Clinical Trial - NCT03748641

       

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

Recruiting

Sponsor: Janssen Research & Development, LLC

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03748641

Protocol Info

Short Description: AA-P +/- Niraparib In Prostate Cancer
Long Description: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer
MGH Status: Open
Sponsor: Janssen
Disease Program: GU

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Castration-Resistant Prostatic Cancer Niraparib Abiraterone Acetate Prednisone Placebo New Formulation of Niraparib and Abiraterone Aceta Phase 3
Study Type Interventional
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

Primary Outcome Measures

Cohort 1 and 3: Radiographic Progression Free Survival (rPFS) [Time Frame: Up to 28 months] [Designated as safety issue: ]


Secondary Outcome Measures

Cohort 1: Overall survival (OS) [Time Frame: Up to 66 months] [Designated as safety issue: ]

Cohort 1: Time to Symptomatic Progression [Time Frame: Up to 28 months] [Designated as safety issue: ]

Cohort 1: Time to Initiation of Cytotoxic Chemotherapy [Time Frame: Up to 28 months] [Designated as safety issue: ]

Cohort 1: Observed Plasma Concentrations of Niraparib [Time Frame: Cycle 2 to 7; Each Cycle is of 28 days (Up to 7 months)] [Designated as safety issue: ]

Cohort 1: Observed Trough Plasma Concentrations of Abiraterone [Time Frame: Cycles 2 and 3; Each Cycle is of 28 days (Up to 3 months)] [Designated as safety issue: ]

Cohort 1: Number of Participants with Treatment-Emergent Adverse events (TEAEs) [Time Frame: Up to 66 months] [Designated as safety issue: ]

Cohort 1: Number of Participants with Treatment-Emergent Adverse events by Severity [Time Frame: Up to 66 months] [Designated as safety issue: ]

Cohort 1: Number of Participants with Laboratory Abnormalities as Measure of Safety [Time Frame: Up to 66 months] [Designated as safety issue: ]

Estimated Enrollment: 1000
Study Start Date: January 2019
Estimated Study Completion Date: February 2025
Estimated Primary Completion Date: July 2022
Arms Assigned Interventions

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: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.

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: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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Male

Accepts Healthly 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)

  • • 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT03748641

Locations

  • United States, Alabama
    • Urology Centers Of Alabama Homewood, Alabama, United States, 35209
  • United States, Arizona
    • Mayo Clinic Arizona Phoenix, Arizona, United States, 85054
    • Urological Associates of Southern Arizona, P.C. Tucson, Arizona, United States, 85741
  • United States, Arkansas
    • Arkansas Urology Little Rock, Arkansas, United States, 72211
  • United States, California
    • Kaiser Permanente Riverside, California, United States, 92505
    • San Bernardino Urological Associates San Bernardino, California, United States, 92404
    • University of California San Francisco San Francisco, California, United States, 94158
    • Sansum Clinic Pharm Santa Barbara, California, United States, 93105
    • Kaiser Permanente Medical Center Vallejo, California, United States, 95119
  • United States, Colorado
    • The Urology Center of Colorado Denver, Colorado, United States, 80211
    • Urology Associates of Denver Englewood, Colorado, United States, 80113
    • Foothills Urology - Golden Off Golden, Colorado, United States, 80401-5027
  • 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
    • 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
    • Urology Cancer Center and GU Research Network 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
    • Associated Medical Professionals of Ny Syracuse, New York, United States, 13210
    • 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
    • Centers for Advanced Urology, LLC; d/b/a MidLantic Urology Bala-Cynwyd, Pennsylvania, United States, 19004
    • Lancaster Urology Lancaster, Pennsylvania, United States, 17604
    • VA Pittsburgh Pittsburgh, Pennsylvania, United States, 15240
  • United States, South Carolina
    • Carolina Urologic Research Center Myrtle Beach, South Carolina, United States, 29572
  • United States, Tennessee
    • Urology Associates Nashville, Tennessee, United States, 37209
  • United States, Texas
    • Houston Metro Urology Houston, Texas, United States, 77027
    • University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Utah
    • Utah Cancer Specialists Salt Lake City, Utah, United States, 84106
  • United States, Virginia
    • Salem VA Medical Center Salem, Virginia, United States, 80113
    • Urology of Virginia, PLCC Virginia Beach, Virginia, United States, 23462
  • United States, Washington
    • NorthWest Medical Specialties, PLLC Tacoma, Washington, United States, 98405
  • Argentina,
    • Hospital Aleman Buenos Aires, , Argentina, C1118AAT
    • Hospital Italiano de Buenos Aires C.a.b.a., , Argentina, C1181ACF
    • Fundación CENIT para la Investigación en Neurociencias Capital Federal, , Argentina, CP 1125
    • Centro de Urologia (CDU) Ciudad Automoma Buenos Aires, , Argentina, C1120AAT
    • CEMIC Saavedra Ciudad Autonoma de Buenos Aires, , Argentina, C1431FWN
    • 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, , Argentina, B7600FZN
    • Hospital Privado de Comunidad Mar Del Plata, , Argentina, B7602CBM
    • Centro de Investigacion Pergamino SA Pergamino, , Argentina, B2700CPM
    • Sanatorio Britanico de Rosario Rosario, , Argentina, 2000
    • Sanatorio Parque Rosario, , Argentina, S2000SDV
    • ARS Médica San Salvador De Jujuy, , Argentina, Y4600AFW
  • Australia,
    • Royal Adelaide Hospital Adelaide, , Australia, 5116
    • Pindara Private Hospital Benowa, , Australia, 4217
    • Sunshine Coast University Hospital Birtinya, , Australia, 4575
    • Princess Alexandra Hospital Brisbane, , Australia, 4102
    • Chris O'Brien Lifehouse Camperdown, , Australia, 2050
    • St. Vincent's Hospital Sydney Darlinghurst, , Australia, 2010
    • Royal Hobart Hospital Hobart, , Australia, 7000
    • Macquarie University Macquarie University, , Australia, 2109
    • Cabrini Health Malvern, , Australia, 3144
    • Peter MacCallum Cancer Centre Melbourne, , Australia, 3000
    • Fiona Stanley Hospital Murdoch, , Australia, 6150
    • Hollywood Private Hospital Nedlands, , Australia, 6009
    • Prince Of Wales Hospital Randwick, , Australia, 2031
    • Sydney Adventist Hospital Wahroonga, , Australia, 2076
    • Wollongong Private Hospital Wollongong, , Australia, 2500
  • Belgium,
    • OLV Ziekenhuis Aalst Aalst, , Belgium, 9300
    • ZNA Middelheim Antwerpen, , Belgium, 2020
    • Grand Hôpital de Charleroi, site Notre Dame Charleroi, , Belgium, 6000
    • AZ Maria Middelares Gent, , Belgium, 9000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman Liege, , Belgium, B-4000
    • ZNA Jan Palfijn Merksem, , Belgium, 2170
  • Brazil,
    • Hospital Do Cancer De Barretos - Fundacao Pio Xii Barretos, , Brazil, 14784-400
    • PERSONAL - Oncologia de Precisão e Personalizada Belo Horizonte, , Brazil, 30130-090
    • Hospital Sírio Libanes Unidade Brasilia Brasilia, , Brazil, 70200-730
    • CIONC - Centro Integrado de Oncologia de Curitiba Curitiba, , Brazil, 80810-050
    • Pronutrir Fortaleza, , Brazil, 60 810180
    • Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Goiânia, , Brazil, 74605-070
    • Hospital de Caridade de Ijui - CACON Ijui, , Brazil, 98700-000
    • Fundação São Francisco Xavier Ipatinga, , Brazil, 35162 189
    • Clínica de Neoplasias Litoral Ltda. Itajai, , Brazil, 88301-220
    • 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, 59075-740
    • Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, , Brazil, 90020-090
    • Hospital Ernesto Dornelles Porto Alegre, , Brazil, 90160-093
    • Instituto Nacional do Cancer - INCA Rio de Janeiro, , Brazil, 20230-130
    • Hospital Universitário Pedro Ernesto Rio de Janeiro, , Brazil, 20551-030
    • Oncoclínicas Rio De Janeiro, , Brazil, 22250-905
    • Instituto COI de Pesquisa, Educacao e Gestao Rio de Janeiro, , Brazil, 22793-080
    • Hospital Santa Isabel Salvador, , Brazil, 40050-410
    • CEPHO - Faculdade de Medicina do ABC Santo André, , Brazil, 09060-870
    • Santa Casa de Misericordia de São Paulo Sao Paulo, , Brazil, 01221-020
    • Instituto de Ensino E Pesquisa Sao Lucas Sao Paulo, , Brazil, 01236-030
    • ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA Sao Paulo, , Brazil, 01246-000
    • Hospital Alemão Oswaldo Cruz Sao Paulo, , Brazil, 01421-000
    • Fundacao Antonio Prudente Sao Paulo, , Brazil, 01509900
    • IBCC Instituto Brasileiro de Controle do Cancer Sao Paulo, , Brazil, 03102-002
    • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado Sorocaba, , Brazil, 18030-005
    • Hospital Samaritano de São Paulo São Paulo, , Brazil, 01243-020
    • 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
    • Instituto do Cancer De Tres Lagoas Três Lagoas, , Brazil, 79603110
  • Bulgaria,
    • MHAT Deva Maria Burgas, , Bulgaria, 8001
    • UMHAT 'Dr. Georgi Stranski', EAD Pleven, , Bulgaria, 5800
    • Complex Oncology Center - Plovdiv EOOD Plovdiv, , Bulgaria, 4004
    • Specialized Hospital for Active Treatment in Oncology EAD Sofia, , Bulgaria, 1756
    • SHATOD 'Dr. Marko Antonov Markov' Varna, , Bulgaria, 9010
    • Comprehensive Cancer Center Vratsa, , Bulgaria, 3001
  • Canada, Alberta
    • Southern Alberta Institute of Urology / Prostate Cancer Centre Calgary, Alberta, Canada, T2V 1P9
  • Canada, British Columbia
    • British Columbia Cancer Agency (BCCA) - Vancouver Centre Vancouver, British Columbia, Canada, V5Z 4E6
    • British Columbia Cancer Agency - Vancouver Island Centre Victoria, British Columbia, Canada, V8R 6V5
  • Canada, Ontario
    • McMaster Institute of Urology Hamilton, Ontario, Canada, L8N 4A6
    • Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre) Kingston, Ontario, Canada, K7L 3N6
    • Sunnybrook Health Sciences Center Toronto, Ontario, Canada, M4N 3M5
    • University Health Network (UHN) Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • Centre de Recherche du CHUM Montreal, Quebec, Canada, H2X 0A9
  • Canada, Saskatchewan
    • Saskatoon Cancer Centre Saskatoon, Saskatchewan, Canada, S7N 4H4
  • China,
    • Cancer Hospital Chinese Academy of Medical Sciences Beijing, , China, 100021
    • Peking University First Hospital Beijing, , China, 100034
    • Beijing Friendship Hospital Beijing, , China, 100050
    • Beijing Cancer Hospital of Peking University Beijing, , China, 100142
    • Peking University Third Hospital Beijing, , China, 100191
    • Beijing Hospital BeiJing, , China, 100730
    • Sichuan Provincial People's Hospital Chengdu, , China, 610072
    • Southwest Hospital, The Third Military Medical University Chongqing, , China, 400025
    • Chongqing 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
    • The First Affiliated hospital of Anliui Medical University Hefei, , China,
    • 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
    • Shanghai Zhongshan Hospital 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
    • First Affiliated Hospital, Xi'an Jiaotong University Xi'an, , China, 710061
  • Czechia,
    • Komplexni onkologicke centrum Multiscan s.r.o. Horovice, , Czechia, 26831
    • Fakultni nemocnice Hradec Kralove Hradec Králove, , Czechia, 500 05
    • Krajská nemocnice Liberec Liberec, , Czechia, 460 63
    • Uromedical Center s.r.o. Olomouc, , Czechia, 77900
    • Multiscan s.r.o. Pardubice, , Czechia, 53203
    • Fakultni nemocnice Plzen, Urologicka klinika Plzen, , Czechia, 305 99
    • Urologicka klinika 1.LF UK a VFN Praha 2, , Czechia, 120 00
    • Thomayerova nemocnice, Onkologicka klinika Praha 4, , Czechia, 140 59
    • Uherskohradistska nemocnice a.s. Uherske Hradiste, , Czechia, 68668
  • France,
    • CHRU De Besancon Besancon, , France, 25030
    • Institut Bergonié Bordeaux, , France, 33000
    • Centre Jean Perrin Clermont Ferrand, , France, 63011
    • Centre Leon Bérard Lyon, , France, 69008
    • Institut Regional du Cancer de Montpellier Val d'Aurelle Montpellier, , France, 34298
    • Polyclinique de Gentilly Nancy, , France, 54100
    • Centre Antoine Lacassagne Nice Cedex 2, , France, 06189
    • Hopital Europeen Georges-Pompidou Paris Cedex 15, , France, 75908
    • Institut de Cancérologie de l'Ouest (ICO) Saint Herblain, , France, 44805
    • HIA Begin Saint Mande, , France, 94163
    • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Strasbourg Cedex, , France, 67098
  • Germany,
    • Charite - Universitatsmedizin Berlin (CCM) Berlin, , Germany, 12200
    • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer Braunschweig, , Germany, 38126
    • Urologicum Duisburg Duisburg, , Germany, 47179
    • Universitatsklinikum Essen Essen, , Germany, 45147
    • Universitätsklinikum des Saarlandes Homburg, , Germany, 66424
    • Klinik und Poliklinik für Urologie Köln, , Germany, 50937
    • Universitätsklinikum Otto-von-Guericke-Universität Magdeburg Magdeburg, , Germany, 39120
    • Universitaetsklinikum Muenster Muenster, , Germany, 48149
    • Studienpraxis Urologie Drs. Feyerabend Nuertingen, , Germany, 72622
  • Hungary,
    • Semmelweis Egyetem, Urológia Klinika Budapest, , Hungary, 1082
    • Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály Budapest, , Hungary, 1122
    • Szent János Kórház és Észak-budai Egyesített Kórházak Budapest, , Hungary, 1125
    • Debreceni Egyetem Klinikai Kozpont Debrecen, , Hungary, 4032
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Gyula, , Hungary, 5700
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Nyiregyhaza, , Hungary, 4400
    • Uro-Clin Kft. Pécs, , Hungary, 7621
    • Szegedi Tudomanyegyetem Szeged, , Hungary, 6720
    • Szegedi Tudomanyegyetem Szeged, , Hungary, 6725
    • Markusovszky Egyetemi Oktatokorhaz Szombathely, , Hungary, 9700
  • Israel,
    • Asaf Harofe Medical Center Beer Yaakov, , Israel, 60930
    • Rambam Health Care Campus Haifa, , Israel, 31096
    • Rabin Medical Center Petah Tikva, , Israel, 49100
    • Sheba Medical Center Tel Hashomer Ramat Gan, , Israel, 52621
  • Italy,
    • AUSL Romagna - Ospedale di Faenza Faenza, , Italy, 48018
    • Ospedale San Raffaele Milano, , Italy, 20132
    • ASST Grande Ospedale Metropolitano Niguarda Milano, , Italy, 20162
    • Oncologia Medica A - Ist Naz Tumori G Pascale Napoli, , Italy, 80131
    • Istituto Oncologico Veneto Iov Irccs Padova Padova, , Italy, 35128
    • Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma Parma, , Italy, 43126
    • Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica Perugia, , Italy, 06132
    • Azienda Ospedaliero Universitaria Pisana Pisa, , Italy, 56126
    • Fondazione Policlinico Universitario A. Gemelli IRCCS Roma, , Italy, 00168
    • Campus Bio-Medico di Roma Roma, , Italy, 128
    • Azienda Ospedaliera S. Maria Terni Terni, , Italy, 5100
    • A.O.U. Città della Salute e della Scienza Torino, , Italy, 10126
    • Ospedale Santa Chiara Trento Trento, , Italy, 38122
  • Korea, Republic of,
    • Pusan National University Hospital. Busan, , Korea, Republic of, 49241
    • Kyungpook National University Chilgok Hospital Daegu, , Korea, Republic of, 41404
    • Keimyung University Dongsan Hospital Daegu, , Korea, Republic of, 42601
    • Chungnam National University Hospital Daejeon, , Korea, Republic of, 35015
    • National Cancer Center Goyang-Si, , Korea, Republic of, 10408
    • Chonnam National University Hospital Gwangju, , Korea, Republic of, 61469
    • Seoul National University Bundang Hospital Seongnam-si, , Korea, Republic of, 13620
    • Seoul National University Hospital Seoul, , Korea, Republic of, 03080
    • Severance Hospital Seoul, , Korea, Republic of, 03722
    • Gangnam Severance Hospital Seoul, , Korea, Republic of, 06273
    • Samsung Medical Center Seoul, , Korea, Republic of, 06351
    • Seoul St. Mary's Hospital Seoul, , Korea, Republic of, 06591
    • Asan Medical Center Seoul, , Korea, Republic of, 5505
    • Ajou University Hospital Suwon, , Korea, Republic of, 443-721
  • Malaysia,
    • Hospital Pulau Pinang George Town, , Malaysia, 10990
    • Hospital Sultan Ismail Johor Bahru, , Malaysia, 81100
    • Hospital Likas Kota Kinabalu, , Malaysia, 88996
    • Hospital Kuala Lumpur Kuala Lumpur, , Malaysia, 50586
    • University Malaya Medical Centre Kuala Lumpur, , Malaysia, 59100
    • Sarawak General Hospital Kuching, , Malaysia, 93586
  • Mexico,
    • iBiomed Research Unit Aguascalientes, , Mexico, 20010
    • Mexico Centre for Clinical Research, S.A. de C.V. Ciudad de Mexico, , Mexico, 03100
    • Consultorio de Especialidad en Urologia Privado Durango, , Mexico, 34000
    • Centro Medico Nacional Siglo XXI IMSS Mexico, , Mexico, 06720
    • Avix Investigacion Clinica, S.C. Monterrey, , Mexico, 64710
    • Consultorio Privado Zapopan, , Mexico, 45040
  • Netherlands,
    • NKI-AVL, Amsterdam Amsterdam, , Netherlands, 1066 CX
    • Universitair Medisch Centrum Groningen Groningen, , Netherlands, 9713 GZ
    • MC Haaglanden Lok Antoniushove - Afd.Interne - INT Leidschendam, , Netherlands, 2262 BA
    • St. Antonius Ziekenhuis (St. Antonius Hospital) Nieuwegein, , Netherlands, 3430EM
    • Canisius-Wilhelminaziekenhuis Nijmegen, , Netherlands, 6532 SZ
    • Erasmus MC Rotterdam, , Netherlands, 3075 EA
    • Zuyderland Medical Center Sittard-Geleen, , Netherlands, 6162 BG
  • Poland,
    • Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza Bydgoszcz, , Poland, 85-094
    • Centrum Onkologii im. Prof. F. Lukaszczyka Bydgoszcz, , Poland, 85-796
    • Uniwersyteckie Centrum Kliniczne Gdansk, , 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
    • Wielkopolskie Centrum Onkologii Poznan, , Poland, 61-866
    • Urologica Praktyka Lekarska Adam Marcheluk Siedlce, , Poland, 08-110
    • Pomorski Uniwersytet Medyczny w Szczecinie Szczecin, , Poland, 70-111
    • Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne Warszawa, , Poland, 02-616
    • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa, , Poland, 02-781
    • Dolnoslaskie Centrum Onkologii Wroclaw, , Poland, 53-413
  • Portugal,
    • Hospitais da universidade de Coimbra Coimbra, , Portugal, 3000-075
    • Instituto Português 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
    • Naval Clinical Hospital Kaliningrad, , Russian Federation, 236029
    • 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 Saint-Petersburg, , 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
    • East Rand Urology Research Unit Vosloorus, , South Africa, 1475
  • Spain,
    • Hosp. Del Mar Barcelona, , Spain, 08003
    • Hosp. de La Santa Creu I Sant Pau Barcelona, , Spain, 08025
    • Hosp. Clinic I Provincial de Barcelona Barcelona, , Spain, 08036
    • Hospital Juan Canalejo Coruña, , Spain, 15006
    • Hosp. de Jerez de La Frontera Jerez de la Frontera, , Spain, 11407
    • Hosp. Gral. Univ. Gregorio Marañon Madrid, , Spain, 28007
    • Hosp. Univ. Ramon Y Cajal Madrid, , Spain, 28034
    • Hosp. Clinico San Carlos Madrid, , Spain, 28040
    • Hosp. Virgen de La Victoria Málaga, , Spain, 29010
    • Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcon, , Spain, 28223
    • Corporacio Sanitari Parc Tauli Sabadell, , Spain, 08208
    • Hosp. Univ. Marques de Valdecilla Santander, , Spain, 39008
    • Hosp. Univ. I Politecni La Fe Valencia, , Spain, 46026
  • Sweden,
    • Södersjukhuset Stockholm, , Sweden, 11883
    • Karolinska Universitetssjukhuset Solna Stockholm, , Sweden, 17176
    • Akademiska Sjukhuset Uppsala, , Sweden, 751 85
  • Taiwan,
    • Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung, , Taiwan, 807
    • China Medical University Hospital Taichung, , Taiwan, 403
    • Taichung Veterans General Hospital Taichung, , Taiwan, 40705
    • Tungs' Taichung MetroHarbor Hospital Taichung, , Taiwan, 435
    • Chi Mei Medical Center - Yong Kang Tainan, , Taiwan, 710
    • National Taiwan University Hospital Taipei, , Taiwan, 100
    • Taipei Veterans General Hospital Taipei, , Taiwan, 11217
    • Chang Gung Memorial Hospital Taoyuan, , Taiwan, 33305
  • Turkey,
    • Adana Baskent Yuregir Hospital Adana, , Turkey, 01250
    • 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
    • Istanbul Medeniyet University Goztepe Training and Research Hospital Istanbul, , Turkey, 34722
    • Izmir Medical Park Hospital Izmir, , Turkey, 35575
    • Kocaeli University Medical Faculty Kocaeli, , Turkey, 41380
  • Ukraine,
    • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' Cherkasy, , Ukraine, 18009
    • Dnipropetrovsk State Medical Academy, Dnipropetrovk State Clinical Hospital NA Mechnikov I.I. 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, 79031
    • 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
    • Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital Zaporizhzhya, , Ukraine, 69600
  • United Kingdom,
    • Aberdeen Royal Infirmary Aberdeen, , United Kingdom, AB25 2ZB
    • Royal Blackburn Hospital Blackburn, , United Kingdom, BB2 3HH
    • Royal Lancaster Infirmary Lancaster, , United Kingdom, LA1 4RP
    • Royal Marsden Hospital London, , United Kingdom, SW7 3RP
    • UCL Cancer Institute London, , United Kingdom, WC1E 6DD
    • Nottingham University Hospitals NHS Trust Nottingham, , United Kingdom, NG5 1PB
    • 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

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03748641
Other Study ID Numbers: 2017-003364-12
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Prednisone

Abiraterone Acetate

Niraparib

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on January 20, 2021