A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE)

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Castration-sensitive Prostate Cancer
• Intervention / Treatment: Drug: Niraparib; Drug: Abiraterone acetate (AA); Drug: Prednisone; Drug: Placebo for Niraparib

Detailed Description

Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AAP) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib in combination with AAP has been approved for the treatment of BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC). Niraparib is an investigational agent in the Metastatic Castration-Sensitive Prostate Cancer (mCSPC) population. Whether the addition of niraparib to the AAP standard of care may improve initial disease control and long-term outcomes compared with AAP alone in a biomarker selected mCSPC population is being evaluated on this trial. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.

• Study Type: Interventional
• Enrollment (Actual): 696
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1419AHN
    • Asociacion de Beneficencia Hospital Sirio Libanes
  • Buenos Aires, Argentina, C1426AGE
    • Centro Oncológico Korben
  • Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • C.a.b.a., Argentina, C1426BOR
    • Hospital Militar Cosme Argerich
  • Caba, Argentina, C1056ABI
    • CINME Centro de Investigaciones Metabolicas
  • Ciudad Automoma Buenos Aires, Argentina, C1120AAT
    • Centro de Urologia (CDU)
  • Ciudad Autonoma de, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Ciudad de Buenos Aires, Argentina, C1430EGF
    • Clinica Adventista Belgrano
  • Córdoba, Argentina, 5000
    • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Córdoba, Argentina, X5000KPH
    • Centro Urologico Profesor Bengio
  • Córdoba, Argentina, X5800
    • Instituto Médico de Río Cuarto
  • Córdoba, Argentina, XX5016KEH
    • Hospital Privado de Cordoba
  • Mar del Plata, Argentina, B7602CBM
    • Hospital Privado de Comunidad
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigacion Pergamino SA
  • San Salvador de Jujuy, Argentina, Y4600AFW
    • ARS Médica
• Australia
  • Birtinya, Australia, 4575
    • Sunshine Coast University Hospital
  • Darlinghurst, Australia, 2010
    • St Vincent s Hospital Sydney
  • Herston, Australia, 4029
    • Cancer Care Services Clinical Research Unit
  • Hobart, Australia, 7000
    • Royal Hobart Hospital
  • Kurralta Park, Australia, 5037
    • Icon Cancer Centre Kurralta Park
  • Liverpool, Australia, 2170
    • Liverpool Hospital
  • Melbourne, Australia, 3000
    • Peter MacCallum Cancer Centre
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
  • North Ryde, Australia, 2109
    • Macquarie University Hospital
  • South Brisbane, Australia, 4101
    • ICON Cancer Care
  • Subiaco, Australia, 6008
    • St John of God Subiaco Hospital
• Belarus
  • Babruysk, Belarus, 213825
    • Bobruisk Interregional Oncology Dispensary
  • Brest, Belarus, 224027
    • Brest Regional Oncology Dispensary
  • Grodno, Belarus, 230017
    • Grodno University Hospital
  • Homyel, Belarus, 246012
    • Gomel Regional Clinical Oncology Dispensary
  • Lesnoy, Belarus, 223040
    • N N Alexandrov National Cancer Centre of Belarus
  • Minsk, Belarus, 220013
    • Minsk city Clinical Oncological Dispensary
  • Mogilev, Belarus, 212018
    • Mogilev Regional Oncology Dispensary
  • Vitebsk, Belarus, 210603
    • Vitebsk Regional Clinical Oncology Dispensary
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Antwerp, Belgium, 2610
    • ZAS Augustinus
  • Charleroi, Belgium, 6060
    • Grand Hopital De Charleroi Site Les Viviers
  • Haine-St-Paul, Belgium, 7100
    • Jolimont
  • Liège, Belgium, 4000
    • CHC MontLegia
  • Namur, Belgium, 5000
    • CHU UCL Namur - Site Sainte Elisabeth
  • Ottignies, Belgium, 1340
    • Clinique St Pierre
  • Roeselare, Belgium, 8800
    • Algemeen Ziekenhuis Delta
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundacao Pio XII
  • Belo Horizonte, Brazil, 30110-022
    • Cetus Oncologia
  • Belo Horizonte, Brazil, 30130-090
    • PERSONAL Oncologia de Precisao e Personalizada
  • Curitiba, Brazil, 80810 050
    • CIONC Centro Integrado de Oncologia de Curitiba
  • Florianópolis, Brazil, 88034-000
    • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
  • Fortaleza, Brazil, 60 810180
    • Pronutrir
  • Goiânia, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Ipatinga, Brazil, 35162 189
    • Fundacao Sao Francisco Xavier
  • Joinville, Brazil, 89201-260
    • Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra O Cancer
  • Pelotas, Brazil, 96020 080
    • UPCO Unidade de Pesquisa Clinica em Oncologia
  • Porto Alegre, Brazil, 90020-090
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90160-093
    • Hospital Ernesto Dornelles
  • Recife, Brazil, CEP: 50070-460
    • MultiHemo Servicos Medicos S.A
  • 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, 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)
  • Salvador, Brazil, 40170 110
    • Nucleo de Oncologia da Bahia
  • Salvador, Brazil, 41253 190
    • Hospital Sao Rafael
  • 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, 01221 020
    • Instituto do Cancer Arnaldo Vieira de Carvalho
  • 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
  • São Paulo, Brazil, 01323 900
    • Real e Benemerita Associacao Portuguesa de Beneficencia
  • Uberlândia, Brazil, 38408-150
    • Centro Oncológico do Triângulo
• Bulgaria
  • Burgas, Bulgaria, 8001
    • MHAT Deva Maria
  • Pleven, Bulgaria, 5800
    • UMHAT Dr Georgi Stranski EAD 1
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center - Plovdiv EOOD
  • Sofia, Bulgaria, 1756
    • Specialized Hospital for Active Treatment in Oncology
  • Sofia, Bulgaria, 1797
    • UMHAT Sofia Med
  • Sofia, Bulgaria, 1330
    • Multifunctional Hospital for Active Treatment for Women Health Nadezhda
  • Vratsa, Bulgaria, 3001
    • Comprehensive Cancer Center
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Prostate Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
    • 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, K7L2V7
      • Kingston Health Sciences Centre, Kingston General Health Research Institute
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Center
    • Toronto, Ontario, Canada, M5G2M9
      • Princess Margaret Cancer Centre University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • McGill University - Jewish General Hospital
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Universite de Montreal
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China, 100191
    • Beijing University Third Hospital
  • Beijing, China, 100050
    • Beijing Friendship Hospital Capital Medical University
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Chengdu, China, 610083
    • Western Theater General Hospital of the Chinese People's Liberation Army
  • Chengdu, China, 610072
    • Sichuan Provincial Peoples Hospital
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Chongqing, China, 400038
    • Southwest Hospital, The Third Military Medical University
  • Guangzhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510289
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Guangzhou, China, 430030
    • Sun Yat Sen University Cancer Center
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital
  • Nanchang, China, 330006
    • The First Affiliated Hospital of NanChang University
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 210000
    • Jiangsu Province Cancer Hospital
  • Ningbo, China, 315010
    • The First Affiliated Hospital of Ningbo University
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200040
    • Huashan Hospital Fudan University
  • Shanghai, China, 200400
    • Huadong Hospital Affiliated to Fudan University
  • Shanghai, China, 200240
    • The Fifth People's Hospital of Shanghai, Fudan University
  • Shanghai, China, 200127
    • Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
  • Shenyang, China, 110004
    • Shengjing Hospital Of China Medical University
  • Suzhou, China, 215006
    • The First Affliated Hospital of Soochow University
  • Suzhou, China, 200233
    • Second Affiliated Hospital of Soochow University
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430030
    • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xian Jiaotong University
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Hradec Králové, Czechia, 500 05
    • FN Hradec Kralove, Urologicka klinika
  • Liberec, Czechia, 460 63
    • Krajská nemocnice Liberec
  • Olomouc, Czechia, 77900
    • Uromedical Center s.r.o.
  • Prague, Czechia, 128 00
    • Urologicka klinika 1 LF UK a VFN
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital
  • Herlev, Denmark, DK-2730
    • Herlev Hospital
  • Næstved, Denmark, 4700
    • Næstved Hospital
  • Odense, Denmark, DK-5000
    • Odense Universitetshospital
  • Vejle, Denmark, DK-7100
    • Vejle Hospital
• France
  • Angers, France, 49933
    • Institut de Cancerologie de l Ouest ICO
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Besançon, France, 25030
    • CHRU De Besancon
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21000
    • Centre Georges Francois Leclerc
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz
  • Montpellier, France, 34298
    • Institut Regional du Cancer de Montpellier Val d'Aurelle
  • Nancy, France, 54100
    • Polyclinique de Gentilly
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Quimper, France, 29000
    • Centre Hopitalier Inter-Communal De Cornouaille
  • Saint-Mandé, France, 94163
    • HIA Begin
  • Saint-Priest-en-Jarez, France, 42271
    • Institut de Cancérologie de Loire
  • Strasbourg, France, 67000
    • Clinique Sainte Anne
  • Suresnes, France, 32151
    • Hopital Foch
  • Tours, France, 37044
    • CHRU de Tours
• Germany
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
  • Cologne, Germany, 50937
    • Universitaetsklinikum Koelnt
  • Dresden, Germany, 01307
    • Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
  • Duisburg, Germany, 47169
    • Urologicum Duisburg
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • München, Germany, 81675
    • Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie Drs. Feyerabend
• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Győr, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • Miskolc, Hungary, 3526
    • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem
  • Tatabánya, Hungary, 2800
    • Szent Borbala Hospital Tatabanya
• Israel
  • Afula, Israel, 1834111
    • Haemek Medical Center - Afula
  • Beersheba, Israel, 85101
    • Soroka Hospital
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Jerusalem, Israel, 91200
    • Hadassah Hospital
  • Petach Tikvah, Israel, 49100
    • Rabin Medical Center, Beilinson Hospital
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center Tel Hashomer
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Arezzo, Italy, 52100
    • Ospedale S. Donato - Asl 8 Arezzo
  • Candiolo, Italy, 10060
    • Divisione di Oncologia - Istituto per la ricerca e cura del cancro
  • Cremona, Italy, 26100
    • Istituti Ospitalieri di Cremona, AO di Cremona
  • Lecce, Italy, 73100
    • Azienda Ospedaliera ''Vito Fazzi''
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20141
    • European Institute of Oncology
  • Naples, Italy, 80138
    • Fondazione G Pascale Istituto Nazionale Tumori IRCCS
  • Orbassano, Italy, 10043
    • Aou San Luigi Gonzaga
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto Iov Irccs Padova
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Pozzuoli, Italy, 80078
    • ASL Napoli 2 Nord-SM delle Grazie Hospital
  • San Giovanni Rotondo, Italy, 71013
    • Casa Sollievo Della Sofferenza IRCCS
  • Trento, Italy
    • Ospedale S. Chiara
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo
• Malaysia
  • George Town, Malaysia, 10990
    • Hospital Pulau Pinang
  • Johor Bahru, Malaysia, 81100
    • Hospital Sultan Ismail
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuching, Malaysia, 93586
    • Sarawak General Hospital
  • Putrajaya, Malaysia, 62250
    • Institut Kanser Negara Clinical Research Center
• Mexico
  • Durango, Mexico, 34000
    • Consultorio de Especialidad en Urologia Privado
  • León, Mexico, 37000
    • Consultorio Privado
  • Mexico City, Mexico, 3720
    • Centro de Investigacion Clínica Gramel S.C.1
  • Monterrey, Mexico, 64710
    • i Can Oncology Center
  • Monterrey, Mexico, 64710
    • Avix Investigacion Clinica S C
  • Naucalpan, Mexico, 53100
    • Oncologia Integral Satelite
  • Oaxaca City, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca
  • Zapopan, Mexico, 45040
    • Consultorio Privado 1
• Netherlands
  • Delft, Netherlands, 2625 AD
    • Reinier de Graaf Gasthuis
  • Hilversum, Netherlands, 1213XZ
    • Tergooiziekenhuizen
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius-Wilhelminaziekenhuis
  • Tilburg, Netherlands, 5022 GC
    • Elisabeth-TweeSteden Ziekenhuis
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Christchurch, New Zealand, 8013
    • Canterbury Urology Research Trust
  • Dunedin Central, New Zealand, 9016
    • Dunedin Hospital
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital
• Poland
  • Bydgoszcz, Poland, 85 048
    • IN VIVO Sp. z o.o
  • Bydgoszcz, Poland, 85 094
    • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
  • Bydgoszcz, Poland, 85 796
    • Centrum Onkologii im Prof F Lukaszczyka
  • Gdynia, Poland, 81 519
    • Szpitale Pomorskie Sp z o o
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED Roman Karaszewski
  • Krakow, Poland, 30 539
    • Klinika MedTrials
  • Lodz, Poland, 93-509
    • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Lublin, Poland, 20-223
    • Medisport
  • Siedlce, Poland, 08-110
    • Urologica Praktyka Lekarska Adam Marcheluk
  • Warsaw, Poland, 04 073
    • Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
  • Wroclaw, Poland, 53-329
    • Specjalistyczna przychodnia lekarska POLIMED
• Portugal
  • Almada, Portugal, 2805-607
    • Uls Almada Seixal - Hosp. Garcia de Orta
  • Coimbra, Portugal, 3000075
    • Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.
  • Lisbon, Portugal, 1400-038
    • Fund. Champalimaud
  • Lisbon, Portugal, 1649 035
    • Uls Santa Maria - Hosp. Santa Maria
• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • Puerto Rico Medical Research Center
• Russia
  • Barnaul, Russia, 656045
    • Altai Regional Oncology Dispensary
  • Chelyabinsk, Russia, 454087
    • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
  • Ivanovo, Russia, 153040
    • Ivanovo Regional Oncology Dispensary
  • Moscow, Russia, 125130
    • Moscow City Clinical Hospital # 62
  • Moscow, Russia, 125284
    • Hertzen Oncology Research Institute
  • Nizhny Novgorod, Russia, 603001
    • Privolzhsky District Medical Centre
  • 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, 191104
    • Leningrad Regional Oncology Dispensary
  • Saransk, Russia, 430032
    • Republican Oncology Dispensary
  • Tomsk, Russia, 634050
    • Tomsk Cancer Research Institute
  • Tyumen, Russia, 625041
    • Multifunctional clinical medical center 'Medical city'
  • Ufa, Russia, 450083
    • Bashkir State Medical University
• South Africa
  • Cape Town, South Africa, 7700
    • CancerCare Rondebosch
  • Pretoria, South Africa, 0001
    • Steve Biko Academic Hospital
  • Vosloorus, South Africa, 1475
    • East Rand Urology 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
  • 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 Mary s Hospital
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Suwon, South Korea, 16499
    • Ajou University Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hosp Univ A Coruna
  • Barcelona, Spain, 08025
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Castellon, Spain, 12004
    • Hosp. Gral. Univ. de Castellon
  • Girona, Spain, 17007
    • Institut Català D'Oncologia Girona
  • Jerez de la Frontera, Spain, 11407
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28006
    • Hosp. Univ. de La Princesa
  • Madrid, Spain, 28660
    • Hosp. Univ. Hm Monteprincipe
  • Málaga, Spain, 29010
    • Hosp Virgen de La Victoria
  • Sabadell, Spain, 08208
    • Corporacio Sanitari Parc Tauli
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Sweden
  • Gothenburg, Sweden, 413 45
    • Salgrenska University hospital
  • Malmö, Sweden, 205 02
    • Urologiska Mottagningen
  • Stockholm, Sweden, 11883
    • Sodersjukhuset
  • Stockholm, Sweden, 17164
    • Karolinska Universitetssjukhuset Solna
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 435
    • Tungs' Taichung MetroHarbor Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Chang-Gung Memorial Hospital, LinKou Branch
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Adana Baskent Yuregir Hospital
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Sehir Hastanesi
  • Ankara, Turkey (Türkiye), 06590
    • Ankara University Medical Faculty
  • Ankara, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06560
    • Gazi Hastanesi
  • Bursa, Turkey (Türkiye), 16310
    • Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Training and Research Hospital
  • Istanbul, Turkey (Türkiye), 34000
    • Istanbul University Istanbul Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
  • Istanbul, Turkey (Türkiye), 34722
    • T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
  • Izmir, Turkey (Türkiye), 35530
    • Izmir Medical Point Hospital
  • Izmir, Turkey (Türkiye), 35340
    • Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi
  • Sakarya, Turkey (Türkiye), 54050
    • Sakarya Üniversitesi Tıp Fakültesi Hastanesi
  • Samsun, Turkey (Türkiye), 55200
    • Medical Park Samsun Hastanesi
• Ukraine
  • Cherkasy, Ukraine, 18009
    • CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
  • Chernivtsi, Ukraine, 58013
    • Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
  • 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
  • Dnipro, Ukraine, 49005
    • Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
  • Ivano-Frankivsk, Ukraine, 76008
    • Ivano-Frankivsk Regional Clinical Hospital
  • Kamyanske, Ukraine, 51900
    • Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
  • Khakhiv, Ukraine, 61070
    • Municipal non-profit enterprise 'Regional Center of Oncology'
  • Kharkiv, Ukraine, 61037
    • Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
  • Kherson, Ukraine, 73035
    • Kherson Regional Oncological Dispensary
  • Kyiv, Ukraine, 04107
    • Kyiv Regional Oncological Dispensary
  • 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
    • Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
  • Vinnitsa, Ukraine, 21029
    • Podilskiy Regional Center of Oncology
  • Zhytomyr, Ukraine, 10002
    • Municipal non-profit enterprise Zhytomyr Regional Oncology Dispensary of Zhytomyr Regional Council
• United Kingdom
  • Bangor, United Kingdom, LL57 2PW
    • Ysbyty Gwynedd
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • Brighton, United Kingdom, BN2 5BE
    • Brighton and Sussex University Hospitals NHS Trust
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Great Maze Pond, United Kingdom, SE1 9RT
    • Guy's Hospital
  • Grimsby, United Kingdom, DN33 2BA
    • Prince of Wales Hospital
  • Hillingdon, United Kingdom, HA6 2RN
    • Marie Curie Research Wing - Mount Vernon Hospital
  • Inverness, United Kingdom, IV2 3UJ
    • Raigmore Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHSFT
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
  • Truro, United Kingdom, TR1 3LJ
    • Royal Cornwall Hospitals NHS Trust - Royal Cornwall 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.
  • California
    • Los Angeles, California, United States, 90073
      • Greater Los Angeles VA Healthcare System
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates
    • San Francisco, California, United States, 94158
      • University of San Francisco California
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers
    • Denver, Colorado, United States, 80210
      • AdventHealth Medical Group Urology of Denver
    • Lakewood, Colorado, United States, 80228
      • Colorado Clinical Research
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology & Oncology Assoc.
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Advanced Urology Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Jacksonville
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • Urology of Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology, PA
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Associates
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • Missouri
    • Saint Joseph, Missouri, United States, 64507
      • Mosaic Life Care
    • St Louis, Missouri, United States, 63109
      • St. Louis VA Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research Network
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai
    • New York, New York, United States, 10010
      • Manhattan VAMC
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VAMC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System
    • Salem, Oregon, United States, 97301
      • Oregon Oncology Specialists
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Keystone Urology Specialists
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia VA Medical Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center (UPMC)
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson Veterans Affairs Medical Center
    • Seneca, South Carolina, United States, 29672
      • Prisma Health
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology-Austin
    • Denton, Texas, United States, 76201
      • Texas Oncology - Northeast
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • New Braunfels, Texas, United States, 78130
      • Texas Oncology P A
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Northeast 1
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Huntsman Cancer Institute
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University - Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Healthcare System
    • Tacoma, Washington, United States, 98405
      • MultiCare Health System

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria:

• Pathological diagnosis of prostate adenocarcinoma
• Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
• Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
• Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase
• Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation and 1 surgical intervention for symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal cord compression or obstructive symptoms). Participants with radiation or surgical interventions to all known sites of metastatic disease will be excluded from trial participation. Radiation must be completed prior to randomization (b) Up to a maximum of 6 months of ADT prior to randomization; (c) Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to randomization (d) Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to randomization

Exclusion criteria:

• Prior treatment with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARP inhibitor)
• History of adrenal dysfunction
• Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
• History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Niraparib with Abiraterone Acetate plus Prednisone (AAP); Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.	Drug: Niraparib; Participants will receive Niraparib 200 mg once daily.; Drug: Abiraterone acetate (AA); Participants will receive AA 1000 mg once daily.; Drug: Prednisone; Participants will receive prednisone 5 mg once daily.
Active Comparator: AA plus Prednisone (AAP); Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.	Drug: Abiraterone acetate (AA); Participants will receive AA 1000 mg once daily.; Drug: Prednisone; Participants will receive prednisone 5 mg once daily.; Drug: Placebo for Niraparib; Participants will receive matching placebo for Niraparib once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator	rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (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. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later.	From date of randomization (Day -3 to Day 1) up to approximately 49 months
HRR Effector Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator	rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per 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. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later.	From date of randomization (Day -3 to Day 1) up to approximately 49 months
All HRR: Radiographic Progression-free Survival (rPFS) Assessed by Investigator	rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per 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. A confirmatory scan with >=2 new lesions indicated progression; A confirmatory scan not showing >=2 new lesions means no progression. If Week 8 scan shows <2 new bone lesions compared to baseline, first scan with >=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan >=6 weeks later.	From date of randomization (Day -3 to Day 1) up to approximately 49 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BRCA Subgroup: Time to Symptomatic Progression	Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.	From date of randomization (Day -3 to Day 1) up to approximately 49 months
HRR Effector Subgroup: Time to Symptomatic Progression	Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.	From date of randomization (Day -3 to Day 1) up to approximately 49 months
All HRR: Time to Symptomatic Progression	Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture [symptomatic and/or pathologic], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.	From date of randomization (Day -3 to Day 1) up to approximately 49 months
Overall Survival (OS)		From date of randomization (Day -3 to Day 1) up to 83 months
Time to Subsequent Therapy		From date of randomization (Day -3 to Day 1) up to 83 months
Number of Participants With Treatment-emergent Serious Adverse Events		From Cycle 1 Day 1 up to 83 months
Number of Participants With Treatment-emergent Adverse Events by Severity		From Cycle 1 Day 1 up to 83 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

• Attard G, Agarwal N, Graff JN, Sandhu S, Efstathiou E, Ozguroglu M, Pereira de Santana Gomes AJ, Vianna K, Luo H, Gotto GT, Cheng HH, Kim W, Varela CR, Schaeffer D, Kramer K, Li S, Baron B, Shen F, Mundle SD, McCarthy SA, Olmos D, Chi KN, Rathkopf DE. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025 Dec;31(12):4109-4118. doi: 10.1038/s41591-025-03961-8. Epub 2025 Oct 7.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): January 7, 2025
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

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; Immune System Diseases; Prostatic Neoplasms; Hypersensitivity; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Androstenes; Androstanes; Abiraterone Acetate; Prednisone; niraparib
• Other Study ID Numbers: CR108852; 2020-002209-25 (EudraCT Number); 67652000PCR3002 (Other Identifier: Janssen Research & Development, LLC); 2023-506365-64-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No