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)

NCT ID: NCT04497844

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 696 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2027-11-01

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).

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.

Conditions

Metastatic Castration-sensitive Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Niraparib

Intervention Type: DRUG

Participants will receive Niraparib 200 mg once daily.

Abiraterone acetate (AA)

Intervention Type: DRUG

Participants will receive AA 1000 mg once daily.

Prednisone

Intervention Type: DRUG

Participants will receive prednisone 5 mg once daily.

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.

Group Type: ACTIVE_COMPARATOR

Abiraterone acetate (AA)

Intervention Type: DRUG

Participants will receive AA 1000 mg once daily.

Prednisone

Intervention Type: DRUG

Participants will receive prednisone 5 mg once daily.

Placebo for Niraparib

Intervention Type: DRUG

Participants will receive matching placebo for Niraparib once daily.

Interventions

Niraparib

Participants will receive Niraparib 200 mg once daily.

Intervention Type: DRUG

Abiraterone acetate (AA)

Participants will receive AA 1000 mg once daily.

Intervention Type: DRUG

Prednisone

Participants will receive prednisone 5 mg once daily.

Intervention Type: DRUG

Placebo for Niraparib

Participants will receive matching placebo for Niraparib once daily.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Urology Centers Of Alabama

Homewood, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

Urological Associates of Southern Arizona, P.C.

Tucson, Arizona, United States

Greater Los Angeles VA Healthcare System

Los Angeles, California, United States

University of California Irvine Medical Center Chao Family Comprehensive Cancer Center

Orange, California, United States

San Bernardino Urological Associates

San Bernardino, California, United States

University of San Francisco California

San Francisco, California, United States

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

AdventHealth Medical Group Urology of Denver

Denver, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Eastern Connecticut Hematology & Oncology Assoc.

Norwich, Connecticut, United States

Advanced Urology Institute

Daytona Beach, Florida, United States

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, United States

University of Florida Health Jacksonville

Jacksonville, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Urology of Indiana

Greenwood, Indiana, United States

First Urology

Jeffersonville, Indiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Baltimore VA Medical Center

Baltimore, Maryland, United States

Maryland Oncology Hematology, PA

Columbia, Maryland, United States

Chesapeake Urology Associates

Towson, Maryland, United States

Michigan Institute of Urology

Troy, Michigan, United States

Mosaic Life Care

Saint Joseph, Missouri, United States

St. Louis VA Medical Center

St Louis, Missouri, United States

GU Research Network

Omaha, Nebraska, United States

New York Oncology Hematology

Albany, New York, United States

Manhattan VAMC

New York, New York, United States

Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Associated Medical Professionals

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Durham VAMC

Durham, North Carolina, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

VA Portland Health Care System

Portland, Oregon, United States

Oregon Oncology Specialists

Salem, Oregon, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Ralph H. Johnson Veterans Affairs Medical Center

Charleston, South Carolina, United States

Prisma Health

Seneca, South Carolina, United States

Urology Associates

Nashville, Tennessee, United States

Texas Oncology-Austin

Austin, Texas, United States

Texas Oncology - Northeast

Denton, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Texas Oncology P A

New Braunfels, Texas, United States

Texas Oncology - Northeast

Tyler, Texas, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, United States

VA Puget Sound Healthcare System

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

MultiCare Health System

Tacoma, Washington, United States

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

Buenos Aires, , Argentina

Centro Oncológico Korben

Buenos Aires, , Argentina

Hospital Militar Cosme Argerich

C.a.b.a., , Argentina

CINME Centro de Investigaciones Metabolicas

Caba, , Argentina

CIPREC Arenales

CABA, , Argentina

Centro de Urologia (CDU)

Ciudad Automoma Buenos Aires, , Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de, , Argentina

Clinica Adventista Belgrano

Ciudad de Buenos Aires, , Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, , Argentina

Centro Urologico Profesor Bengio

Córdoba, , Argentina

Instituto Médico de Río Cuarto

Córdoba, , Argentina

Hospital Privado de Cordoba

Córdoba, , Argentina

Hospital Privado de Comunidad

Mar del Plata, , Argentina

Centro de Investigacion Pergamino SA

Pergamino, , Argentina

ARS Médica

San Salvador de Jujuy, , Argentina

Sunshine Coast University Hospital

Birtinya, , Australia

St Vincent s Hospital Sydney

Darlinghurst, , Australia

Cancer Care Services Clinical Research Unit

Herston, , Australia

Royal Hobart Hospital

Hobart, , Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, , Australia

Liverpool Hospital

Liverpool, , Australia

Peter MacCallum Cancer Centre

Melbourne, , Australia

Fiona Stanley Hospital

Murdoch, , Australia

Macquarie University Hospital

North Ryde, , Australia

ICON Cancer Care

South Brisbane, , Australia

St John of God Subiaco Hospital

Subiaco, , Australia

Bobruisk Interregional Oncology Dispensary

Babruysk, , Belarus

Brest Regional Oncology Dispensary

Brest, , Belarus

Grodno University Hospital

Grodno, , Belarus

Gomel Regional Clinical Oncology Dispensary

Homyel, , Belarus

N N Alexandrov National Cancer Centre of Belarus

Lesnoy, , Belarus

Minsk city Clinical Oncological Dispensary

Minsk, , Belarus

Mogilev Regional Oncology Dispensary

Mogilev, , Belarus

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, , Belarus

ZNA Middelheim

Antwerp, , Belgium

Grand Hopital De Charleroi Site Les Viviers

Charleroi, , Belgium

Jolimont

Haine-St-Paul, , Belgium

CHC MontLegia

Liège, , Belgium

CHU UCL Namur - Site Sainte Elisabeth

Namur, , Belgium

Clinique St Pierre

Ottignies, , Belgium

Algemeen Ziekenhuis Delta

Roeselare, , Belgium

GZA Ziekenhuizen

Wilrijk, , Belgium

Fundacao Pio XII

Barretos, , Brazil

Cetus Oncologia

Belo Horizonte, , Brazil

PERSONAL Oncologia de Precisao e Personalizada

Belo Horizonte, , Brazil

CIONC Centro Integrado de Oncologia de Curitiba

Curitiba, , Brazil

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, , Brazil

Pronutrir

Fortaleza, , Brazil

Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

Goiânia, , Brazil

Fundacao Sao Francisco Xavier

Ipatinga, , Brazil

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, , Brazil

Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Hospital Ernesto Dornelles

Porto Alegre, , Brazil

MultiHemo Servicos Medicos S.A

Recife, , Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, , Brazil

Universidade do Estado do Rio de Janeiro - UERJ

Rio de Janeiro, , Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, , Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, , Brazil

Nucleo de Oncologia da Bahia

Salvador, , Brazil

Hospital Sao Rafael

Salvador, , Brazil

Fundacao do ABC Centro Universitario FMABC

Santo André, , Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, , Brazil

Irmandade Santa Casa de Misericordia de Sao Paulo

São Paulo, , Brazil

Instituto de Ensino e Pesquisa São Lucas

São Paulo, , Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, , Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, , Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

Núcleo de Pesquisa São Camilo

São Paulo, , Brazil

Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

São Paulo, , Brazil

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, , Brazil

Centro Oncológico do Triângulo

Uberlândia, , Brazil

MHAT Deva Maria

Burgas, , Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

Complex Oncology Center - Plovdiv EOOD

Plovdiv, , Bulgaria

Multifunctional Hospital for Active Treatment for Women Health Nadezhda

Sofia, , Bulgaria

Specialized Hospital for Active Treatment in Oncology

Sofia, , Bulgaria

UMHAT Sofia Med

Sofia, , Bulgaria

Comprehensive Cancer Center

Vratsa, , Bulgaria

Prostate Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)

Kelowna, British Columbia, Canada

British Columbia Cancer Agency BCCA Vancouver Centre

Vancouver, British Columbia, Canada

British Columbia Cancer Agency Vancouver Island Centre

Victoria, British Columbia, Canada

McMaster Institute of Urology

Hamilton, Ontario, Canada

Kingston Health Sciences Centre, Kingston General Health Research Institute

Kingston, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

McGill University - Jewish General Hospital

Montreal, Quebec, Canada

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Peking University First Hospital

Beijing, , China

Beijing Friendship Hospital Capital Medical University

Beijing, , China

Beijing Cancer Hospital

Beijing, , China

Beijing University Third Hospital

Beijing, , China

Beijing Hospital

Beijing, , China

West China Hospital of Sichuan University

Chengdu, , China

Sichuan Provincial Peoples Hospital

Chengdu, , China

Western Theater General Hospital of the Chinese People's Liberation Army

Chengdu, , China

Chongqing University Cancer Hospital

Chongqing, , China

Southwest Hospital, The Third Military Medical University

Chongqing, , China

Sun Yat Sen University Cancer Center

Guangzhou, , China

Guangzhou First Municipal People's Hospital

Guangzhou, , China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, , China

Zhejiang Provincial People's Hospital

Hangzhou, , China

The First Affiliated Hospital of NanChang University

Nanchang, , China

Jiangsu Province Cancer Hospital

Nanjing, , China

Nanjing Drum Tower Hospital

Nanjing, , China

The First Affiliated Hospital of Ningbo University

Ningbo, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Huashan Hospital Fudan University

Shanghai, , China

Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

Shanghai, , China

The Fifth People's Hospital of Shanghai, Fudan University

Shanghai, , China

Huadong Hospital Affiliated to Fudan University

Shanghai, , China

Shengjing Hospital Of China Medical University

Shenyang, , China

Second Affiliated Hospital of Soochow University

Suzhou, , China

The First Affliated Hospital of Soochow University

Suzhou, , China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Wuhan, , China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, , China

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

FN Hradec Kralove, Urologicka klinika

Hradec Králové, , Czechia

Krajská nemocnice Liberec

Liberec, , Czechia

Uromedical Center s.r.o.

Olomouc, , Czechia

Urologicka klinika 1 LF UK a VFN

Prague, , Czechia

Aalborg University Hospital

Aalborg, , Denmark

Copenhagen University Hospital

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Næstved Hospital

Næstved, , Denmark

Odense Universitetshospital

Odense, , Denmark

Vejle Hospital

Vejle, , Denmark

Institut de Cancerologie de l Ouest ICO

Angers, , France

Institut Sainte Catherine

Avignon, , France

CHRU De Besancon

Besançon, , France

Institut Bergonie

Bordeaux, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Georges Francois Leclerc

Dijon, , France

Centre Oscar Lambret

Lille, , France

Centre Leon Berard

Lyon, , France

Hopital Prive Jean Mermoz

Lyon, , France

Institut Regional du Cancer de Montpellier Val d'Aurelle

Montpellier, , France

Polyclinique de Gentilly

Nancy, , France

CHU De Poitiers

Poitiers, , France

Centre Hopitalier Inter-Communal De Cornouaille

Quimper, , France

HIA Begin

Saint-Mandé, , France

Institut de Cancérologie de Loire

Saint-Priest-en-Jarez, , France

Clinique Sainte Anne

Strasbourg, , France

Hopital Foch

Suresnes, , France

CHRU de Tours

Tours, , France

Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

Braunschweig, , Germany

Universitaetsklinikum Koelnt

Cologne, , Germany

Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

Dresden, , Germany

Urologicum Duisburg

Duisburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

München, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Studienpraxis Urologie Drs. Feyerabend

Nürtingen, , Germany

Jahn Ferenc Del-pesti Korhaz es Rendelointezet

Budapest, , Hungary

Debreceni Egyetem

Debrecen, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, , Hungary

Szegedi Tudomanyegyetem

Szeged, , Hungary

Szent Borbala Hospital Tatabanya

Tatabánya, , Hungary

Haemek Medical Center - Afula

Afula, , Israel

Soroka Hospital

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Hadassah Hospital

Jerusalem, , Israel

Rabin Medical Center, Beilinson Hospital

Petach Tikvah, , Israel

Sheba Medical Center Tel Hashomer

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Ospedale S. Donato - Asl 8 Arezzo

Arezzo, , Italy

Divisione di Oncologia - Istituto per la ricerca e cura del cancro

Candiolo, , Italy

Istituti Ospitalieri di Cremona, AO di Cremona

Cremona, , Italy

Azienda Ospedaliera ''Vito Fazzi''

Lecce, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Ospedale San Raffaele

Milan, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

European Institute of Oncology

Milan, , Italy

Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Napoli, , Italy

Aou San Luigi Gonzaga

Orbassano, , Italy

Istituto Oncologico Veneto Iov Irccs Padova

Padua, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

ASL Napoli 2 Nord-SM delle Grazie Hospital

Pozzuoli, , Italy

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, , Italy

Ospedale S. Chiara

Trento, , Italy

Ospedale San Bortolo

Vicenza, , Italy

Hospital Pulau Pinang

George Town, , Malaysia

Hospital Sultan Ismail

Johor Bahru, , Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Sarawak General Hospital

Kuching, , Malaysia

Institut Kanser Negara Clinical Research Center

Putrajaya, , Malaysia

Consultorio de Especialidad en Urologia Privado

Durango, , Mexico

Consultorio Privado

León, , Mexico

Centro de Investigación Clínica Gramel S.C.

Mexico City, , Mexico

Avix Investigacion Clinica S C

Monterrey, , Mexico

i Can Oncology Center

Monterrey, , Mexico

Oncologia Integral Satelite

Naucalpan, , Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, , Mexico

Consultorio Privado

Zapopan, , Mexico

Reinier de Graaf Gasthuis

Delft, , Netherlands

Tergooiziekenhuizen

Hilversum, , Netherlands

Canisius-Wilhelminaziekenhuis

Nijmegen, , Netherlands

Elisabeth-TweeSteden Ziekenhuis

Tilburg, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Canterbury Urology Research Trust

Christchurch, , New Zealand

Dunedin Hospital

Dunedin Central, , New Zealand

Tauranga Hospital

Tauranga, , New Zealand

IN VIVO Sp. z o.o

Bydgoszcz, , Poland

Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

Bydgoszcz, , Poland

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, , Poland

Szpitale Pomorskie Sp z o o

Gdynia, , Poland

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, , Poland

Klinika MedTrials

Krakow, , Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, , Poland

Medisport

Lublin, , Poland

Urologica Praktyka Lekarska Adam Marcheluk

Siedlce, , Poland

Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

Warsaw, , Poland

Specjalistyczna przychodnia lekarska POLIMED

Wroclaw, , Poland

Uls Almada Seixal - Hosp. Garcia de Orta

Almada, , Portugal

Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.

Coimbra, , Portugal

Fund. Champalimaud

Lisbon, , Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, , Portugal

Puerto Rico Medical Research Center

Hato Rey, , Puerto Rico

Altai Regional Oncology Dispensary

Barnaul, , Russia

Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

Chelyabinsk, , Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, , Russia

Moscow City Clinical Hospital # 62

Moscow, , Russia

Hertzen Oncology Research Institute

Moscow, , Russia

Privolzhsky District Medical Centre

Nizhny Novgorod, , Russia

Clinical Oncology Dispensary

Omsk, , Russia

LLC Novaya Clinica

Pyatigorsk, , Russia

Pyatigorsk Interdistrict Oncology Dispensary

Pyatigorsk, , Russia

Leningrad Regional Oncology Dispensary

Saint Petersburg, , Russia

Private Medical Institution Euromedservice

Saint Petersburg, , Russia

Republican Oncology Dispensary

Saransk, , Russia

Tomsk Cancer Research Institute

Tomsk, , Russia

Multifunctional clinical medical center 'Medical city'

Tyumen, , Russia

Bashkir State Medical University

Ufa, , Russia

CancerCare Rondebosch

Cape Town, , South Africa

Steve Biko Academic Hospital

Pretoria, , South Africa

East Rand Urology Research Unit

Vosloorus, , South Africa

Pusan National University Hospital

Busan, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Keimyung University Dongsan Hospital

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

National Cancer Center

Gyeonggi-do, , South Korea

Ajou University Hospital

Gyeonggi-do, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , South Korea

Hosp Univ A Coruna

A Coruña, , Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Hosp Clinic de Barcelona

Barcelona, , Spain

Hosp. Gral. Univ. de Castellon

Castellon, , Spain

Institut Català D'Oncologia Girona

Girona, , Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, , Spain

Hosp. Univ. de La Princesa

Madrid, , Spain

Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. Hm Monteprincipe

Madrid, , Spain

Hosp Virgen de La Victoria

Málaga, , Spain

Corporacio Sanitari Parc Tauli

Sabadell, , Spain

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

Hosp. Clinico Univ. de Valencia

Valencia, , Spain

Salgrenska University hospital

Gothenburg, , Sweden

Urologiska Mottagningen

Malmo, , Sweden

Sodersjukhuset

Stockholm, , Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Tungs' Taichung MetroHarbor Hospital

Taichung, , Taiwan

National Taiwan University Hospital.

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, , Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Ramathibodi Hospital

Bangkok, , Thailand

Siriraj Hospital

Bangkok, , Thailand

Adana Baskent Yuregir Hospital

Adana, , Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Gazi University Hospital

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi

Bursa, , Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

Istanbul, , Turkey (Türkiye)

Bakirkoy Training and Research Hospital

Istanbul, , Turkey (Türkiye)

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, , Turkey (Türkiye)

Izmir Medical Point Hospital

Izmir, , Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, , Turkey (Türkiye)

Medical Park Samsun Hastanesi

Samsun, , Turkey (Türkiye)

CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC

Cherkasy, , Ukraine

Municipal Non-profit enterprise 'Bukovinian clinical oncology center'

Chernivtsi, , Ukraine

Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

Dnipro, , Ukraine

Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

Dnipro, , Ukraine

Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

Dnipro, , Ukraine

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, , Ukraine

Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

Kamianske, , Ukraine

Municipal non-profit enterprise 'Regional Center of Oncology'

Khakhiv, , Ukraine

Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

Kharkiv, , Ukraine

Kherson Regional Oncological Dispensary

Kherson, , Ukraine

Nonprofit Organization National Cancer Institute

Kyiv, , Ukraine

State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

Kyiv, , Ukraine

Kyiv Regional Oncological Dispensary

Kyiv, , Ukraine

Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

Lviv, , Ukraine

Podilskiy Regional Center of Oncology

Vinnitsa, , Ukraine

Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

Zhytomyr, , Ukraine

Ysbyty Gwynedd

Bangor, , United Kingdom

Belfast City Hospital

Belfast, , United Kingdom

Brighton and Sussex University Hospitals NHS Trust

Brighton, , United Kingdom

Bristol Haematology and Oncology Centre

Bristol, , United Kingdom

Guy's Hospital

Great Maze Pond, , United Kingdom

Prince Of Wales Hospital

Grimsby, , United Kingdom

Marie Curie Research Wing - Mount Vernon Hospital

Hillingdon, , United Kingdom

Raigmore Hospital

Inverness, , United Kingdom

University College London Hospitals NHSFT

London, , United Kingdom

Churchill Hospital

Oxford, , United Kingdom

Royal Preston Hospital

Preston, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

Truro, , United Kingdom

Countries

United States; Argentina; Australia; Belarus; Belgium; Brazil; Bulgaria; Canada; China; Czechia; Denmark; France; Germany; Hungary; Israel; Italy; Malaysia; Mexico; Netherlands; New Zealand; Poland; Portugal; Puerto Rico; Russia; South Africa; South Korea; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 41057655 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

67652000PCR3002

Identifier Type: OTHER

Identifier Source: secondary_id

2020-002209-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506365-64-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108852

Identifier Type: -

Identifier Source: org_study_id