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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Castration-Resistant Prostatic Cancer
• Intervention / Treatment: Drug: Niraparib; Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Placebo; Drug: New Formulation of Niraparib and Abiraterone Acetate (AA)

Detailed Description

This study will assess efficacy and safety of niraparib in combination with AAP for the treatment of participants with metastatic castration resistant prostate cancer. Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone and selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), which is found in the testes and adrenals, as well as in prostate tissues and tumors. In participants with metastatic prostate cancer, DNA-repair anomalies are identified in approximately 15 percent (%) to 20% of tumors. The study will consist of 5 phases: a prescreening phase for biomarker evaluation only, a screening phase, a treatment phase, a follow up phase, and an extension phase (either open-label extension [OLE] or long-term extension [LTE]). During the prescreening phase participants will be evaluated for homologous recombination repair (HRR) gene alteration status and then will be assigned to one of the 2 cohorts based on their biomarker status. Treatment will be administered daily and is planned to be continuous until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy, pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 66 months.

• Study Type: Interventional
• Enrollment (Actual): 765
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman
  • Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben
  • Ciudad Automoma Buenos Aires, Argentina, C1120AAT
    • Centro de Urologia (CDU)
  • Ciudad Autonoma de Buenos Aires, Argentina, C1431FWN
    • CEMIC Saavedra
  • Cordoba, Argentina, X5016KEH
    • Hospital Privado - Centro Medico de Cordoba
  • Cordoba, Argentina, 5000
    • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Mar Del Plata, Argentina, B7602CBM
    • Hospital Privado de Comunidad
  • Mar Del Plata, Buenos Aires, Argentina, B7600FZN
    • Instituto de Investigaciones Clinicas Mar del Plata
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigacion Pergamino SA
  • Rosario, Argentina, 2000
    • Sanatorio Británico de Rosario
  • Rosario, Argentina, S2000SDV
    • Sanatorio Parque
  • San Salvador De Jujuy, Argentina, Y4600AFW
    • ARS Medica
• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Benowa, Australia, 4217
    • Pindara Private Hospital
  • Birtinya, Australia, 4575
    • Sunshine Coast University Hospital
  • Brisbane, Australia, 4102
    • Princess Alexandra Hospital
  • Darlinghurst, Australia, 2010
    • St. Vincent's Hospital Sydney
  • Hobart, Australia, 7000
    • Royal Hobart Hospital
  • Macquarie University, Australia, 2109
    • Macquarie University
  • Malvern, Australia, 3144
    • Eye Surgery Associates
  • Melbourne, Australia, 3000
    • Peter Maccallum Cancer Centre
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • Nedlands, Australia, 6009
    • Hollywood Private Hospital
  • Randwick, Australia, 2031
    • Prince of Wales Hospital
  • Wahroonga, Australia, 2076
    • Sydney Adventist Hospital
  • Wollongong, Australia, 2500
    • Wollongong Private Hospital
• Belgium
  • Aalst, Belgium, 9300
    • OLV Ziekenhuis Aalst
  • Antwerpen, Belgium, 2020
    • ZNA Middelheim
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi, site Notre Dame
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Liege, Belgium, B-4000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Merksem, Belgium, 2170
    • ZNA Jan Palfijn
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII
  • Belo Horizonte, Brazil, 30130-090
    • Personal Oncologia de Precisao e Personalizada
  • Brasilia, Brazil, 7020-730
    • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
  • Curitiba, Brazil, 80810 050
    • CIONC Centro Integrado de Oncologia de Curitiba
  • Fortaleza, Brazil, 60 810180
    • Pronutrir
  • Goiania, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Ijui, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Ipatinga, Brazil, 35162 189
    • Fundação São Francisco Xavier
  • Joinville, Brazil, 89201-260
    • Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
  • Maceio, Brazil, 57052-765
    • Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
  • Natal, Brazil, 59062 000
    • Liga Norte Riograndense Contra O Câncer
  • Porto Alegre, Brazil, 90020-090
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90160-093
    • Hospital Ernesto Dornelles
  • Rio de Janeiro, Brazil, 20230-130
    • Ministerio da Saude - Instituto Nacional do Cancer
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Rio de Janeiro, Brazil, 20551-030
    • Universidade do Estado do Rio de Janeiro - UERJ
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Salvador, Brazil, 40050-410
    • Hospital Santa Isabel
  • Santo Andre, Brazil, 09060-870
    • Fundacao do ABC - Centro Universitario FMABC
  • Sao Paulo, Brazil, 01246-000
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • Sao Paulo, Brazil, 01236-030
    • Instituto de Ensino E Pesquisa Sao Lucas
  • Sao Paulo, Brazil, 01221-020
    • Irmandade Santa Casa de Misericordia de Sao Paulo
  • Sao Paulo, Brazil, 01421-000
    • Hospital Alemao Oswaldo Cruz
  • Sao Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • Sao Paulo, Brazil, 04039-004
    • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  • Sorocaba, Brazil, 18030-005
    • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
  • São Paulo, Brazil, 04014-002
    • Núcleo de Pesquisa São Camilo
  • São Paulo, Brazil, 04502-001
    • Instituto D Or de Pesquisa e Ensino (IDOR)
  • Tres Lagoas, Brazil, 79601-001
    • Instituto do Cancer De Tres Lagoas
• Bulgaria
  • Burgas, Bulgaria, 8001
    • MHAT Deva Maria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center - Plovdiv EOOD
  • Sofia, Bulgaria, 1756
    • Specialized Hospital for Active Treatment in Oncology EAD
  • Varna, Bulgaria, 9010
    • SHATOD 'Dr. Marko Antonov Markov'
  • Vratsa, Bulgaria, 3001
    • Comprehensive Cancer Center
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Southern Alberta Institute of Urology / Prostate Cancer Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency (BCCA) - Vancouver Centre
    • Victoria, British Columbia, Canada, V8R 6V5
      • British Columbia Cancer Agency - Vancouver Island Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • McMaster Institute of Urology
    • Kingston, Ontario, Canada, K7L 3N6
      • Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Center
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network (UHN) Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre de Recherche du CHUM
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• China
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China, 100142
    • Beijing Cancer Hospital of Peking University
  • Chengdu, China, 610072
    • Sichuan Provincial Peoples Hospital
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Chongqing, China, 400025
    • Southwest Hospital, The Third Military Medical University
  • Fuzhou, China, 350001
    • Fujian Medical University Union Hospital
  • GuangZhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510120
    • SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University
  • Nanjing, China, 210009
    • Jiangsu Cancer Hospital
  • Nanjing, China, 210008
    • NanJing Drum Tower Hospital
  • Ningbo, China, 315010
    • Drug clinical trial ethics committee of Ningbo First Hospital
  • ShangHai, China, 200001
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • ShangHai, China, 200040
    • Shanghai Huadong Hospital
  • ShangHai, China, 200240
    • The Fifth People's Hospital of Shanghai, Fudan University
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200040
    • HuaShan Hospital Fudan University
  • Suzhou, China, 215006
    • The First Affiliated Hospital of Soochow University
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Hospital
  • Wuhan, China, 430014
    • The Central Hospital of Wuhan
  • Wuhan, China, 430030
    • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Wuxi, China, 214023
    • Wuxi People s Hospital
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xian Jiaotong University
• Czechia
  • Hradec Králove, Czechia, 500 05
    • Fakultni Nemocnice Hradec Kralove
  • Liberec, Czechia, 460 63
    • Krajska Nemocnice Liberec
  • Olomouc, Czechia, 77900
    • Uromedical Center s.r.o.
  • Pardubice, Czechia, 53203
    • Multiscan s.r.o.
  • Plzen, Czechia, 305 99
    • Fakultni nemocnice Plzen, Urologicka klinika
  • Praha 2, Czechia, 120 00
    • Urologicka klinika 1.LF UK a VFN
  • Praha 4, Czechia, 140 59
    • Thomayerova nemocnice, Onkologicka klinika
  • Uherske Hradiste, Czechia, 68668
    • Uherskohradistska nemocnice a.s.
• France
  • Besancon, France, 25030
    • CHRU de Besançon
  • Bordeaux, France, 33000
    • Institut Bergonié
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin
  • Lyon, France, 69008
    • Centre Leon Bérard
  • Montpellier, France, 34298
    • Institut Regional du Cancer de Montpellier Val d'Aurelle
  • Nancy, France, 54100
    • Polyclinique de Gentilly
  • Nice Cedex 2, France, 06189
    • Centre Antoine Lacassagne
  • Paris Cedex 15, France, 75908
    • Hopital Europeen Georges-Pompidou
  • Saint Herblain, France, 44805
    • Institut de Cancerologie de l Ouest ICO
  • Saint Mande, France, 94163
    • Hia Begin
  • Strasbourg Cedex, France, 67098
    • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
• Germany
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
  • Duisburg, Germany, 47179
    • Urologicum Duisburg
  • Homburg, Germany, 66424
    • Universitätsklinikum des Saarlandes
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Nuertingen, Germany, 72622
    • Studienpraxis Urologie Drs. Feyerabend
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem, Urológia Klinika
  • Budapest, Hungary, 1122
    • Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Központ
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Nyiregyhaza, Hungary, 4400
    • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
  • Pécs, Hungary, 7621
    • Uro-Clin Kft.
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem
  • Szombathely, Hungary, 9700
    • Markusovszky Egyetemi Oktatokorhaz
• Israel
  • Beer Yaakov, Israel, 60930
    • Asaf Harofe Medical Center
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center Tel Hashomer
• Italy
  • Faenza, Italy, 48018
    • AUSL Romagna - Ospedale di Faenza
  • Milano, Italy, 20132
    • Ospedale San Raffaele
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Napoli, Italy, 80131
    • Oncologia Medica A - Ist Naz Tumori G Pascale
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto Iov Irccs Padova
  • Parma, Italy, 43126
    • Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
  • Perugia, Italy, 06132
    • Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 128
    • Campus Bio-Medico di Roma
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Terni, Italy, 5100
    • Azienda Ospedaliera S. Maria Terni
  • Torino, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza
  • Trento, Italy, 38122
    • Ospedale Santa Chiara Trento
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 443-721
    • Ajou University Hospital
  • Gyeonggi-do, Korea, Republic of, 10408
    • National Cancer Center
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St. Mary'S Hospital
• Malaysia
  • George Town, Malaysia, 10990
    • Hospital Pulau Pinang
  • Johor Bahru, Malaysia, 81100
    • Hospital Sultan Ismail
  • Kota Kinabalu, Malaysia, 88996
    • Hospital Likas
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
• Mexico
  • Aguascalientes, Mexico, 20010
    • iBiomed Research Unit
  • Ciudad de Mexico, Mexico, 03100
    • Mexico Centre for Clinical Research, S.A. de C.V.
  • Durango, Mexico, 34000
    • Consultorio de Especialidad en Urologia Privado
  • Monterrey, Mexico, 64710
    • Avix Investigacion Clinica S C
  • Zapopan, Mexico, 45040
    • Consultorio Privado
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • NKI-AVL, Amsterdam
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Leidschendam, Netherlands, 2262 BA
    • MC Haaglanden Lok Antoniushove - Afd.Interne - INT
  • Nieuwegein, Netherlands, 3430EM
    • St. Antonius Ziekenhuis (St. Antonius Hospital)
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius-Wilhelminaziekenhuis
  • Rotterdam, Netherlands, 3075 EA
    • Erasmus MC
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medical Center
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii im. Prof. F. Lukaszczyka
  • Bydgoszcz, Poland, 85-094
    • Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Sp z o o
  • Lodz, Poland, 93-509
    • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Siedlce, Poland, 08-110
    • Urologica Praktyka Lekarska Adam Marcheluk
  • Szczecin, Poland, 70-111
    • Pomorski Uniwersytet Medyczny w Szczecinie
  • Warszawa, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Wrocław, Poland, 53-413
    • Dolnoslaskie Centrum Onkologii
• Portugal
  • Coimbra, Portugal, 3000-075
    • Hospitais da universidade de Coimbra
  • Coimbra, Portugal, 3000-075
    • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
  • Lisbon, Portugal, 1400-038
    • Champalimaud Foundation Champalimaud Centre
  • Porto, Portugal, 4099-001
    • H. Santo António - Centro Hospitalar do Porto
• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • VA Caribbean Healthcare System
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • Altai Regional Oncology Dispensary
  • Ivanovo, Russian Federation, 153040
    • Ivanovo Regional Oncology Dispensary
  • Kursk, Russian Federation, 305524
    • GUZ Kursk Regional Oncology Dispensary
  • Moscow, Russian Federation, 125130
    • Moscow City Clinical Hospital # 62
  • Moscow, Russian Federation, 117997
    • Russian Scientific Center of Roentgenoradiology
  • Nizhny Novgorod, Russian Federation, 603000
    • Clinical Diagnostic Centre of Nizhny Novgorod Region
  • Omsk, Russian Federation, 644013
    • Clinical Oncology Dispensary
  • Pyatigorsk, Russian Federation, 357500
    • LLC Novaya Clinica
  • Pyatigorsk, Russian Federation, 357502
    • Pyatigorsk Interdistrict Oncology Dispensary
  • Saint Petersburg, Russian Federation, 196603
    • Private Medical Institution Euromedservice
  • Saint-Petersburg, Russian Federation, 191104
    • Leningrad Regional Oncology Dispensary
  • Sankt-Peterburg, Russian Federation, 197758
    • Russian Scientific Center of Radiology and Surgical Technologies
  • Saransk, Russian Federation, 430032
    • Republican Oncology Dispensary
  • Sochi, Russian Federation, 354057
    • Oncologic Dispensary No.2
  • Tambov, Russian Federation, 392013
    • Tambov Regional Oncology Clinical Dispansary
  • Tomsk, Russian Federation, 634050
    • Tomsk Cancer Research Institute
  • Tyumen, Russian Federation, 625000
    • Medical-sanitary unit 'Neftyanik'
  • Vologda, Russian Federation, 160012
    • Vologda Regional Oncological Dispensary
• South Africa
  • Johannesburg, South Africa, 1619
    • Clinresco Centres Pty Ltd
  • Pretoria, South Africa, 0001
    • Clinical Research Unit
• Spain
  • Barcelona, Spain, 08025
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08003
    • Hosp. Del Mar
  • Barcelona, Spain, 08036
    • Hosp. Clinic de Barcelona
  • Coruña, Spain, 15006
    • Hospital Juan Canalejo
  • Jerez de la Frontera, Spain, 11407
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Málaga, Spain, 29010
    • Hosp. Virgen de La Victoria
  • Pozuelo de Alarcon, Spain, 28223
    • Hosp. Quiron Madrid Pozuelo
  • Sabadell, Spain, 08208
    • Corporacio Sanitari Parc Tauli
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
• Sweden
  • Stockholm, Sweden, 11883
    • Södersjukhuset
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset Solna
  • Uppsala, Sweden, 751 85
    • Akademiska sjukhuset
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 403
    • China Medical University Hospital
  • Taichung, Taiwan, 435
    • Tungs' Taichung MetroHarbor Hospital
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center Yong Kang
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 33305
    • Chang Gung Memorial Hospital
• Turkey
  • Adana, Turkey, 01330
    • Cukurova University, Faculty of Medicine
  • Ankara, Turkey, 6560
    • Ankara Bilkent Sehir Hastanesi
  • Ankara, Turkey, 06200
    • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Antalya, Turkey, 07070
    • Akdeniz University Medical Faculty
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34096
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34147
    • Bakirkoy Training and Research Hospital
  • Istanbul, Turkey, 34722
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Izmir, Turkey, 35575
    • IEU Medical Point Hospital
  • Kocaeli, Turkey, 41380
    • Kocaeli University Medical Faculty
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
  • Dnipo, Ukraine, 49005
    • Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
  • Dnipro, Ukraine, 49102
    • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
  • Dnipro, Ukraine, 49100
    • Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
  • Ivano-Frankivsk, Ukraine, 76008
    • Ivano-Frankivsk Regional Clinical Hospital
  • Khakhiv, Ukraine, 61070
    • Municipal non-profit enterprise 'Regional Center of Oncology'
  • Kharkiv, Ukraine, 61037
    • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
  • Kyiv, Ukraine, 03022
    • State Institution National Cancer Institute
  • Kyiv, Ukraine, 03115
    • State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
  • Lviv, Ukraine, 79010
    • Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
  • Poltava, Ukraine, 36024
    • ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
  • Uzhgorod, Ukraine, 88000
    • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
• United Kingdom
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Infirmary
  • London, United Kingdom, WC1E 6DD
    • UCL Cancer Institute
  • Torquay, United Kingdom, TQ2 7AA
    • Torbay Hospital-Devon
  • Truro, United Kingdom, TR1 3LJ
    • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
    • Tucson, Arizona, United States, 85741
      • Urological Associates of Southern Arizona, P.C.
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • California
    • Riverside, California, United States, 92505
      • Kaiser Permanente
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates
    • San Francisco, California, United States, 94158
      • University of California San Francisco
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic Pharm
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Clinical Research
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Healthcare System
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Institute
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Jacksonville
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Division Of Hematology/oncology
  • Illinois
    • Hines, Illinois, United States, 60141
      • Veterans Affairs Medical Ctr
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Fort Wayne Medical Oncology and Hematology
    • Jeffersonville, Indiana, United States, 47130
      • First Urology
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University Of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Rcca Md, Llc
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City Veterans Affairs Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
    • Omaha, Nebraska, United States, 68114
      • Adult Pediatric Urology & Urogynecology, P.C
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Delaware Valley Urology, LLC
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
    • Syracuse, New York, United States, 13210
      • Upstate Cancer Center
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Helios Clinical Research, LLC
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Urology Institute
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster Urology
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
  • Virginia
    • Salem, Virginia, United States, 80113
      • Salem VA Medical Center
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLCC
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)	As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.	Up to 32 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cohort 1: Overall Survival (OS)	Up to 97 months
Cohort 1: Time to Symptomatic Progression	Up to 97 months
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy	Up to 97 months
Observed Plasma Concentrations of Niraparib	Up to 97 months
Observed Plasma Concentrations of Abiraterone	Up to 97 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Up to 96 months
Number of Participants With Treatment-Emergent Adverse Events by Severity	Up to 96 months
Number of Participants With Abnormalities in Laboratory Values	Up to 96 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): October 8, 2021
• Study Completion (Estimated): February 19, 2027

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Poly(ADP-ribose) Polymerase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisone; Niraparib; Abiraterone Acetate
• Other Study ID Numbers: CR108534; 2017-003364-12 (EudraCT Number); 64091742PCR3001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No