A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Castration-Resistant Prostatic Cancer Clinical Trial

— MAGNITUDE  

Official title:

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03748641
• Other study ID #: CR108534
• Secondary ID: 2017-003364-1264
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 25, 2019
• Est. completion date: February 19, 2027

Study information

• Verified date: May 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Description:

This study will assess efficacy and safety of niraparib in combination with AAP for the treatment of participants with metastatic castration resistant prostate cancer. Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. AA is a pro-drug of abiraterone and selectively inhibits the enzyme 17 alpha-hydroxylase/C17,20-lyase (CYP17), which is found in the testes and adrenals, as well as in prostate tissues and tumors. In participants with metastatic prostate cancer, DNA-repair anomalies are identified in approximately 15 percent (%) to 20% of tumors. The study will consist of 5 phases: a prescreening phase for biomarker evaluation only, a screening phase, a treatment phase, a follow up phase, and an extension phase (either open-label extension [OLE] or long-term extension [LTE]). During the prescreening phase participants will be evaluated for homologous recombination repair (HRR) gene alteration status and then will be assigned to one of the 2 cohorts based on their biomarker status. Treatment will be administered daily and is planned to be continuous until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. Efficacy, pharmacokinetics, biomarkers, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 66 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 765
• Est. completion date: February 19, 2027
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HRR gene alteration (as identified by the sponsor's required assays) as follows:

1. Cohort 1: positive for HRR gene alteration

2. Cohort 2: not positive for DRD (that is, HRR gene alteration)

3. Cohort 3: eligible by HRR status

• Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)

• Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy

• Able to continue GnRHa during the study if not surgically castrate

• Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion Criteria:

• Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor

• Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting

• Symptomatic brain metastases

• History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)

• Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Related Conditions & MeSH terms

• Castration-Resistant Prostatic Cancer
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• Niraparib
Participants will receive niraparib 200 mg capsules once daily.
• Abiraterone Acetate
Participants will receive AA 1000 mg tablets once daily.
• Prednisone
Participants will receive prednisone 10 mg tablets daily.
• Placebo
Participants will receive matching placebo once daily.
• New Formulation of Niraparib and Abiraterone Acetate (AA)
Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.

Locations

Country	Name	City	State
Argentina	Centro Oncológico Korben	Buenos Aires
Argentina	Hospital Aleman	Buenos Aires
Argentina	Centro de Urologia (CDU)	Ciudad Automoma Buenos Aires
Argentina	CEMIC Saavedra	Ciudad Autonoma de Buenos Aires
Argentina	Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica	Cordoba
Argentina	Hospital Privado - Centro Medico de Cordoba	Cordoba
Argentina	Hospital Privado de Comunidad	Mar Del Plata
Argentina	Instituto de Investigaciones Clinicas Mar del Plata	Mar Del Plata, Buenos Aires
Argentina	Centro de Investigacion Pergamino SA	Pergamino
Argentina	Sanatorio Britanico de Rosario	Rosario
Argentina	Sanatorio Parque	Rosario
Argentina	ARS Médica	San Salvador De Jujuy
Australia	Royal Adelaide Hospital	Adelaide
Australia	Pindara Private Hospital	Benowa
Australia	Sunshine Coast University Hospital	Birtinya
Australia	Princess Alexandra Hospital	Brisbane
Australia	St. Vincent's Hospital Sydney	Darlinghurst
Australia	Royal Hobart Hospital	Hobart
Australia	Macquarie University	Macquarie University
Australia	Eye Surgery Associates	Malvern
Australia	Peter MacCallum Cancer Centre	Melbourne
Australia	Fiona Stanley Hospital	Murdoch
Australia	Hollywood Private Hospital	Nedlands
Australia	Prince Of Wales Hospital	Randwick
Australia	Sydney Adventist Hospital	Wahroonga
Australia	Wollongong Private Hospital	Wollongong
Belgium	OLV Ziekenhuis Aalst	Aalst
Belgium	ZNA Middelheim	Antwerpen
Belgium	Grand Hopital de Charleroi, site Notre Dame	Charleroi
Belgium	AZ Maria Middelares	Gent
Belgium	Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman	Liege
Belgium	ZNA Jan Palfijn	Merksem
Brazil	Fundacao Pio XII	Barretos
Brazil	PERSONAL Oncologia de Precisao e Personalizada	Belo Horizonte
Brazil	Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia	Brasilia
Brazil	CIONC Centro Integrado de Oncologia de Curitiba	Curitiba
Brazil	Pronutrir	Fortaleza
Brazil	Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge	Goiania
Brazil	Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda	Ijui
Brazil	Fundação São Francisco Xavier	Ipatinga
Brazil	Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia	Joinville
Brazil	Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.	Maceio
Brazil	Liga Norte Riograndense Contra O Cancer	Natal
Brazil	Hospital Ernesto Dornelles	Porto Alegre
Brazil	Irmandade Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)	Rio de Janeiro
Brazil	Ministerio da Saude - Instituto Nacional do Cancer	Rio de Janeiro
Brazil	Oncoclinicas Rio de Janeiro S A	Rio de Janeiro
Brazil	Universidade do Estado do Rio de Janeiro - UERJ	Rio de Janeiro
Brazil	Hospital Santa Isabel	Salvador
Brazil	Fundacao do ABC - Centro Universitario FMABC	Santo Andre
Brazil	Fundacao Antonio Prudente A C Camargo Cancer Center	Sao Paulo
Brazil	Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo	Sao Paulo
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo
Brazil	Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE	Sao Paulo
Brazil	Instituto de Ensino e Pesquisa São Lucas	Sao Paulo
Brazil	Irmandade Santa Casa de Misericordia de Sao Paulo	Sao Paulo
Brazil	Instituto D Or de Pesquisa e Ensino (IDOR)	São Paulo
Brazil	Núcleo de Pesquisa São Camilo	São Paulo
Brazil	IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado	Sorocaba
Brazil	Instituto do Cancer De Tres Lagoas	Tres Lagoas
Bulgaria	MHAT Deva Maria	Burgas
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	Complex Oncology Center - Plovdiv EOOD	Plovdiv
Bulgaria	Specialized Hospital for Active Treatment in Oncology EAD	Sofia
Bulgaria	SHATOD 'Dr. Marko Antonov Markov'	Varna
Bulgaria	Comprehensive Cancer Center	Vratsa
Canada	Southern Alberta Institute of Urology / Prostate Cancer Centre	Calgary	Alberta
Canada	McMaster Institute of Urology	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)	Kingston	Ontario
Canada	Centre de Recherche du CHUM	Montreal	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario
Canada	University Health Network UHN Princess Margaret Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency BCCA Vancouver Centre	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Centre	Victoria	British Columbia
China	Beijing Cancer Hospital of Peking University	Beijing
China	Beijing Friendship Hospital	Beijing
China	Beijing Hospital	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Sichuan Provincial Peoples Hospital	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	Southwest Hospital, The Third Military Medical University	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou
China	Guangzhou First Municipal People's Hospital	GuangZhou
China	Sun Yat-Sen Memorial Hospital Sun Yat-sen University	Guangzhou
China	Jiangsu Cancer Hospital	Nanjing
China	Nanjing Drum Tower Hospital	Nanjing
China	Drug clinical trial ethics committee of Ningbo First Hospital	Ningbo
China	Fudan University Shanghai Cancer Center	Shanghai
China	Huashan Hospital Fudan University	Shanghai
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	ShangHai
China	ShangHai Huadong Hospital	ShangHai
China	The Fifth People's Hospital of Shanghai, Fudan University	ShangHai
China	The First Affiliated Hospital of Soochow University	Suzhou
China	Tianjin Medical University Cancer Hospital	Tianjin
China	The Central Hospital of Wuhan	Wuhan
China	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan
China	Wuxi People s Hospital	Wuxi
China	The First Affiliated Hospital of Xian Jiaotong University	Xi'an
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Králove
Czechia	Krajská nemocnice Liberec	Liberec
Czechia	Uromedical Center s.r.o.	Olomouc
Czechia	Multiscan s.r.o.	Pardubice
Czechia	Fakultni nemocnice Plzen, Urologicka klinika	Plzen
Czechia	Urologicka klinika 1.LF UK a VFN	Praha 2
Czechia	Thomayerova nemocnice, Onkologicka klinika	Praha 4
Czechia	Uherskohradistska nemocnice a.s.	Uherske Hradiste
France	CHRU De Besancon	Besancon
France	Institut Bergonié	Bordeaux
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Leon Berard	Lyon
France	Institut Regional du Cancer de Montpellier Val d'Aurelle	Montpellier
France	Polyclinique de Gentilly	Nancy
France	Centre Antoine Lacassagne	Nice Cedex 2
France	Hopital Europeen Georges-Pompidou	Paris Cedex 15
France	Institut de Cancerologie de l Ouest ICO	Saint Herblain
France	HIA Begin	Saint Mande
France	Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre	Strasbourg Cedex
Germany	Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer	Braunschweig
Germany	Urologicum Duisburg	Duisburg
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Universitätsklinikum Otto-von-Guericke-Universität Magdeburg	Magdeburg
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Studienpraxis Urologie Drs. Feyerabend	Nuertingen
Hungary	Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály	Budapest
Hungary	Semmelweis Egyetem, Urológia Klinika	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz	Gyula
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz	Nyiregyhaza
Hungary	Uro-Clin Kft.	Pécs
Hungary	Szegedi Tudomanyegyetem	Szeged
Hungary	Szegedi Tudomanyegyetem	Szeged
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
Israel	Asaf Harofe Medical Center	Beer Yaakov
Israel	Rambam Health Care Campus	Haifa
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center Tel Hashomer	Ramat Gan
Italy	AUSL Romagna - Ospedale di Faenza	Faenza
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Oncologia Medica A - Ist Naz Tumori G Pascale	Napoli
Italy	Istituto Oncologico Veneto Iov Irccs Padova	Padova
Italy	Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma	Parma
Italy	Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica	Perugia
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Campus Bio Medico di Roma	Roma
Italy	Fondazione Policlinico Universitario A Gemelli IRCCS	Roma
Italy	Azienda Ospedaliera S. Maria Terni	Terni
Italy	A.O.U. Città della Salute e della Scienza	Torino
Italy	Ospedale Santa Chiara Trento	Trento
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	Hospital Sultan Ismail	Johor Bahru
Malaysia	Hospital Likas	Kota Kinabalu
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching
Mexico	iBiomed Research Unit	Aguascalientes
Mexico	Mexico Centre for Clinical Research, S.A. de C.V.	Ciudad de Mexico
Mexico	Consultorio de Especialidad en Urologia Privado	Durango
Mexico	Avix Investigacion Clinica S C	Monterrey
Mexico	Consultorio Privado	Zapopan
Netherlands	NKI-AVL, Amsterdam	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	MC Haaglanden Lok Antoniushove - Afd.Interne - INT	Leidschendam
Netherlands	St. Antonius Ziekenhuis (St. Antonius Hospital)	Nieuwegein
Netherlands	Canisius-Wilhelminaziekenhuis	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Netherlands	Zuyderland Medical Center	Sittard-Geleen
Poland	Centrum Onkologii im. Prof. F. Lukaszczyka	Bydgoszcz
Poland	Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Szpitale Pomorskie Sp z o o	Gdynia
Poland	Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi	Lodz
Poland	Urologica Praktyka Lekarska Adam Marcheluk	Siedlce
Poland	Pomorski Uniwersytet Medyczny w Szczecinie	Szczecin
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy	Warszawa
Poland	Dolnoslaskie Centrum Onkologii	Wroclaw
Portugal	Hospitais da universidade de Coimbra	Coimbra
Portugal	Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE	Coimbra
Portugal	Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria	Lisboa
Portugal	Champalimaud Foundation Champalimaud Centre	Lisbon
Portugal	H. Santo António - Centro Hospitalar do Porto	Porto
Puerto Rico	VA Caribbean Healthcare System	San Juan
Russian Federation	Altai Regional Oncology Dispensary	Barnaul
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	GUZ Kursk Regional Oncology Dispensary	Kursk
Russian Federation	Moscow City Clinical Hospital # 62	Moscow
Russian Federation	Russian Scientific Center of Roentgenoradiology	Moscow
Russian Federation	Clinical Diagnostic Centre of Nizhny Novgorod Region	Nizhny Novgorod
Russian Federation	Clinical Oncology Dispensary	Omsk
Russian Federation	LLC Novaya Clinica	Pyatigorsk
Russian Federation	Pyatigorsk Interdistrict Oncology Dispensary	Pyatigorsk
Russian Federation	Private Medical Institution Euromedservice	Saint Petersburg
Russian Federation	Leningrad Regional Oncology Dispensary	Saint-Petersburg
Russian Federation	Russian Scientific Center of Radiology and Surgical Technologies	Sankt-Peterburg
Russian Federation	Republican Oncology Dispensary	Saransk
Russian Federation	Oncologic Dispensary No.2	Sochi
Russian Federation	Tambov Regional Oncology Clinical Dispansary	Tambov
Russian Federation	Tomsk Cancer Research Institute	Tomsk
Russian Federation	Medical-sanitary unit 'Neftyanik'	Tyumen
Russian Federation	Vologda Regional Oncological Dispensary	Vologda
South Africa	Clinresco Centres Pty Ltd	Johannesburg
South Africa	Clinical Research Unit	Pretoria
Spain	Hosp. Clinic de Barcelona	Barcelona
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. Del Mar	Barcelona
Spain	Hospital Juan Canalejo	Coruña
Spain	Hosp. de Jerez de La Frontera	Jerez de la Frontera
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hosp. Univ. Ramon Y Cajal	Madrid
Spain	Hosp. Virgen de La Victoria	Málaga
Spain	Hosp. Quiron Madrid Pozuelo	Pozuelo de Alarcon
Spain	Corporacio Sanitari Parc Tauli	Sabadell
Spain	Hosp. Univ. Marques de Valdecilla	Santander
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm
Sweden	Södersjukhuset	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Tungs' Taichung MetroHarbor Hospital	Taichung
Taiwan	Chi Mei Medical Center Yong Kang	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Turkey	Cukurova University, Faculty of Medicine	Adana
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Bakirkoy Training and Research Hospital	Istanbul
Turkey	Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	IEU Medical Point Hospital	Izmir
Turkey	Kocaeli University Medical Faculty	Kocaeli
Ukraine	Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'	Cherkasy
Ukraine	Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc	Dnipo
Ukraine	Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4	Dnipro
Ukraine	Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council	Dnipro
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk
Ukraine	Municipal non-profit enterprise 'Regional Center of Oncology'	Khakhiv
Ukraine	Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval	Kharkiv
Ukraine	State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center	Kyiv
Ukraine	State Institution National Cancer Institute	Kyiv
Ukraine	Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'	Lviv
Ukraine	ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'	Poltava
Ukraine	Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal	Uzhgorod
United Kingdom	Royal Blackburn Hospital	Blackburn
United Kingdom	Royal Lancaster Infirmary	Lancaster
United Kingdom	UCL Cancer Institute	London
United Kingdom	Torbay Hospital-Devon	Torquay
United Kingdom	Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital	Truro
United Kingdom	New Cross Hospital	Wolverhampton
United States	New York Oncology Hematology	Albany	New York
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	Rcca Md, Llc	Bethesda	Maryland
United States	Massachusetts General	Boston	Massachusetts
United States	Advanced Urology Institute	Daytona Beach	Florida
United States	The Urology Center of Colorado	Denver	Colorado
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Veterans Affairs Medical Ctr	Hines	Illinois
United States	Urology Centers Of Alabama	Homewood	Alabama
United States	Houston Metro Urology	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic - Division Of Hematology/oncology	Jacksonville	Florida
United States	University of Florida Health Jacksonville	Jacksonville	Florida
United States	First Urology	Jeffersonville	Indiana
United States	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Colorado Clinical Research	Lakewood	Colorado
United States	Lancaster Urology	Lancaster	Pennsylvania
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Arkansas Urology	Little Rock	Arkansas
United States	Norton Healthcare	Louisville	Kentucky
United States	Helios Clinical Research, LLC	Middleburg Heights	Ohio
United States	Delaware Valley Urology, LLC	Mount Laurel	New Jersey
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Adult Pediatric Urology & Urogynecology, P.C	Omaha	Nebraska
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	VA Pittsburgh	Pittsburgh	Pennsylvania
United States	Kaiser Permanente	Riverside	California
United States	Salem VA Medical Center	Salem	Virginia
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	San Bernardino Urological Associates	San Bernardino	California
United States	University of California San Francisco	San Francisco	California
United States	Sansum Clinic Pharm	Santa Barbara	California
United States	Oregon Urology Institute	Springfield	Oregon
United States	Upstate Cancer Center	Syracuse	New York
United States	NorthWest Medical Specialties, PLLC	Tacoma	Washington
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	Michigan Institute of Urology	Troy	Michigan
United States	Urological Associates of Southern Arizona, P.C.	Tucson	Arizona
United States	Urology of Virginia, PLCC	Virginia Beach	Virginia
United States	VA Connecticut Healthcare	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)	As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.	Up to 32 months
Secondary	Cohort 1: Overall Survival (OS)		Up to 97 months
Secondary	Cohort 1: Time to Symptomatic Progression		Up to 97 months
Secondary	Cohort 1: Time to Initiation of Cytotoxic Chemotherapy		Up to 97 months
Secondary	Observed Plasma Concentrations of Niraparib		Up to 97 months
Secondary	Observed Plasma Concentrations of Abiraterone		Up to 97 months
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)		Up to 96 months
Secondary	Number of Participants With Treatment-Emergent Adverse Events by Severity		Up to 96 months
Secondary	Number of Participants With Abnormalities in Laboratory Values		Up to 96 months