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: Abiraterone Acetate; Drug: Prednisone; Drug: Placebo; Drug: New Formulation of Niraparib and Abiraterone Acetate (AA); Drug: Niraparib

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 Oncológico Korben
  • Buenos Aires, Argentina, C1431FWN
    • CEMIC Saavedra
  • Ciudad Automoma Buenos Aires, Argentina, C1120AAT
    • Centro de Urologia (CDU)
  • Córdoba, Argentina, X5016KEH
    • Hospital Privado Centro Medico de Cordoba
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Mar del Plata, Argentina, B7602CBM
    • Hospital Privado de Comunidad
  • Mar del Plata, Argentina, B7600FZN
    • Instituto de Investigaciones Clinicas Mar del Plata
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigacion Pergamino SA
  • Rosario, Argentina, 2000
    • Sanatorio Britanico de Rosario
  • Rosario, Argentina, S2000SDV
    • Sanatorio Parque
  • San Salvador de Jujuy, Argentina, Y4600AFW
    • ARS Médica
• 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
  • Antwerp, Belgium, 2610
    • ZAS Augustinus
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi, site Notre Dame
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Liège, Belgium, B-4000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Merksem, Belgium, 2170
    • ZNA Jan Palfijn
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundacao Pio XII
  • Belo Horizonte, Brazil, 30130-090
    • PERSONAL Oncologia de Precisao e Personalizada
  • Brasília, 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
  • Goiânia, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Ijuí, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Ipatinga, Brazil, 35162 189
    • Fundacao Sao Francisco Xavier
  • Joinville, Brazil, 89201-260
    • Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
  • Maceió, Brazil, 57052-765
    • Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
  • Natal, Brazil, 59062 000
    • Liga Norte Riograndense Contra O Cancer
  • 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, 20551-030
    • Universidade do Estado do Rio de Janeiro - UERJ
  • Rio de Janeiro, Brazil, 22250 905
    • Oncoclinicas Rio de Janeiro S A
  • Rio de Janeiro, Brazil, 22775 001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Rio de Janeiro, Brazil, 20230 130
    • Ministerio da Saude Instituto Nacional do Cancer
  • Salvador, Brazil, 40050-410
    • Hospital Santa Isabel
  • Santo André, Brazil, 09060 870
    • Fundacao do ABC Centro Universitario FMABC
  • 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, 01236-030
    • Instituto de Ensino e Pesquisa São Lucas
  • São Paulo, Brazil, 04502-001
    • Instituto D Or de Pesquisa e Ensino IDOR
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 04039-004
    • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  • São Paulo, Brazil, 01246 000
    • Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
  • São Paulo, Brazil, 01221-020
    • Irmandade Santa Casa de Misericordia de Sao Paulo
  • São Paulo, Brazil, 01421-000
    • Hospital Alemao Oswaldo Cruz
  • Três 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, M5G2M9
      • Princess Margaret Cancer Centre University Health Network
  • 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, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University
  • 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
  • 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
    • Krajská nemocnice Liberec
  • Olomouc, Czechia, 77900
    • Uromedical Center s.r.o.
  • Pardubice, Czechia, 53203
    • Multiscan s.r.o.
  • Pilsen, Czechia, 305 99
    • Fakultni nemocnice Plzen, Urologicka klinika
  • Prague, Czechia, 120 00
    • Urologicka klinika 1 LF UK a VFN
  • Prague, Czechia, 140 59
    • Thomayerova nemocnice, Onkologicka klinika
  • Uherské Hradiště, Czechia, 68668
    • Uherskohradistska nemocnice a.s.
• France
  • Besançon, France, 25030
    • CHRU De Besancon
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Montpellier, France, 34298
    • Institut Regional du Cancer de Montpellier Val d'Aurelle
  • Nancy, France, 54100
    • Polyclinique de Gentilly
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75908
    • Hopital Europeen Georges-Pompidou
  • Saint-Herblain, France, 44805
    • Institut de Cancerologie de l Ouest ICO
  • Saint-Mandé, France, 94163
    • HIA Begin
  • Strasbourg, 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
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Nürtingen, 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 Kozpont
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
  • Pécs, Hungary, 7621
    • Uro-Clin Kft.
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem 1
  • 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
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Naples, 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, 00168
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Roma, Italy, 128
    • Campus Bio Medico di Roma
  • Terni, Italy, 5100
    • Azienda Ospedaliera S. Maria Terni
  • Torino, Italy, 10126
    • A.O.U. Città della Salute e della Scienza
  • Trento, Italy, 38122
    • Ospedale Santa Chiara Trento
• 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
  • Durango, Mexico, 34000
    • Consultorio de Especialidad en Urologia Privado
  • Mexico City, Mexico, 03100
    • Mexico Centre for Clinical Research, S.A. de C.V.
  • Monterrey, Mexico, 64710
    • Avix Investigacion Clinica S C
  • Zapopan, Mexico, 45040
    • Consultorio Privado
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Antoni van Leeuwenhoek
  • 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, 85 094
    • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
  • Bydgoszcz, Poland, 85 796
    • Centrum Onkologii im Prof F Lukaszczyka
  • Gdansk, Poland, 80 214
    • Uniwersyteckie Centrum Kliniczne
  • Gdynia, Poland, 81 519
    • Szpitale Pomorskie Sp z o o
  • Lodz, Poland, 93-509
    • Wojewodzki 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
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Wroclaw, 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
  • Lisbon, Portugal, 1400-038
    • Champalimaud Foundation Champalimaud Centre
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
  • Porto, Portugal, 4099-001
    • H. Santo António - Centro Hospitalar do Porto
• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • VA Caribbean Healthcare System
• Russia
  • Barnaul, Russia, 656045
    • Altai Regional Oncology Dispensary
  • Ivanovo, Russia, 153040
    • Ivanovo Regional Oncology Dispensary
  • Kursk, Russia, 305524
    • GUZ Kursk Regional Oncology Dispensary
  • Moscow, Russia, 117997
    • Russian Scientific Center of Roentgenoradiology
  • Moscow, Russia, 125130
    • Moscow City Clinical Hospital # 62
  • Nizhny Novgorod, Russia, 603000
    • Clinical Diagnostic Centre of Nizhny Novgorod Region
  • Omsk, Russia, 644013
    • Clinical Oncology Dispensary
  • Pyatigorsk, Russia, 357500
    • LLC Novaya Clinica
  • Pyatigorsk, Russia, 357502
    • Pyatigorsk Interdistrict Oncology Dispensary
  • Saint Petersburg, Russia, 196603
    • Private Medical Institution Euromedservice
  • Saint Petersburg, Russia, 197758
    • Russian Scientific Center of Radiology and Surgical Technologies
  • Saint Petersburg, Russia, 191104
    • Leningrad Regional Oncology Dispensary
  • Saransk, Russia, 430032
    • Republican Oncology Dispensary
  • Sochi, Russia, 354057
    • Oncologic Dispensary No.2
  • Tambov, Russia, 392013
    • Tambov Regional Oncology Clinical Dispansary
  • Tomsk, Russia, 634050
    • Tomsk Cancer Research Institute
  • Tyumen, Russia, 625000
    • Medical-sanitary unit 'Neftyanik'
  • Vologda, Russia, 160012
    • Vologda Regional Oncological Dispensary
• South Africa
  • Johannesburg, South Africa, 1619
    • Clinresco Centres Pty Ltd
  • Pretoria, South Africa, 0001
    • Clinical Research Unit
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Daegu, South Korea, 42601
    • Keimyung University Dongsan Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Daejeon, South Korea, 35015
    • Chungnam national university hospital
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Gyeonggi-do, South Korea, 443-721
    • Ajou University Hospital
  • Seongnam-si, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
• Spain
  • A Coruña, Spain, 15006
    • Hospital Juan Canalejo
  • Barcelona, Spain, 08025
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08003
    • Hosp. Del Mar
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • 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 Alarcón, 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
    • Sodersjukhuset
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset Solna
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
• Taiwan
  • Kaohsiung City, 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 (Türkiye)
  • Adana, Turkey (Türkiye), 01330
    • Cukurova University, Faculty of Medicine
  • Ankara, Turkey (Türkiye), 06200
    • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Ankara, Turkey (Türkiye), 6560
    • Ankara Bilkent Sehir Hastanesi
  • Antalya, Turkey (Türkiye), 07070
    • Akdeniz University Medical Faculty
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34722
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Training and Research Hospital
  • Izmir, Turkey (Türkiye), 35575
    • IEU Medical Point Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli University Medical Faculty
• Ukraine
  • Cherkasy, Ukraine, 18009
    • CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
  • 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, 03115
    • State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
  • Kyiv, Ukraine, 03022
    • State Nonprofit Enterprise National Cancer Institute
  • Lviv, Ukraine, 79010
    • University Hospital of SNA Danylo Halytsky LMNU
  • Poltava, Ukraine, 36024
    • ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
  • Uzhhorod, 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: 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.; Drug: Niraparib; Participants will receive niraparib 200 mg capsules or tablets once daily.; Other Names: JNJ-64091742
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: 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.; Drug: Niraparib; Participants will receive niraparib 200 mg capsules or tablets once daily.; Other Names: JNJ-64091742
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 occurred 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
Cohort 1 Breast Cancer Gene (BRCA) Subgroup: 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 occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan >=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 <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

Publications and helpful links

General Publications

• Roubaud G, Attard G, Boegemann M, Olmos D, Trevisan M, Antoni L, Pascoe K, Capone C, Van Sanden S, Hashim M, Palmer S, Chi K. Adjustment for imbalances in baseline characteristics in the MAGNITUDE phase 3 study confirms the clinical benefit of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic prostate cancer. Eur J Cancer. 2024 Sep;209:114183. doi: 10.1016/j.ejca.2024.114183. Epub 2024 Jun 17.
• Chi KN, Rathkopf D, Smith MR, Efstathiou E, Attard G, Olmos D, Lee JY, Small EJ, Pereira de Santana Gomes AJ, Roubaud G, Saad M, Zurawski B, Sakalo V, Mason GE, Francis P, Wang G, Wu D, Diorio B, Lopez-Gitlitz A, Sandhu S; MAGNITUDE Principal Investigators. Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2023 Jun 20;41(18):3339-3351. doi: 10.1200/JCO.22.01649. Epub 2023 Mar 23.
• Rathkopf DE, Roubaud G, Chi KN, Efstathiou E, Attard G, Olmos D, Small EJ, Saad M, Castro E, Kim W, Wu D, Bertzos K, Dibaj S, Zhang J, Francis P, Smith MR. Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial. Eur Urol. 2025 Oct;88(4):359-369. doi: 10.1016/j.eururo.2024.09.003. Epub 2024 Sep 23.
• De Santis M, Breijo SM, Robinson P, Capone C, Pascoe K, Van Sanden S, Hashim M, Trevisan M, Daly C, Reitsma F, van Beekhuizen S, Ruan H, Heeg B, Verzoni E. Feasibility of Indirect Treatment Comparisons Between Niraparib Plus Abiraterone Acetate and Other First-Line Poly ADP-Ribose Polymerase Inhibitor Treatment Regimens for Patients with BRCA1/2 Mutation-Positive Metastatic Castration-Resistant Prostate Cancer. Adv Ther. 2024 Aug;41(8):3039-3058. doi: 10.1007/s12325-024-02918-6. Epub 2024 Jul 3.
• Ye D, Saad M, Lee JY, Jung W, Pang ST, Li L, Gurney H, Attard G, Chi KN, Mundle S, Zhuo J, Singh A, Lin Y, Sandhu S. Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study. Int J Urol. 2026 Apr;33(4):e70455. doi: 10.1111/iju.70455.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): October 8, 2021
• Study Completion (Estimated): February 27, 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): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Androstenes; Androstanes; Abiraterone Acetate; Prednisone; niraparib
• Other Study ID Numbers: CR108534; 2017-003364-12 (EudraCT Number); 64091742PCR3001 (Other Identifier: Janssen Research & Development, LLC); 2023-503254-12-00 (Registry Identifier: EUCT number)

Drug and device information, study documents

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