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 Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1419AHN
    • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
  • Buenos Aires, Argentina, C1426AGE
    • Centro Oncológico Korben
  • C.a.b.a., Argentina, C1426BOR
    • Hospital Militar Cosme Argerich
  • Caba, Argentina, C1061AAS
    • CIPREC Arenales
  • Caba, Argentina, C1027AAP
    • 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
  • Cordoba, Argentina, 5000
    • Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
  • Cordoba, Argentina, X5800
    • Instituto Médico de Río Cuarto
  • Cordoba, Argentina, XX5016KEH
    • Hospital Privado de Cordoba
  • Cordoba, Argentina, X5000KPH
    • Centro Urologico Profesor Bengio
  • 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
    • Royal Brisbane and Women'S Hospital
  • Hobart, Australia, 7000
    • Royal Hobart Hospital
  • Kurralta Park, Australia, 5037
    • Ashford Cancer Centre
  • 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
  • Bobruisk, Belarus, 213825
    • Bobruisk Interregional Oncological Dispensary
  • Brest, Belarus, 224027
    • Brest Regional Oncology Dispensary
  • Gomel, Belarus, 246012
    • Gomel Regional Clinical Oncology Dispensary
  • Grodno, Belarus, 230017
    • Grodno University Hospital
  • Lesnoy, Belarus, 223040
    • N N Alexandrov National Cancer Centre of Belarus
  • Minsk, Belarus, 220013
    • Minsk city Clinical Oncological Dispensary
  • Mogilev, Belarus, 212018
    • Mogilev Regional Hospital
  • Vitebsk, Belarus, 210603
    • Vitebsk Regional Clinical Hospital
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi, site Notre Dame
  • Haine-St-Paul, Belgium, 7100
    • Jolimont
  • Liege, 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
  • Wilrijk, Belgium, 2610
    • GZA ziekenhuizen
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação 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
  • Florianopolis, Brazil, 88034-000
    • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
  • Fortaleza, Brazil, 60 810180
    • Pronutrir
  • Goiania, Brazil, 74605-070
    • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
  • Ipatinga, Brazil, 35162 189
    • Fundação São 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, 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, 41253-190
    • Hospital Sao Rafael
  • Salvador, Brazil, 40170 110
    • Nucleo de Oncologia da Bahia
  • 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 São 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, 01323-900
    • Real e Benemerita Associacao Portuguesa de Beneficencia
  • 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, 01221-020
    • Instituto do Cancer Arnaldo Vieira de Carvalho
  • Uberlândia, Brazil, 38408-150
    • Centro Oncológico do Triângulo
• Bulgaria
  • Burgas, Bulgaria, 8001
    • MHAT Deva Maria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4004
    • District Oncology Dispensary with In-Patient Stationary - Plovdiv
  • 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, M5G 2M9
      • University Health Network (UHN) Princess Margaret Cancer Centre
  • 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, 430030
    • Sun Yat-Sen University Cancer Center
  • Guangzhou, China, 510180
    • Guangzhou First Municipal People's Hospital
  • Guangzhou, China, 510289
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • 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, 200233
    • Second Affiliated Hospital of Soochow University
  • Suzhou, China, 215006
    • The First Affliated 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 Kralove, Czechia, 500 05
    • FN Hradec Kralove, Urologicka klinika
  • Liberec, Czechia, 460 63
    • Krajská nemocnice Liberec
  • Olomouc, Czechia, 77900
    • Uromedical Center s.r.o.
  • Praha 2, 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
  • Naestved, Denmark, 4700
    • Næstved Hospital
  • Odense, Denmark, DK-5000
    • Odense Universitetshospital
  • Vejle, Denmark, DK-7100
    • Vejle Hospital
• France
  • Angers Cedex 9, France, 49933
    • Institut de Cancerologie de l Ouest ICO
  • Avignon Cedex 9, France, 84918
    • Institut Sainte Catherine
  • Besancon, France, 25030
    • CHRU De Besancon
  • Bordeaux, France, 33000
    • Institut Bergonie
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21000
    • Centre Georges François Leclerc
  • Lille, France, 59020
    • Centre OSCAR LAMBRET
  • Lyon, France, 69008
    • Centre LEON BERARD
  • 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 Cedex, France, 86021
    • CHU De Poitiers
  • Quimper, France, 29000
    • Centre Hopitalier Inter-Communal De Cornouaille
  • Saint Mande, France, 94163
    • HIA Begin
  • Saint-Priest-en-Jarez, France, 42271
    • Institut de Cancérologie de Loire
  • Strasbourg, France, 67000
    • Clinique Sainte Anne
  • Suresnes, France, 32151
    • Hôpital FOCH
  • Tours, France, 37044
    • CHRU De Tours
• Germany
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
  • Dresden, Germany, 01307
    • Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
  • Duisburg, Germany, 47169
    • Urologicum Duisburg
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Koeln, Germany, 50937
    • Universitaetsklinikum Koelnt
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • München, Germany, 81675
    • Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
  • Nuertingen, Germany, 72622
    • Studienpraxis Urologie Drs. Feyerabend
• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem
  • Gyor, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem
  • Tatabanya, Hungary, 2800
    • Szent Borbala Hospital Tatabanya
• Israel
  • Afula, Israel, 1834111
    • Haemek Medical Center - Afula
  • Beer-Sheva, 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
  • Milano, Italy, 20141
    • European Institute of Oncology
  • Milano, Italy, 20132
    • Ospedale San Raffaele
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Napoli, 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
    • Ospedale San Bortolo
• 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, 10408
    • National Cancer Center
  • Gyeonggi-do, Korea, Republic of, 16499
    • Ajou University Hospital
  • 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
  • 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
  • Ciudad de Mexico, Mexico, 3720
    • Centro de Investigación Clínica Gramel S.C.
  • Durango, Mexico, 34000
    • Consultorio de Especialidad en Urologia Privado
  • Leon, Mexico, 37000
    • Consultorio Privado
  • Monterrey, Mexico, 64710
    • i Can Oncology Center
  • Monterrey, Mexico, 64710
    • Avix Investigacion Clinica S C
  • Naucalpan, Mexico, 53100
    • Oncologia Integral Satelite
  • Oaxaca, Mexico, 68020
    • Consultorio de Oncología Médica
  • Zapopan, Mexico, 45040
    • Consultorio Privado
• 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, 85-796
    • Centrum Onkologii im. Prof. F. Lukaszczyka
  • Bydgoszcz, Poland, 85-094
    • Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
  • Bydgoszcz, Poland, 85-048
    • IN VIVO Sp. z o.o
  • 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
  • Warszawa, Poland, 04-073
    • Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
  • Wroclaw, Poland, 53-329
    • Specjalistyczna przychodnia lekarska POLIMED
• Portugal
  • Almada, Portugal, 2805-607
    • Hosp. Garcia de Orta
  • Coimbra, Portugal, 3000075
    • Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.
  • Lisboa, Portugal, 1400-038
    • Fundação Champalimaud
  • Lisboa, Portugal, 1649-035
    • Chln - Hosp. Santa Maria
• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • Puerto Rico Medical Research Center
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • Altai Regional Oncology Dispensary
  • Chelyabinsk, Russian Federation, 454087
    • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
  • Ivanovo, Russian Federation, 153040
    • Ivanovo Regional Oncology Dispensary
  • Moscow, Russian Federation, 125130
    • Moscow City Clinical Hospital # 62
  • Moscow, Russian Federation, 125284
    • Hertzen Oncology Research Institute
  • Nizhny Novgorod, Russian Federation, 603001
    • Privolzhsky District Medical Centre
  • 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
  • Saransk, Russian Federation, 430032
    • Republican Oncology Dispensary
  • Tomsk, Russian Federation, 634050
    • Tomsk Cancer Research Institute
  • Tyumen, Russian Federation, 625041
    • Multifunctional clinical medical center 'Medical city'
  • Ufa, Russian Federation, 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
• Spain
  • A Coruna, 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
  • Sevilla, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Sweden
  • Göteborg, Sweden, 413 45
    • Salgrenska University hospital
  • Malmö, Sweden, 205 02
    • Urologiska Mottagningen
  • Stockholm, Sweden, 11883
    • Sodersjukhuset
  • Stockholm, Sweden, 17164
    • Karolinska Universitetssjukhuset Solna
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung 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, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University 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
  • Adana, Turkey, 01250
    • Adana Baskent Yuregir Hospital
  • Ankara, Turkey, 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey, 06560
    • Gazi University Hospital
  • Ankara, Turkey, 06800
    • Ankara Bilkent City Hospital
  • Ankara, Turkey, 06590
    • Ankara University Medical Faculty
  • Ankara, Turkey, 06200
    • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Bursa, Turkey, 16310
    • Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
  • Istanbul, Turkey, 34722
    • T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
  • Istanbul, Turkey, 34147
    • Bakirkoy Training and Research Hospital
  • Istanbul, Turkey, 34000
    • Istanbul University Istanbul Medical Faculty
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Medical Faculty
  • Izmir, Turkey, 35530
    • Izmir Medical Point Hospital
  • Sakarya, Turkey, 54100
    • Sakarya University Training and Research Hospital
  • Samsun, Turkey, 55200
    • Medical Park Samsun Hastanesi
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
  • 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
  • Kamianske, 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, 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'
  • Vinnitsa, Ukraine, 21029
    • Podilskiy Regional Center of Oncology
  • Zhytomyr, Ukraine, 10002
    • Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region 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, 80211
      • The Urology Center of Colorado
    • 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
    • Saint 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
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • 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
  • 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
  • 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
      • Seattle Cancer Care Alliance
    • 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
Radiographic Progression-free Survival (rPFS)	rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) criteria and Response Evaluation Criteria in Solid Tumors (RECIST 1.1).	Up to 47 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from date of randomization to date of death from any cause.	Up to 78 months
Time to Subsequent Therapy	Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.	Up to 47 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention.	Up to 78 months
Time to Symptomatic Progression	Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs 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; d) cancer-related morbid events; e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.	Up to 47 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): September 23, 2020
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): May 27, 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): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypersensitivity; Prostatic Neoplasms; 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: 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