A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
MAGNITUDE
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
4 other identifiers
interventional
765
29 countries
318
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2019
Longer than P75 for phase_3
318 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
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedStudy Start
First participant enrolled
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedResults Posted
Study results publicly available
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2027
ExpectedApril 13, 2026
April 1, 2026
2.7 years
November 19, 2018
September 8, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 occurred 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
Cohort 1 Breast Cancer Gene (BRCA) Subgroup: 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 occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. 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. Confirmatory scan \>=2 new lesions indicate progression; scan does not show \>=2 new lesions means no progression. If Week 8 scan \<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 Outcomes (8)
Cohort 1: Overall Survival (OS)
Up to 97 months
Cohort 1: Time to Symptomatic Progression
Up to 97 months
Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
Up to 97 months
Observed Plasma Concentrations of Niraparib
Up to 97 months
Observed Plasma Concentrations of Abiraterone
Up to 97 months
- +3 more secondary outcomes
Study Arms (3)
Cohort 1: Participants with mCRPC and HRR Gene Alteration
EXPERIMENTALParticipants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Cohort 2: Participants with mCRPC and No HRR Gene Alteration
EXPERIMENTALParticipants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.
Cohort 3 (Open-label): Participants with mCRPC
EXPERIMENTALParticipants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.
Interventions
Participants will receive niraparib 200 mg capsules or tablets once daily.
Participants will receive AA 1000 mg tablets once daily.
Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
Participants will receive prednisone 10 mg tablets daily.
Participants will receive matching placebo once daily.
Eligibility Criteria
You may qualify if:
- HRR gene alteration (as identified by the sponsor's required assays) as follows:
- Cohort 1: positive for HRR gene alteration
- Cohort 2: not positive for DRD (that is, HRR gene alteration)
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (318)
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
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Kaiser Permanente
Riverside, California, 92505, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
University of California San Francisco
San Francisco, California, 94158, United States
Sansum Clinic Pharm
Santa Barbara, California, 93105, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
VA Connecticut Healthcare
West Haven, Connecticut, 06516, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32209, United States
Mayo Clinic - Division Of Hematology/oncology
Jacksonville, Florida, 32224, United States
Veterans Affairs Medical Ctr
Hines, Illinois, 60141, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46825, United States
First Urology
Jeffersonville, Indiana, 47130, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Rcca Md, Llc
Bethesda, Maryland, 20817, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Massachusetts General
Boston, Massachusetts, 02114, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska, 68114, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Delaware Valley Urology, LLC
Mount Laurel, New Jersey, 08054, United States
New York Oncology Hematology
Albany, New York, 12208, United States
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Upstate Cancer Center
Syracuse, New York, 13210, United States
Helios Clinical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Lancaster Urology
Lancaster, Pennsylvania, 17604, United States
VA Pittsburgh
Pittsburgh, Pennsylvania, 15240, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Houston Metro Urology
Houston, Texas, 77027, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Salem VA Medical Center
Salem, Virginia, 80113, United States
Urology of Virginia, PLCC
Virginia Beach, Virginia, 23462, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Hospital Aleman
Buenos Aires, C1118AAT, Argentina
Centro Oncológico Korben
Buenos Aires, C1426AGE, Argentina
CEMIC Saavedra
Buenos Aires, C1431FWN, Argentina
Centro de Urologia (CDU)
Ciudad Automoma Buenos Aires, C1120AAT, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, B7600FZN, Argentina
Hospital Privado de Comunidad
Mar del Plata, B7602CBM, Argentina
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM, Argentina
Sanatorio Britanico de Rosario
Rosario, 2000, Argentina
Sanatorio Parque
Rosario, S2000SDV, Argentina
ARS Médica
San Salvador de Jujuy, Y4600AFW, Argentina
Royal Adelaide Hospital
Adelaide, 5000, Australia
Pindara Private Hospital
Benowa, 4217, Australia
Sunshine Coast University Hospital
Birtinya, 4575, Australia
Princess Alexandra Hospital
Brisbane, 4102, Australia
St Vincent s Hospital Sydney
Darlinghurst, 2010, Australia
Royal Hobart Hospital
Hobart, 7000, Australia
Macquarie University
Macquarie University, 2109, Australia
Eye Surgery Associates
Malvern, 3144, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Hollywood Private Hospital
Nedlands, 6009, Australia
Prince Of Wales Hospital
Randwick, 2031, Australia
Sydney Adventist Hospital
Wahroonga, 2076, Australia
Wollongong Private Hospital
Wollongong, 2500, Australia
OLV Ziekenhuis Aalst
Aalst, 9300, Belgium
ZAS Augustinus
Antwerp, 2610, Belgium
Grand Hopital de Charleroi, site Notre Dame
Charleroi, 6000, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, B-4000, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, 30130-090, Brazil
Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
Brasília, 7020-730, Brazil
CIONC Centro Integrado de Oncologia de Curitiba
Curitiba, 80810 050, Brazil
Pronutrir
Fortaleza, 60 810180, Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
Goiânia, 74605-070, Brazil
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
Ijuí, 98700-000, 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
Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
Maceió, 57052-765, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-093, 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
Hospital Santa Isabel
Salvador, 40050-410, Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870, 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
Hospital Alemao Oswaldo Cruz
São Paulo, 01421-000, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, 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
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 04502-001, Brazil
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba, 18030-005, Brazil
Instituto do Cancer De Tres Lagoas
Três Lagoas, 79601-001, Brazil
MHAT Deva Maria
Burgas, 8001, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004, Bulgaria
Specialized Hospital for Active Treatment in Oncology EAD
Sofia, 1756, Bulgaria
SHATOD 'Dr. Marko Antonov Markov'
Varna, 9010, Bulgaria
Comprehensive Cancer Center
Vratsa, 3001, Bulgaria
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, 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
Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
Kingston, Ontario, K7L 3N6, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G2M9, Canada
Centre de Recherche du CHUM
Montreal, Quebec, H2X 0A9, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking University First Hospital
Beijing, 100034, China
Beijing Friendship Hospital
Beijing, 100050, China
Beijing Cancer Hospital of Peking University
Beijing, 100142, China
Peking University Third Hospital
Beijing, 100191, China
Beijing Hospital
Beijing, 100730, China
Sichuan Provincial Peoples Hospital
Chengdu, 610072, China
Southwest Hospital, The Third Military Medical University
Chongqing, 400025, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou, 510120, China
Guangzhou First Municipal People's Hospital
Guangzhou, 510180, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Drug clinical trial ethics committee of Ningbo First Hospital
Ningbo, 315010, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200001, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Huashan Hospital Fudan University
Shanghai, 200040, China
ShangHai Huadong Hospital
Shanghai, 200040, China
The Fifth People's Hospital of Shanghai, Fudan University
Shanghai, 200240, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Medical University Cancer Hospital
Tianjin, 300060, China
The Central Hospital of Wuhan
Wuhan, 430014, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030, China
Wuxi People s Hospital
Wuxi, 214023, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Fakultni nemocnice Hradec Kralove
Hradec Králove, 500 05, Czechia
Krajská nemocnice Liberec
Liberec, 460 63, Czechia
Uromedical Center s.r.o.
Olomouc, 77900, Czechia
Multiscan s.r.o.
Pardubice, 53203, Czechia
Fakultni nemocnice Plzen, Urologicka klinika
Pilsen, 305 99, Czechia
Urologicka klinika 1 LF UK a VFN
Prague, 120 00, Czechia
Thomayerova nemocnice, Onkologicka klinika
Prague, 140 59, Czechia
Uherskohradistska nemocnice a.s.
Uherské Hradiště, 68668, Czechia
CHRU De Besancon
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Leon Berard
Lyon, 69008, France
Institut Regional du Cancer de Montpellier Val d'Aurelle
Montpellier, 34298, France
Polyclinique de Gentilly
Nancy, 54100, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital Europeen Georges-Pompidou
Paris, 75908, France
Institut de Cancerologie de l Ouest ICO
Saint-Herblain, 44805, France
HIA Begin
Saint-Mandé, 94163, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098, France
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig, 38126, Germany
Urologicum Duisburg
Duisburg, 47179, Germany
Universitätsklinikum des Saarlandes
Homburg, 66424, Germany
Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Studienpraxis Urologie Drs. Feyerabend
Nürtingen, 72622, Germany
Semmelweis Egyetem, Urológia Klinika
Budapest, 1082, Hungary
Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
Nyíregyháza, 4400, Hungary
Uro-Clin Kft.
Pécs, 7621, Hungary
Szegedi Tudomanyegyetem
Szeged, 6720, Hungary
Szegedi Tudomanyegyetem 1
Szeged, 6725, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700, Hungary
Asaf Harofe Medical Center
Beer Yaakov, 60930, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Sheba Medical Center Tel Hashomer
Ramat Gan, 52621, Israel
AUSL Romagna - Ospedale di Faenza
Faenza, 48018, Italy
Ospedale San Raffaele
Milan, 20132, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Oncologia Medica A - Ist Naz Tumori G Pascale
Naples, 80131, Italy
Istituto Oncologico Veneto Iov Irccs Padova
Padova, 35128, Italy
Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
Parma, 43126, Italy
Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
Perugia, 06132, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Campus Bio Medico di Roma
Roma, 128, Italy
Azienda Ospedaliera S. Maria Terni
Terni, 5100, Italy
A.O.U. Città della Salute e della Scienza
Torino, 10126, Italy
Ospedale Santa Chiara Trento
Trento, 38122, Italy
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
Hospital Likas
Kota Kinabalu, 88996, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
iBiomed Research Unit
Aguascalientes, 20010, Mexico
Consultorio de Especialidad en Urologia Privado
Durango, 34000, Mexico
Mexico Centre for Clinical Research, S.A. de C.V.
Mexico City, 03100, Mexico
Avix Investigacion Clinica S C
Monterrey, 64710, Mexico
Consultorio Privado
Zapopan, 45040, Mexico
Antoni van Leeuwenhoek
Amsterdam, 1066 CX, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
MC Haaglanden Lok Antoniushove - Afd.Interne - INT
Leidschendam, 2262 BA, Netherlands
St. Antonius Ziekenhuis (St. Antonius Hospital)
Nieuwegein, 3430EM, Netherlands
Canisius-Wilhelminaziekenhuis
Nijmegen, 6532 SZ, Netherlands
Erasmus MC
Rotterdam, 3075 EA, Netherlands
Zuyderland Medical Center
Sittard-Geleen, 6162 BG, Netherlands
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
Bydgoszcz, 85 094, Poland
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, 85 796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214, Poland
Szpitale Pomorskie Sp z o o
Gdynia, 81 519, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-509, Poland
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, 08-110, Poland
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 70 111, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, 53 413, Poland
Hospitais da universidade de Coimbra
Coimbra, 3000-075, Portugal
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra, 3000-075, Portugal
Champalimaud Foundation Champalimaud Centre
Lisbon, 1400-038, Portugal
Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
Lisbon, 1649-035, Portugal
H. Santo António - Centro Hospitalar do Porto
Porto, 4099-001, Portugal
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
Altai Regional Oncology Dispensary
Barnaul, 656045, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
GUZ Kursk Regional Oncology Dispensary
Kursk, 305524, Russia
Russian Scientific Center of Roentgenoradiology
Moscow, 117997, Russia
Moscow City Clinical Hospital # 62
Moscow, 125130, Russia
Clinical Diagnostic Centre of Nizhny Novgorod Region
Nizhny Novgorod, 603000, 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
Russian Scientific Center of Radiology and Surgical Technologies
Saint Petersburg, 197758, Russia
Republican Oncology Dispensary
Saransk, 430032, Russia
Oncologic Dispensary No.2
Sochi, 354057, Russia
Tambov Regional Oncology Clinical Dispansary
Tambov, 392013, Russia
Tomsk Cancer Research Institute
Tomsk, 634050, Russia
Medical-sanitary unit 'Neftyanik'
Tyumen, 625000, Russia
Vologda Regional Oncological Dispensary
Vologda, 160012, Russia
Clinresco Centres Pty Ltd
Johannesburg, 1619, South Africa
Clinical Research Unit
Pretoria, 0001, 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
Ajou University Hospital
Gyeonggi-do, 443-721, 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 Marys Hospital
Seoul, 06591, South Korea
Hospital Juan Canalejo
A Coruña, 15006, Spain
Hosp. Del Mar
Barcelona, 08003, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 08208, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Sodersjukhuset
Stockholm, 11883, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 403, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung, 435, Taiwan
Chi Mei Medical Center Yong Kang
Tainan, 710, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 33305, Taiwan
Cukurova University, Faculty of Medicine
Adana, 01330, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 6560, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, 07070, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
IEU Medical Point Hospital
Izmir, 35575, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
Cherkasy, 18009, Ukraine
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
Dnipo, 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
Municipal non-profit enterprise 'Regional Center of Oncology'
Khakhiv, 61070, Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
Kharkiv, 61037, 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
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010, Ukraine
ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
Poltava, 36024, Ukraine
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
Uzhhorod, 88000, Ukraine
Royal Blackburn Hospital
Blackburn, BB2 3HH, United Kingdom
Royal Lancaster Infirmary
Lancaster, LA1 4RP, United Kingdom
UCL Cancer Institute
London, WC1E 6DD, United Kingdom
Torbay Hospital-Devon
Torquay, TQ2 7AA, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (4)
Rathkopf DE, Roubaud G, Chi KN, Efstathiou E, Attard G, Olmos D, Small EJ, Saad M, Castro E, Kim W, Wu D, Bertzos K, Dibaj S, Zhang J, Francis P, Smith MR. Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial. Eur Urol. 2025 Oct;88(4):359-369. doi: 10.1016/j.eururo.2024.09.003. Epub 2024 Sep 23.
PMID: 39317633DERIVEDRoubaud G, Attard G, Boegemann M, Olmos D, Trevisan M, Antoni L, Pascoe K, Capone C, Van Sanden S, Hashim M, Palmer S, Chi K. Adjustment for imbalances in baseline characteristics in the MAGNITUDE phase 3 study confirms the clinical benefit of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic prostate cancer. Eur J Cancer. 2024 Sep;209:114183. doi: 10.1016/j.ejca.2024.114183. Epub 2024 Jun 17.
PMID: 39111209DERIVEDDe Santis M, Breijo SM, Robinson P, Capone C, Pascoe K, Van Sanden S, Hashim M, Trevisan M, Daly C, Reitsma F, van Beekhuizen S, Ruan H, Heeg B, Verzoni E. Feasibility of Indirect Treatment Comparisons Between Niraparib Plus Abiraterone Acetate and Other First-Line Poly ADP-Ribose Polymerase Inhibitor Treatment Regimens for Patients with BRCA1/2 Mutation-Positive Metastatic Castration-Resistant Prostate Cancer. Adv Ther. 2024 Aug;41(8):3039-3058. doi: 10.1007/s12325-024-02918-6. Epub 2024 Jul 3.
PMID: 38958846DERIVEDChi KN, Rathkopf D, Smith MR, Efstathiou E, Attard G, Olmos D, Lee JY, Small EJ, Pereira de Santana Gomes AJ, Roubaud G, Saad M, Zurawski B, Sakalo V, Mason GE, Francis P, Wang G, Wu D, Diorio B, Lopez-Gitlitz A, Sandhu S; MAGNITUDE Principal Investigators. Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2023 Jun 20;41(18):3339-3351. doi: 10.1200/JCO.22.01649. Epub 2023 Mar 23.
PMID: 36952634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Executive Medical Director Oncology
- Organization
- Janssen Research & 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 21, 2018
Study Start
January 25, 2019
Primary Completion
October 8, 2021
Study Completion (Estimated)
February 27, 2027
Last Updated
April 13, 2026
Results First Posted
October 4, 2023
Record last verified: 2026-04