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)
4 other identifiers
interventional
696
32 countries
379
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Longer than P75 for phase_3
379 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedStudy Start
First participant enrolled
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2025
CompletedResults Posted
Study results publicly available
January 22, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
ExpectedApril 13, 2026
April 1, 2026
4.3 years
July 31, 2020
January 6, 2026
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
BRCA Subgroup: Time to Symptomatic Progression
From date of randomization (Day -3 to Day 1) up to approximately 49 months
HRR Effector Subgroup: Time to Symptomatic Progression
From date of randomization (Day -3 to Day 1) up to approximately 49 months
All HRR: Time to Symptomatic Progression
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
- +2 more secondary outcomes
Study Arms (2)
Niraparib with Abiraterone Acetate plus Prednisone (AAP)
EXPERIMENTALParticipants 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.
AA plus Prednisone (AAP)
ACTIVE COMPARATORParticipants 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.
Interventions
Participants will receive matching placebo for Niraparib once daily.
Participants will receive Niraparib 200 mg once daily.
Participants will receive AA 1000 mg once daily.
Participants will receive prednisone 5 mg once daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (387)
Urology Centers Of Alabama
Homewood, Alabama, 35209, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, 85741, United States
Greater Los Angeles VA Healthcare System
Los Angeles, California, 90073, United States
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
University of San Francisco California
San Francisco, California, 94158, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907, United States
AdventHealth Medical Group Urology of Denver
Denver, Colorado, 80210, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Eastern Connecticut Hematology & Oncology Assoc.
Norwich, Connecticut, 06360, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, 33308, United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32209, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Urology of Indiana
Greenwood, Indiana, 46143, United States
First Urology
Jeffersonville, Indiana, 47130, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044, United States
Chesapeake Urology Associates
Towson, Maryland, 21204, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Mosaic Life Care
Saint Joseph, Missouri, 64507, United States
St. Louis VA Medical Center
St Louis, Missouri, 63109, United States
GU Research Network
Omaha, Nebraska, 68130, United States
New York Oncology Hematology
Albany, New York, 12206, United States
Manhattan VAMC
New York, New York, 10010, United States
Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Durham VAMC
Durham, North Carolina, 27705, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
VA Portland Health Care System
Portland, Oregon, 97239, United States
Oregon Oncology Specialists
Salem, Oregon, 97301, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604, United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15232, United States
Ralph H. Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401, United States
Prisma Health
Seneca, South Carolina, 29672, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Texas Oncology-Austin
Austin, Texas, 78731, United States
Texas Oncology - Northeast
Denton, Texas, 76201, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Texas Oncology P A
New Braunfels, Texas, 78130, United States
Texas Oncology - Northeast 1
Tyler, Texas, 75702, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298, United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
CIPREC
Buenos Aires, C1061AAS, Argentina
Asociacion de Beneficencia Hospital Sirio Libanes
Buenos Aires, C1419AHN, Argentina
Centro Oncológico Korben
Buenos Aires, C1426AGE, Argentina
Hospital Militar Cosme Argerich
C.a.b.a., C1426BOR, Argentina
CINME Centro de Investigaciones Metabolicas
Caba, C1056ABI, Argentina
Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires, C1120AAT, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de, C1199ABB, Argentina
Clinica Adventista Belgrano
Ciudad de Buenos Aires, C1430EGF, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Instituto Médico de Río Cuarto
Córdoba, X5800, Argentina
Hospital Privado de Cordoba
Córdoba, XX5016KEH, Argentina
Hospital Privado de Comunidad
Mar del Plata, B7602CBM, Argentina
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM, Argentina
ARS Médica
San Salvador de Jujuy, Y4600AFW, Argentina
Sunshine Coast University Hospital
Birtinya, 4575, Australia
St Vincent s Hospital Sydney
Darlinghurst, 2010, Australia
Cancer Care Services Clinical Research Unit
Herston, 4029, Australia
Royal Hobart Hospital
Hobart, 7000, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037, Australia
Liverpool Hospital
Liverpool, 2170, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Macquarie University Hospital
North Ryde, 2109, Australia
ICON Cancer Care
South Brisbane, 4101, Australia
St John of God Subiaco Hospital
Subiaco, 6008, Australia
Bobruisk Interregional Oncology Dispensary
Babruysk, 213825, Belarus
Brest Regional Oncology Dispensary
Brest, 224027, Belarus
Grodno University Hospital
Grodno, 230017, Belarus
Gomel Regional Clinical Oncology Dispensary
Homyel, 246012, Belarus
N N Alexandrov National Cancer Centre of Belarus
Lesnoy, 223040, Belarus
Minsk city Clinical Oncological Dispensary
Minsk, 220013, Belarus
Mogilev Regional Oncology Dispensary
Mogilev, 212018, Belarus
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603, Belarus
ZNA Middelheim
Antwerp, 2020, Belgium
ZAS Augustinus
Antwerp, 2610, Belgium
Grand Hopital De Charleroi Site Les Viviers
Charleroi, 6060, Belgium
Jolimont
Haine-St-Paul, 7100, Belgium
CHC MontLegia
Liège, 4000, Belgium
CHU UCL Namur - Site Sainte Elisabeth
Namur, 5000, Belgium
Clinique St Pierre
Ottignies, 1340, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
Cetus Oncologia
Belo Horizonte, 30110-022, Brazil
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, 30130-090, Brazil
CIONC Centro Integrado de Oncologia de Curitiba
Curitiba, 80810 050, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, 88034-000, Brazil
Pronutrir
Fortaleza, 60 810180, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, 74605-070, Brazil
Fundacao Sao Francisco Xavier
Ipatinga, 35162 189, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Joinville, 89201-260, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59075-740, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas, 96020 080, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-093, Brazil
MultiHemo Servicos Medicos S.A
Recife, CEP: 50070-460, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20230-130, Brazil
Universidade do Estado do Rio de Janeiro - UERJ
Rio de Janeiro, 20551-030, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250 905, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775 001, Brazil
Nucleo de Oncologia da Bahia
Salvador, 40170 110, Brazil
Hospital Sao Rafael
Salvador, 41253 190, Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, 01221 020, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, 01221-020, Brazil
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01236-030, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 900, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01421-000, Brazil
Núcleo de Pesquisa São Camilo
São Paulo, 04014-002, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo, 04039-004, Brazil
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba, 18030-005, Brazil
Centro Oncológico do Triângulo
Uberlândia, 38408-150, Brazil
MHAT Deva Maria
Burgas, 8001, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD 1
Pleven, 5800, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004, Bulgaria
Multifunctional Hospital for Active Treatment for Women Health Nadezhda
Sofia, 1330, Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia, 1756, Bulgaria
UMHAT Sofia Med
Sofia, 1797, Bulgaria
Comprehensive Cancer Center
Vratsa, 3001, Bulgaria
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
Kelowna, British Columbia, V1Y 5L3, Canada
British Columbia Cancer Agency BCCA Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
British Columbia Cancer Agency Vancouver Island Centre
Victoria, British Columbia, V8R 6V5, Canada
McMaster Institute of Urology
Hamilton, Ontario, L8N 4A6, Canada
Kingston Health Sciences Centre, Kingston General Health Research Institute
Kingston, Ontario, K7L2V7, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G2M9, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9, Canada
McGill University - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking University First Hospital
Beijing, 100034, China
Beijing Friendship Hospital Capital Medical University
Beijing, 100050, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing University Third Hospital
Beijing, 100191, China
Beijing Hospital
Beijing, 100730, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
Western Theater General Hospital of the Chinese People's Liberation Army
Chengdu, 610083, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Southwest Hospital, The Third Military Medical University
Chongqing, 400038, China
Sun Yat Sen University Cancer Center
Guangzhou, 430030, China
Guangzhou First Municipal People's Hospital
Guangzhou, 510180, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510289, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Jiangsu Province Cancer Hospital
Nanjing, 210000, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Huashan Hospital Fudan University
Shanghai, 200040, China
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
Shanghai, 200127, China
The Fifth People's Hospital of Shanghai, Fudan University
Shanghai, 200240, China
Huadong Hospital Affiliated to Fudan University
Shanghai, 200400, China
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
Second Affiliated Hospital of Soochow University
Suzhou, 200233, China
The First Affliated Hospital of Soochow University
Suzhou, 215006, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
FN Hradec Kralove, Urologicka klinika
Hradec Králové, 500 05, Czechia
Krajská nemocnice Liberec
Liberec, 460 63, Czechia
Uromedical Center s.r.o.
Olomouc, 77900, Czechia
Urologicka klinika 1 LF UK a VFN
Prague, 128 00, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Copenhagen University Hospital
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, DK-2730, Denmark
Næstved Hospital
Næstved, 4700, Denmark
Odense Universitetshospital
Odense, DK-5000, Denmark
Vejle Hospital
Vejle, DK-7100, Denmark
Institut de Cancerologie de l Ouest ICO
Angers, 49933, France
Institut Sainte Catherine
Avignon, 84918, France
CHRU De Besancon
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Centre Oscar Lambret
Lille, 59000, France
Centre Leon Berard
Lyon, 69008, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Institut Regional du Cancer de Montpellier Val d'Aurelle
Montpellier, 34298, France
Polyclinique de Gentilly
Nancy, 54100, France
CHU De Poitiers
Poitiers, 86021, France
Centre Hopitalier Inter-Communal De Cornouaille
Quimper, 29000, France
HIA Begin
Saint-Mandé, 94163, France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 42271, France
Clinique Sainte Anne
Strasbourg, 67000, France
Hopital Foch
Suresnes, 32151, France
CHRU de Tours
Tours, 37044, France
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig, 38126, Germany
Universitaetsklinikum Koelnt
Cologne, 50937, Germany
Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
Dresden, 01307, Germany
Urologicum Duisburg
Duisburg, 47169, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
München, 81675, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Studienpraxis Urologie Drs. Feyerabend
Nürtingen, 72622, Germany
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526, Hungary
Szegedi Tudomanyegyetem
Szeged, 6720, Hungary
Szent Borbala Hospital Tatabanya
Tatabánya, 2800, Hungary
Haemek Medical Center - Afula
Afula, 1834111, Israel
Soroka Hospital
Beersheba, 85101, Israel
Rambam Medical Center
Haifa, 31096, Israel
Hadassah Hospital
Jerusalem, 91200, Israel
Rabin Medical Center, Beilinson Hospital
Petach Tikvah, 49100, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Ospedale S. Donato - Asl 8 Arezzo
Arezzo, 52100, Italy
Divisione di Oncologia - Istituto per la ricerca e cura del cancro
Candiolo, 10060, Italy
Istituti Ospitalieri di Cremona, AO di Cremona
Cremona, 26100, Italy
Azienda Ospedaliera ''Vito Fazzi''
Lecce, 73100, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
European Institute of Oncology
Milan, 20141, Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, 80138, Italy
Aou San Luigi Gonzaga
Orbassano, 10043, Italy
Istituto Oncologico Veneto Iov Irccs Padova
Padova, 35128, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli, 80078, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
Ospedale S. Chiara
Trento, Italy
Ospedale San Bortolo
Vicenza, 36100, Italy
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Institut Kanser Negara Clinical Research Center
Putrajaya, 62250, Malaysia
Consultorio de Especialidad en Urologia Privado
Durango, 34000, Mexico
Consultorio Privado
León, 37000, Mexico
Centro de Investigación Clínica Gramel S.C.1
Mexico City, 3720, Mexico
Avix Investigacion Clinica S C
Monterrey, 64710, Mexico
i Can Oncology Center
Monterrey, 64710, Mexico
Oncologia Integral Satelite
Naucalpan, 53100, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
Consultorio Privado 1
Zapopan, 45040, Mexico
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
Tergooiziekenhuizen
Hilversum, 1213XZ, Netherlands
Canisius-Wilhelminaziekenhuis
Nijmegen, 6532 SZ, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC, Netherlands
Auckland City Hospital
Auckland, 1023, New Zealand
Canterbury Urology Research Trust
Christchurch, 8013, New Zealand
Dunedin Hospital
Dunedin Central, 9016, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
IN VIVO Sp. z o.o
Bydgoszcz, 85 048, Poland
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
Bydgoszcz, 85 094, Poland
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, 85 796, Poland
Szpitale Pomorskie Sp z o o
Gdynia, 81 519, Poland
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, 62-500, Poland
Klinika MedTrials
Krakow, 30 539, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-509, Poland
Medisport
Lublin, 20-223, Poland
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, 08-110, Poland
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
Warsaw, 04 073, Poland
Specjalistyczna przychodnia lekarska POLIMED
Wroclaw, 53-329, Poland
Uls Almada Seixal - Hosp. Garcia de Orta
Almada, 2805-607, Portugal
Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.
Coimbra, 3000075, Portugal
Fund. Champalimaud
Lisbon, 1400-038, Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 035, Portugal
Puerto Rico Medical Research Center
Hato Rey, 00917, Puerto Rico
Altai Regional Oncology Dispensary
Barnaul, 656045, Russia
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
Chelyabinsk, 454087, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Moscow City Clinical Hospital # 62
Moscow, 125130, Russia
Hertzen Oncology Research Institute
Moscow, 125284, Russia
Privolzhsky District Medical Centre
Nizhny Novgorod, 603001, Russia
Clinical Oncology Dispensary
Omsk, 644013, Russia
LLC Novaya Clinica
Pyatigorsk, 357500, Russia
Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk, 357502, Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, 191104, Russia
Private Medical Institution Euromedservice
Saint Petersburg, 196603, Russia
Republican Oncology Dispensary
Saransk, 430032, Russia
Tomsk Cancer Research Institute
Tomsk, 634050, Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041, Russia
Bashkir State Medical University
Ufa, 450083, Russia
CancerCare Rondebosch
Cape Town, 7700, South Africa
Steve Biko Academic Hospital
Pretoria, 0001, South Africa
East Rand Urology Research Unit
Vosloorus, 1475, South Africa
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Gral. Univ. de Castellon
Castellon, 12004, Spain
Institut Català D'Oncologia Girona
Girona, 17007, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Hm Monteprincipe
Madrid, 28660, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 08208, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Salgrenska University hospital
Gothenburg, 413 45, Sweden
Urologiska Mottagningen
Malmo, 205 02, Sweden
Sodersjukhuset
Stockholm, 11883, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 17164, Sweden
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung, 435, Taiwan
National Taiwan University Hospital.
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, 333, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Adana Baskent Yuregir Hospital
Adana, 01250, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 06200, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Gazi Hastanesi
Ankara, 06560, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06590, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
Bursa, 16310, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34000, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
Istanbul, 34098, Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi
Izmir, 35340, Turkey (Türkiye)
Izmir Medical Point Hospital
Izmir, 35530, Turkey (Türkiye)
Sakarya Üniversitesi Tıp Fakültesi Hastanesi
Sakarya, 54050, Turkey (Türkiye)
Medical Park Samsun Hastanesi
Samsun, 55200, Turkey (Türkiye)
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
Cherkasy, 18009, Ukraine
Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
Chernivtsi, 58013, Ukraine
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
Dnipro, 49005, Ukraine
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
Dnipro, 49100, Ukraine
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro, 49102, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008, Ukraine
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
Kamyanske, 51900, Ukraine
Municipal non-profit enterprise 'Regional Center of Oncology'
Khakhiv, 61070, Ukraine
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
Kharkiv, 61037, Ukraine
Kherson Regional Oncological Dispensary
Kherson, 73035, Ukraine
State Nonprofit Enterprise National Cancer Institute
Kyiv, 03022, Ukraine
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
Kyiv, 03115, Ukraine
Kyiv Regional Oncological Dispensary
Kyiv, 04107, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010, Ukraine
Podilskiy Regional Center of Oncology
Vinnitsa, 21029, Ukraine
Municipal non-profit enterprise Zhytomyr Regional Oncology Dispensary of Zhytomyr Regional Council
Zhytomyr, 10002, Ukraine
Ysbyty Gwynedd
Bangor, LL57 2PW, United Kingdom
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Guy's Hospital
Great Maze Pond, SE1 9RT, United Kingdom
Prince Of Wales Hospital
Grimsby, DN33 2BA, United Kingdom
Marie Curie Research Wing - Mount Vernon Hospital
Hillingdon, HA6 2RN, United Kingdom
Raigmore Hospital
Inverness, IV2 3UJ, United Kingdom
University College London Hospitals NHSFT
London, NW1 2PG, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Related Publications (1)
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.
PMID: 41057655DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Executive Director Clinical Prostate
- Organization
- Janssen Research and Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 4, 2020
Study Start
September 23, 2020
Primary Completion
January 7, 2025
Study Completion (Estimated)
November 1, 2027
Last Updated
April 13, 2026
Results First Posted
January 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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