Other Name: JNJ-64091742

Drug: Abiraterone Acetate
Participants will receive abiraterone acetate 1000 mg (4 tablets of 250 mg each) tablets once daily.

Drug: Prednisone
Participants will receive prednisone 10 mg (2 tablets of 5 mg each) tablets daily.

Active Comparator: Placebo + AA-P
Participants will receive oral administration of matching placebo capsules in combination with AA 1000 mg (4 tablets of 250 mg each) tablets and prednisone 10 mg (2 tablets of 5 mg each) tablets daily in each cycle (each cycle of 28 days).
Drug: Abiraterone Acetate
Participants will receive abiraterone acetate 1000 mg (4 tablets of 250 mg each) tablets once daily.

Drug: Prednisone
Participants will receive prednisone 10 mg (2 tablets of 5 mg each) tablets daily.

Drug: Placebo
Participants will receive matching placebo capsules once daily.




Primary Outcome Measures :
  1. Radiographic Progression Free Survival (rPFS) [ Time Frame: Approximately 40 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. Bone progression is defined as one of the following: participants whose confirmatory scan shows >=2 new lesions will be considered to have bone scan progression and who 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. Overall survival (OS) [ Time Frame: Approximately up to 73 months ]
    OS is defined as the time from date of randomization to date of death from any cause.

  2. Time to Symptomatic Progression [ Time Frame: Up to 40 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. Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: Up to 40 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. 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. 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. Number of Participants with Treatment-Emergent Adverse events (TEAEs) [ Time Frame: Approximately up to 73 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. Number of Participants with Treatment-Emergent Adverse events by Severity [ Time Frame: Approximately up to 73 months ]
    An adverse event 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. 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 5) Death

  8. Number of Participants with Laboratory Abnormalities as Measure of Safety [ Time Frame: Approximately up to 73 months ]
    Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Deoxyribonucleic acid (DNA)-repair gene defects (DRD) status (as identified by the sponsor's required assays) as follows:

    1. Cohort 1: positive for DRD
    2. Cohort 2: not positive for DRD (i.e. No DRD)
  • 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 [AA-P] prior to randomization) in the metastatic castration-sensitive prostate cancer (mCRPC) setting; or AA-P 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 ClinicalTrials.gov identifier (NCT number): NCT03748641


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

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Locations
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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, California
Kaiser Permanente Not yet recruiting
Riverside, California, United States, 92505
San Bernardino Urological Associates Recruiting
San Bernardino, California, United States, 92404
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94158
Kaiser Permanente Medical Center Withdrawn
Vallejo, California, United States, 95119
United States, Colorado
The Urology Center of Colorado Not yet 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 Not yet recruiting
Jacksonville, Florida, United States, 32209
United States, Illinois
Veterans Affairs Medical Ctr Not yet recruiting
Hines, Illinois, United States, 60141
United States, Kansas
University of Kansas Medical Center Withdrawn
Kansas City, Kansas, United States, 66160
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
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, Missouri
Kansas City Veterans Affairs Medical Center Not yet recruiting
Kansas City, Missouri, United States, 64128
United States, Nebraska
Adult Pediatric Urology & Urogynecology, P.C Recruiting
Omaha, Nebraska, United States, 68114
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
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg Not yet recruiting
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Upstate Cancer Center Not yet recruiting
Syracuse, New York, United States, 13210
United States, Pennsylvania
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, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists Not yet 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) Recruiting
Ciudad Automoma Buenos Aires, Argentina, C1120AAT
CEMIC Saavedra Recruiting
Ciudad Autonoma 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 Not yet 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
Brazil
Hospital Do Cancer De Barretos - Fundacao Pio Xii Not yet recruiting
Barretos, Brazil, 14784-400
PERSONAL - Oncologia de Precisão e Personalizada Not yet recruiting
Belo Horizonte, Brazil, 30130-090
Hospital Sírio Libanes Unidade Brasilia Not yet recruiting
Brasilia, Brazil, 70200-730
CIONC - Centro Integrado de Oncologia de Curitiba Not yet recruiting
Curitiba, Brazil, 80810-050
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Not yet recruiting
Goiânia, Brazil, 74605-070
Hospital de Caridade de Ijui - CACON Not yet recruiting
Ijui, Brazil, 98700-000
Clínica de Neoplasias Litoral Ltda. Not yet recruiting
Itajai, Brazil, 88301-220
Instituto Joinvilense De Hematologia e Oncologia Not yet recruiting
Joinville, Brazil, 89201260
Centro de Tratamento de câncer Medradius Not yet recruiting
Maceió, Brazil, 57052-765
Liga Norte Riograndense Contra O Cancer Not yet recruiting
Natal, Brazil, 59075-740
Irmandade Santa Casa de Misericordia de Porto Alegre Not yet recruiting
Porto Alegre, Brazil, 90020-090
Instituto Nacional do Cancer - INCA Not yet recruiting
Rio de Janeiro, Brazil, 20230-130
Hospital Universitário Pedro Ernesto Not yet recruiting
Rio de Janeiro, Brazil, 20551-030
Instituto COI de Pesquisa, Educacao e Gestao Not yet recruiting
Rio de Janeiro, Brazil, 22793-080
Hospital Santa Isabel Not yet recruiting
Salvador, Brazil, 40050-410
CEPHO - Faculdade de Medicina do ABC Not yet recruiting
Santo André, Brazil, 09060-870
Santa Casa de Misericordia de São Paulo Not yet recruiting
Sao Paulo, Brazil, 01221-020
Instituto de Ensino E Pesquisa Sao Lucas Not yet recruiting
Sao Paulo, Brazil, 01236-030
ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA Not yet recruiting
Sao Paulo, Brazil, 01246-000
Fundacao Antonio Prudente Not yet recruiting
Sao Paulo, Brazil, 01509900
IBCC Instituto Brasileiro de Controle do Cancer Not yet recruiting
Sao Paulo, Brazil, 03102-002
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado Not yet recruiting
Sorocaba, Brazil, 18030-005
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO Not yet recruiting
São Paulo, Brazil, 04039-004
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 Not yet recruiting
Burgas, Bulgaria, 8001
UMHAT 'Dr. Georgi Stranski', EAD Not yet recruiting
Pleven, Bulgaria, 5800
Complex Oncology Center - Plovdiv EOOD Not yet recruiting
Plovdiv, Bulgaria, 4004
Specialized Hospital for Active Treatment in Oncology EAD Not yet recruiting
Sofia, Bulgaria, 1756
SHATOD 'Dr. Marko Antonov Markov' Not yet recruiting
Varna, Bulgaria, 9010
Comprehensive Cancer Center Not yet 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 Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
China
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, China, 100021
Peking University First Hospital Not yet recruiting
Beijing, China, 100034
Beijing Friendship Hospital Not yet recruiting
Beijing, China, 100050
Beijing Cancer Hospital of Peking University Not yet recruiting
Beijing, China, 100142
Peking University Third Hospital Not yet recruiting
Beijing, China, 100191
Beijing Hospital Not yet 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 Not yet 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 Not yet 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 Not yet recruiting
Shanghai, China, 200032
Shanghai Zhongshan Hospital Not yet recruiting
ShangHai, China, 200032
Huashan Hospital Fudan University Not yet recruiting
Shanghai, China, 200040
ShangHai Huadong Hospital Not yet 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 Not yet recruiting
Suzhou, China, 215006
Tianjin Medical University Cancer Hospital Not yet recruiting
Tianjin, China, 300060
The Central Hospital of Wuhan Not yet recruiting
Wuhan, China, 430014
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Not yet recruiting
Wuhan, China, 430030
Wuxi People's Hospital Not yet recruiting
Wuxi, China, 214023
First Affiliated Hospital, Xi'an Jiaotong University Not yet recruiting
Xi'an, China, 710061
Czechia
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
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 Not yet recruiting
Montpellier, France, 34298
Polyclinique de Gentilly Recruiting
Nancy, France, 54100
Centre Antoine Lacassagne Recruiting
Nice Cedex 2, France, 06189
Hopital Europeen Georges-Pompidou Not yet 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 Universitaire de Strasbourg -CHU Recruiting
Strasbourg, France, 67091
Germany
Charite - Universitatsmedizin Berlin (CCM) Not yet recruiting
Berlin, Germany, 12200
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer Recruiting
Braunschweig, Germany, 38126
Urologicum Duisburg Recruiting
Duisburg, Germany, 47179
Universitätsklinikum des Saarlandes Not yet recruiting
Homburg, Germany, 66424
Klinik und Poliklinik für Urologie Not yet recruiting
Köln, Germany, 50937
Universitätsklinikum Otto-von-Guericke-Universität Magdeburg Not yet recruiting
Magdeburg, Germany, 39120
Universitaetsklinikum Muenster Not yet 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 Not yet recruiting
Nyiregyhaza, Hungary, 4400
Uro-Clin Kft. Completed
Pécs, Hungary, 7621
Szegedi Tudomanyegyetem Recruiting
Szeged, Hungary, 6725
Markusovszky Egyetemi Oktatokorhaz Not yet 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 Not yet 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 Not yet 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
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
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
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, 53000
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. Not yet recruiting
Ciudad de Mexico, Mexico, 03100
Consultorio de Especialidad en Urologia Privado Recruiting
Durango, Mexico, 34000
Centro Medico Nacional Siglo XXI IMSS Not yet recruiting
Mexico, Mexico, 06720
Avix Investigacion Clinica, S.C. Not yet recruiting
Monterrey, Mexico, 64710
Consultorio Privado Not yet recruiting
Zapopan, Mexico, 45040
Netherlands
NKI-AVL, Amsterdam Recruiting
Amsterdam, Netherlands, 1066 CX
Universitair Medisch Centrum Groningen Not yet 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 Not yet recruiting
Szczecin, Poland, 70-111
Szpital Św. Elżbiety Mokotowskie Centrum Medyczne Withdrawn
Warszawa, Poland, 02-616
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Recruiting
Warszawa, Poland, 02‐781
Dolnoslaskie Centrum Onkologii Recruiting
Wrocław, Poland, 53-413
Portugal
Hospitais da universidade de Coimbra Not yet recruiting
Coimbra, Portugal, 3000-075
Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE Not yet recruiting
Coimbra, Portugal, 3000-075
Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria Not yet recruiting
Lisboa, Portugal, 1649-035
Champalimaud Foundation Champalimaud Centre Not yet recruiting
Lisbon, Portugal, 1400-038
H. Santo António - Centro Hospitalar do Porto Not yet recruiting
Porto, Portugal, 4099-001
Puerto Rico
VA Caribbean Healthcare System Not yet 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 Not yet recruiting
Kaliningrad, Russian Federation, 236029
State Health Establishment Kursk Regional Oncology Dispensary Not yet recruiting
Kursk, Russian Federation, 305035
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 Not yet recruiting
Saint-Petersburg, Russian Federation, 191104
Russian Scientific Center of Radiology and Surgical Technologies Not yet recruiting
Saint-Petersburg, Russian Federation, 197758
Republican Oncology Dispensary Not yet 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 Not yet 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 Maranon Not yet recruiting
Madrid, Spain, 28007
Hosp. Univ. Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Hosp. Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hosp. Virgen de La Victoria Not yet 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 Not yet recruiting
Stockholm, Sweden, 11861
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
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
Izmır 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' Recruiting
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 Not yet recruiting
Zaporizhzhya, Ukraine, 69600
United Kingdom
Royal Blackburn Hospital Recruiting
Blackburn, United Kingdom, BB2 3HH
Royal Lancaster Infirmary Recruiting
Lancaster, United Kingdom, LA1 4RP
UCL Cancer Institute Recruiting
London, United Kingdom, WC1E 6DD
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
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03748641     History of Changes
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: October 31, 2019
Last Verified: October 2019

Layout table for additional information
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
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
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