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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

765

Participants

Timeline

Start Date

January 25, 2019

Primary Completion Date

October 8, 2021

Study Completion Date

February 27, 2027

Conditions
Castration-Resistant Prostatic Cancer
Interventions
DRUG

Niraparib

Participants will receive niraparib 200 mg capsules or tablets once daily.

DRUG

Abiraterone Acetate

Participants will receive AA 1000 mg tablets once daily.

DRUG

Prednisone

Participants will receive prednisone 10 mg tablets daily.

DRUG

Placebo

Participants will receive matching placebo once daily.

DRUG

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.

Trial Locations (318)

100

National Taiwan University Hospital, Taipei

128

Campus Bio Medico di Roma, Roma

403

China Medical University Hospital, Taichung

435

Tungs' Taichung MetroHarbor Hospital, Taichung

710

Chi Mei Medical Center Yong Kang, Tainan City

807

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

1082

Semmelweis Egyetem, Urológia Klinika, Budapest

1122

Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály, Budapest

1619

Clinresco Centres Pty Ltd, Johannesburg

1756

Specialized Hospital for Active Treatment in Oncology EAD, Sofia

2000

Sanatorio Britanico de Rosario, Rosario

2010

St Vincent s Hospital Sydney, Darlinghurst

2031

Prince Of Wales Hospital, Randwick

2076

Sydney Adventist Hospital, Wahroonga

2109

Macquarie University, Macquarie University

2170

ZNA Jan Palfijn, Merksem

2500

Wollongong Private Hospital, Wollongong

2610

ZAS Augustinus, Antwerp

3000

Peter MacCallum Cancer Centre, Melbourne

3001

Comprehensive Cancer Center, Vratsa

3144

Eye Surgery Associates, Malvern

4004

Complex Oncology Center - Plovdiv EOOD, Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4102

Princess Alexandra Hospital, Brisbane

4217

Pindara Private Hospital, Benowa

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Nyíregyháza

4575

Sunshine Coast University Hospital, Birtinya

5000

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Córdoba

Royal Adelaide Hospital, Adelaide

5100

Azienda Ospedaliera S. Maria Terni, Terni

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Gyula

5800

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

6000

Grand Hopital de Charleroi, site Notre Dame, Charleroi

6009

Hollywood Private Hospital, Nedlands

6150

Fiona Stanley Hospital, Murdoch

6560

Ankara Bilkent Sehir Hastanesi, Ankara

6720

Szegedi Tudomanyegyetem, Szeged

6725

Szegedi Tudomanyegyetem, Szeged

7000

Royal Hobart Hospital, Hobart

7621

Uro-Clin Kft., Pécs

8001

MHAT Deva Maria, Burgas

9000

AZ Maria Middelares, Ghent

9010

SHATOD 'Dr. Marko Antonov Markov', Varna

9300

OLV Ziekenhuis Aalst, Aalst

9700

Markusovszky Egyetemi Oktatokorhaz, Szombathely

10029

Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10126

A.O.U. Città della Salute e della Scienza, Torino

10408

National Cancer Center, Gyeonggi-do

10990

Hospital Pulau Pinang, George Town

11217

Taipei Veterans General Hospital, Taipei

11407

Hosp. de Jerez de La Frontera, Jerez de la Frontera

11883

Sodersjukhuset, Stockholm

12208

New York Oncology Hematology, Albany

13210

Upstate Cancer Center, Syracuse

13620

Seoul National University Bundang Hospital, Seongnam-si

15006

Hospital Juan Canalejo, A Coruña

15240

VA Pittsburgh, Pittsburgh

17604

Lancaster Urology, Lancaster

18009

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

19004

MidLantic Urology, Bala-Cynwyd

20010

iBiomed Research Unit, Aguascalientes

20132

Ospedale San Raffaele, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20817

Rcca Md, Llc, Bethesda

21204

Chesapeake Urology Research Associates, Towson

22030

Trakya University Medical Faculty, Edirne

23462

Urology of Virginia, PLCC, Virginia Beach

25030

CHRU De Besancon, Besançon

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28040

Hosp. Clinico San Carlos, Madrid

28223

Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcón

29010

Hosp Virgen de La Victoria, Málaga

29572

Carolina Urologic Research Center, Myrtle Beach

31096

Rambam Health Care Campus, Haifa

32114

Advanced Urology Institute, Daytona Beach

32209

University of Florida Health Jacksonville, Jacksonville

32224

Mayo Clinic - Division Of Hematology/oncology, Jacksonville

33000

Institut Bergonie, Bordeaux

33305

Chang Gung Memorial Hospital, Taoyuan District

33744

Bay Pines VA Healthcare System, Bay Pines

34000

Consultorio de Especialidad en Urologia Privado, Durango

34096

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34147

Bakirkoy Training and Research Hospital, Istanbul

34298

Institut Regional du Cancer de Montpellier Val d'Aurelle, Montpellier

34722

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul

35015

Chungnam National University Hospital, Daejeon

35128

Istituto Oncologico Veneto Iov Irccs Padova, Padua

35209

Urology Centers Of Alabama, Homewood

35575

IEU Medical Point Hospital, Izmir

36024

ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council', Poltava

37209

Urology Associates, Nashville

38122

Ospedale Santa Chiara Trento, Trento

38126

Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer, Braunschweig

39008

Hosp. Univ. Marques de Valdecilla, Santander

39120

Universitätsklinikum Otto-von-Guericke-Universität Magdeburg, Magdeburg

40202

Norton Healthcare, Louisville

40705

Taichung Veterans General Hospital, Taichung

41380

Kocaeli University Medical Faculty, Kocaeli

41404

Kyungpook National University Chilgok Hospital, Daegu

42601

Keimyung University Dongsan Hospital, Daegu

43126

Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma, Parma

44130

Helios Clinical Research, LLC, Middleburg Heights

44805

Institut de Cancerologie de l Ouest ICO, Saint-Herblain

45040

Consultorio Privado, Zapopan

46026

Hosp. Univ. I Politecni La Fe, Valencia

46825

Fort Wayne Medical Oncology and Hematology, Fort Wayne

47130

First Urology, Jeffersonville

47179

Urologicum Duisburg, Duisburg

48018

AUSL Romagna - Ospedale di Faenza, Faenza

48084

Michigan Institute of Urology, Troy

48149

Universitaetsklinikum Muenster, Münster

49005

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

49100

Rabin Medical Center, Petah Tikva

Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council, Dnipro

49102

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

49241

Pusan National University Hospital, Busan

50586

Hospital Kuala Lumpur, Kuala Lumpur

52621

Sheba Medical Center Tel Hashomer, Ramat Gan

53203

Multiscan s.r.o., Pardubice

54100

Polyclinique de Gentilly, Nancy

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

59100

University Malaya Medical Centre, Kuala Lumpur

60141

Veterans Affairs Medical Ctr, Hines

60930

Asaf Harofe Medical Center, Beer Yaakov

61037

Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval, Kharkiv

61070

Municipal non-profit enterprise 'Regional Center of Oncology', Khakhiv

61469

Chonnam National University Hospital, Gwangju

63011

Centre Jean Perrin, Clermont-Ferrand

64128

Kansas City Veterans Affairs Medical Center, Kansas City

64710

Avix Investigacion Clinica S C, Monterrey

66160

University of Kansas Medical Center, Kansas City

66424

Universitätsklinikum des Saarlandes, Homburg

67098

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre, Strasbourg

68114

Adult Pediatric Urology & Urogynecology, P.C, Omaha

68130

Nebraska Cancer Specialists, Omaha

68668

Uherskohradistska nemocnice a.s., Uherské Hradiště

69008

Centre Leon Berard, Lyon

70121

Ochsner Clinic Foundation, New Orleans

72211

Arkansas Urology, Little Rock

72622

Studienpraxis Urologie Drs. Feyerabend, Nürtingen

75908

Hopital Europeen Georges-Pompidou, Paris

76008

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

77027

Houston Metro Urology, Houston

77030

University of Texas MD Anderson Cancer Center, Houston

77900

Uromedical Center s.r.o., Olomouc

79010

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

80113

Salem VA Medical Center, Salem

80131

Oncologia Medica A - Ist Naz Tumori G Pascale, Napoli

80211

The Urology Center of Colorado, Denver

80228

Colorado Clinical Research, Lakewood

81100

Hospital Sultan Ismail, Johor Bahru

84106

Utah Cancer Specialists, Salt Lake City

85054

Mayo Clinic Arizona, Phoenix

85741

Urological Associates of Southern Arizona, P.C., Tucson

88000

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal, Uzhhorod

88996

Hospital Likas, Kota Kinabalu

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

92404

San Bernardino Urological Associates, San Bernardino

92505

Kaiser Permanente, Riverside

93105

Sansum Clinic Pharm, Santa Barbara

93586

Sarawak General Hospital, Kuching

94158

University of California San Francisco, San Francisco

94163

HIA Begin, Saint-Mandé

97477

Oregon Urology Institute, Springfield

98405

NorthWest Medical Specialties, PLLC, Tacoma

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100034

Peking University First Hospital, Beijing

100050

Beijing Friendship Hospital, Beijing

100142

Beijing Cancer Hospital of Peking University, Beijing

100191

Peking University Third Hospital, Beijing

100730

Beijing Hospital, Beijing

117997

Russian Scientific Center of Roentgenoradiology, Moscow

125130

Moscow City Clinical Hospital # 62, Moscow

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

160012

Vologda Regional Oncological Dispensary, Vologda

191104

Leningrad Regional Oncology Dispensary, Saint Petersburg

196603

Private Medical Institution Euromedservice, Saint Petersburg

197758

Russian Scientific Center of Radiology and Surgical Technologies, Saint Petersburg

200001

Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

200040

Huashan Hospital Fudan University, Shanghai

ShangHai Huadong Hospital, Shanghai

200240

The Fifth People's Hospital of Shanghai, Fudan University, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

210009

Jiangsu Cancer Hospital, Nanjing

214023

Wuxi People s Hospital, Wuxi

215006

The First Affiliated Hospital of Soochow University, Suzhou

300060

Tianjin Medical University Cancer Hospital, Tianjin

305524

GUZ Kursk Regional Oncology Dispensary, Kursk

315010

Drug clinical trial ethics committee of Ningbo First Hospital, Ningbo

350001

Fujian Medical University Union Hospital, Fuzhou

354057

Oncologic Dispensary No.2, Sochi

357500

LLC Novaya Clinica, Pyatigorsk

357502

Pyatigorsk Interdistrict Oncology Dispensary, Pyatigorsk

392013

Tambov Regional Oncology Clinical Dispansary, Tambov

400025

Southwest Hospital, The Third Military Medical University, Chongqing

400030

Chongqing University Cancer Hospital, Chongqing

430014

The Central Hospital of Wuhan, Wuhan

430030

Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology, Wuhan

430032

Republican Oncology Dispensary, Saransk

510120

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

510180

Guangzhou First Municipal People's Hospital, Guangzhou

603000

Clinical Diagnostic Centre of Nizhny Novgorod Region, Nizhny Novgorod

610072

Sichuan Provincial Peoples Hospital, Chengdu

625000

Medical-sanitary unit 'Neftyanik', Tyumen

634050

Tomsk Cancer Research Institute, Tomsk

644013

Clinical Oncology Dispensary, Omsk

656045

Altai Regional Oncology Dispensary, Barnaul

710061

The First Affiliated Hospital of Xian Jiaotong University, Xi'an

06516

VA Connecticut Healthcare, West Haven

02114

Massachusetts General, Boston

08054

Delaware Valley Urology, LLC, Mount Laurel

C1118AAT

Hospital Aleman, Buenos Aires

C1426AGE

Centro Oncológico Korben, Buenos Aires

C1431FWN

CEMIC Saavedra, Buenos Aires

C1120AAT

Centro de Urologia (CDU), Ciudad Automoma Buenos Aires

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

B7600FZN

Instituto de Investigaciones Clinicas Mar del Plata, Mar del Plata

B7602CBM

Hospital Privado de Comunidad, Mar del Plata

B2700CPM

Centro de Investigacion Pergamino SA, Pergamino

S2000SDV

Sanatorio Parque, Rosario

Y4600AFW

ARS Médica, San Salvador de Jujuy

B-4000

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman, Liège

14784-400

Fundacao Pio XII, Barretos

30130-090

PERSONAL Oncologia de Precisao e Personalizada, Belo Horizonte

7020-730

Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia, Brasília

80810 050

CIONC Centro Integrado de Oncologia de Curitiba, Curitiba

60 810180

Pronutrir, Fortaleza

74605-070

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

98700-000

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda, Ijuí

35162 189

Fundacao Sao Francisco Xavier, Ipatinga

89201-260

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

57052-765

Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda., Maceió

59062 000

Liga Norte Riograndense Contra O Cancer, Natal

90020-090

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90160-093

Hospital Ernesto Dornelles, Porto Alegre

20230 130

Ministerio da Saude Instituto Nacional do Cancer, Rio de Janeiro

20551-030

Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro

22250 905

Oncoclinicas Rio de Janeiro S A, Rio de Janeiro

22775 001

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

40050-410

Hospital Santa Isabel, Salvador

09060 870

Fundacao do ABC Centro Universitario FMABC, Santo André

01221-020

Irmandade Santa Casa de Misericordia de Sao Paulo, São Paulo

01236-030

Instituto de Ensino e Pesquisa São Lucas, São Paulo

01246 000

Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo, São Paulo

01421-000

Hospital Alemao Oswaldo Cruz, São Paulo

01509 900

Fundacao Antonio Prudente A C Camargo Cancer Center, São Paulo

04014-002

Núcleo de Pesquisa São Camilo, São Paulo

04039-004

Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, São Paulo

04502-001

Instituto D Or de Pesquisa e Ensino IDOR, São Paulo

18030-005

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado, Sorocaba

79601-001

Instituto do Cancer De Tres Lagoas, Três Lagoas

T2V 1P9

Southern Alberta Institute of Urology / Prostate Cancer Centre, Calgary

V5Z 4E6

British Columbia Cancer Agency BCCA Vancouver Centre, Vancouver

V8R 6V5

British Columbia Cancer Agency Vancouver Island Centre, Victoria

L8N 4A6

McMaster Institute of Urology, Hamilton

K7L 3N6

Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre), Kingston

M4N 3M5

Sunnybrook Health Sciences Center, Toronto

M5G2M9

Princess Margaret Cancer Centre University Health Network, Toronto

H2X 0A9

Centre de Recherche du CHUM, Montreal

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králove

460 63

Krajská nemocnice Liberec, Liberec

305 99

Fakultni nemocnice Plzen, Urologicka klinika, Pilsen

120 00

Urologicka klinika 1 LF UK a VFN, Prague

140 59

Thomayerova nemocnice, Onkologicka klinika, Prague

06189

Centre Antoine Lacassagne, Nice

06132

Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica, Perugia

00168

Fondazione Policlinico Universitario A Gemelli IRCCS, Roma

03100

Mexico Centre for Clinical Research, S.A. de C.V., Mexico City

1066 CX

Antoni van Leeuwenhoek, Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

2262 BA

MC Haaglanden Lok Antoniushove - Afd.Interne - INT, Leidschendam

3430EM

St. Antonius Ziekenhuis (St. Antonius Hospital), Nieuwegein

6532 SZ

Canisius-Wilhelminaziekenhuis, Nijmegen

3075 EA

Erasmus MC, Rotterdam

6162 BG

Zuyderland Medical Center, Sittard-Geleen

85 094

Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza, Bydgoszcz

85 796

Centrum Onkologii im Prof F Lukaszczyka, Bydgoszcz

80 214

Uniwersyteckie Centrum Kliniczne, Gdansk

81 519

Szpitale Pomorskie Sp z o o, Gdynia

93-509

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz

08-110

Urologica Praktyka Lekarska Adam Marcheluk, Siedlce

70 111

Pomorski Uniwersytet Medyczny w Szczecinie, Szczecin

02-781

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warsaw

53 413

Dolnoslaskie Centrum Onkologii, Wroclaw

3000-075

Hospitais da universidade de Coimbra, Coimbra

Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE, Coimbra

1400-038

Champalimaud Foundation Champalimaud Centre, Lisbon

1649-035

Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria, Lisbon

4099-001

H. Santo António - Centro Hospitalar do Porto, Porto

00921

VA Caribbean Healthcare System, San Juan

0001

Clinical Research Unit, Pretoria

443-721

Ajou University Hospital, Gyeonggi-do

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08003

Hosp. Del Mar, Barcelona

08025

Hosp. de La Santa Creu I Sant Pau, Barcelona

08036

Hosp Clinic de Barcelona, Barcelona

08208

Corporacio Sanitari Parc Tauli, Sabadell

171 76

Karolinska Universitetssjukhuset Solna, Stockholm

751 85

Akademiska Sjukhuset, Uppsala

01330

Cukurova University, Faculty of Medicine, Adana

06200

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara

07070

Akdeniz University Medical Faculty, Antalya

03022

State Institution National Cancer Institute, Kyiv

03115

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

BB2 3HH

Royal Blackburn Hospital, Blackburn

LA1 4RP

Royal Lancaster Infirmary, Lancaster

WC1E 6DD

UCL Cancer Institute, London

TQ2 7AA

Torbay Hospital-Devon, Torquay

TR1 3LJ

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital, Truro

WV10 0QP

New Cross Hospital, Wolverhampton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY