AzTrials
AzTrials

Castration-Resistant Prostatic CancerPhase 3MAGNITUDENCT03748641

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

A Phase 3 study testing Niraparib, Abiraterone Acetate and Prednisone in people with Castration-Resistant Prostatic Cancer, run by Janssen Research & Development, LLC at 318 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-Resistant Prostatic Cancer
What is being tested?
Niraparib, Abiraterone Acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
765 participants
Where
318 sitesin 29 countries
Study dates
25 Jan 2019to 31 Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

318 sites in 29 countries.

318 sites in 29 countries

United States47 sites

  • New York Oncology Hematology

    Albany, New York, 12208

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744

  • Rcca Md, Llc

    Bethesda, Maryland, 20817

  • Massachusetts General

    Boston, Massachusetts, 02114

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46825

  • Veterans Affairs Medical Ctr

    Hines, Illinois, 60141

  • Urology Centers Of Alabama

    Homewood, Alabama, 35209

  • Houston Metro Urology

    Houston, Texas, 77027

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • Mayo Clinic - Division Of Hematology/oncology

    Jacksonville, Florida, 32224

  • First Urology

    Jeffersonville, Indiana, 47130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

  • Lancaster Urology

    Lancaster, Pennsylvania, 17604

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Norton Healthcare

    Louisville, Kentucky, 40202

  • Helios Clinical Research, LLC

    Middleburg Heights, Ohio, 44130

  • Delaware Valley Urology, LLC

    Mount Laurel, New Jersey, 08054

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates

    Nashville, Tennessee, 37209

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Adult Pediatric Urology & Urogynecology, P.C

    Omaha, Nebraska, 68114

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • VA Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • Kaiser Permanente

    Riverside, California, 92505

  • Salem VA Medical Center

    Salem, Virginia, 80113

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • San Bernardino Urological Associates

    San Bernardino, California, 92404

  • University of California San Francisco

    San Francisco, California, 94158

  • Sansum Clinic Pharm

    Santa Barbara, California, 93105

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Upstate Cancer Center

    Syracuse, New York, 13210

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741

  • Urology of Virginia, PLCC

    Virginia Beach, Virginia, 23462

  • VA Connecticut Healthcare

    West Haven, Connecticut, 06516

Other trials in United States

Brazil29 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • PERSONAL Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130-090

  • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

    Brasília, 7020-730

  • CIONC Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810 050

  • Pronutrir

    Fortaleza, 60 810180

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

    Goiânia, 74605-070

  • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

    Ijuí, 98700-000

  • Fundacao Sao Francisco Xavier

    Ipatinga, 35162 189

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

    Joinville, 89201-260

  • Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.

    Maceió, 57052-765

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-093

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20230 130

  • Universidade do Estado do Rio de Janeiro - UERJ

    Rio de Janeiro, 20551-030

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905

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

    Rio de Janeiro, 22775 001

  • Hospital Santa Isabel

    Salvador, 40050-410

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650

  • Irmandade Santa Casa de Misericordia de Sao Paulo

    São Paulo, 01221-020

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, 01236-030

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

    São Paulo, 01246 000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01421-000

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 04502-001

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

    Sorocaba, 18030-005

  • Instituto Do Cancer Brasil

    Três Lagoas, 79601-001

Other trials in Brazil

China26 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Friendship Hospital

    Beijing, 100050

  • Beijing Cancer Hospital of Peking University

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Hospital

    Beijing, 100730

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072

  • Southwest Hospital, The Third Military Medical University

    Chongqing, 400025

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Sun Yat-Sen Memorial Hospital Sun Yat-sen University

    Guangzhou, 510120

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Drug clinical trial ethics committee of Ningbo First Hospital

    Ningbo, 315010

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200001

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • ShangHai Huadong Hospital

    Shanghai, 200040

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

    Shanghai, 200240

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Tianjin Medical University Cancer Hospital

    Tianjin, 300060

  • The Central Hospital of Wuhan

    Wuhan, 430014

  • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030

  • Wuxi People s Hospital

    Wuxi, 214023

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

Other trials in China

Russia18 sites

  • Altai Regional Oncology Dispensary

    Barnaul, 656045

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • GUZ Kursk Regional Oncology Dispensary

    Kursk, 305524

  • Russian Scientific Center of Roentgenoradiology

    Moscow, 117997

  • Moscow City Clinical Hospital # 62

    Moscow, 125130

  • Clinical Diagnostic Centre of Nizhny Novgorod Region

    Nizhny Novgorod, 603000

  • Clinical Oncology Dispensary

    Omsk, 644013

  • LLC Novaya Clinica

    Pyatigorsk, 357500

  • Pyatigorsk Interdistrict Oncology Dispensary

    Pyatigorsk, 357502

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, 191104

  • Private Medical Institution Euromedservice

    Saint Petersburg, 196603

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, 197758

  • Republican Oncology Dispensary

    Saransk, 430032

  • Oncologic Dispensary No.2

    Sochi, 354057

  • Tambov Regional Oncology Clinical Dispansary

    Tambov, 392013

  • Tomsk Cancer Research Institute

    Tomsk, 634050

  • Medical-sanitary unit 'Neftyanik'

    Tyumen, 625000

  • Vologda Regional Oncological Dispensary

    Vologda, 160012

Other trials in Russia

Australia14 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Pindara Private Hospital

    Benowa, 4217

  • Sunshine Coast University Hospital

    Birtinya, 4575

  • Princess Alexandra Hospital

    Brisbane, 4102

  • St Vincent s Hospital Sydney

    Darlinghurst, 2010

  • Royal Hobart Hospital

    Hobart, 7000

  • Macquarie University

    Macquarie University, 2109

  • Eye Surgery Associates

    Malvern, 3144

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Hollywood Private Hospital

    Nedlands, 6009

  • Prince Of Wales Hospital

    Randwick, 2031

  • Sydney Adventist Hospital

    Wahroonga, 2076

  • Wollongong Private Hospital

    Wollongong, 2500

Other trials in Australia

South Korea14 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hospital

    Gwangju, 61469

  • National Cancer Center

    Gyeonggi-do, 10408

  • Ajou University Hospital

    Gyeonggi-do, 443-721

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Italy13 sites

  • AUSL Romagna - Ospedale di Faenza

    Faenza, 48018

  • Ospedale San Raffaele

    Milan, 20132

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Oncologia Medica A - Ist Naz Tumori G Pascale

    Naples, 80131

  • Istituto Oncologico Veneto Iov Irccs Padova

    Padova, 35128

  • Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma

    Parma, 43126

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

    Perugia, 06132

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • Campus Bio Medico di Roma

    Roma, 128

  • Azienda Ospedaliera S. Maria Terni

    Terni, 5100

  • A.O.U. Città della Salute e della Scienza

    Torino, 10126

  • Ospedale Santa Chiara Trento

    Trento, 38122

Other trials in Italy

Argentina12 sites

  • Hospital Aleman

    Buenos Aires, C1118AAT

  • Centro Oncológico Korben

    Buenos Aires, C1426AGE

  • CEMIC Saavedra

    Buenos Aires, C1431FWN

  • Centro de Urologia (CDU)

    Ciudad Automoma Buenos Aires, C1120AAT

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, B7600FZN

  • Hospital Privado de Comunidad

    Mar del Plata, B7602CBM

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • Sanatorio Britanico de Rosario

    Rosario, 2000

  • Sanatorio Parque

    Rosario, S2000SDV

  • ARS Médica

    San Salvador de Jujuy, Y4600AFW

Other trials in Argentina

Spain12 sites

  • Hospital Juan Canalejo

    A Coruña, 15006

  • Hosp. Del Mar

    Barcelona, 08003

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Ukraine12 sites

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

    Cherkasy, 18009

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

    Dnipo, 49005

  • Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

    Dnipro, 49100

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

    Dnipro, 49102

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • Municipal non-profit enterprise 'Regional Center of Oncology'

    Khakhiv, 61070

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

    Kharkiv, 61037

  • State Nonprofit Enterprise National Cancer Institute

    Kyiv, 03022

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

    Kyiv, 03115

  • University Hospital of SNA Danylo Halytsky LMNU

    Lviv, 79010

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

    Poltava, 36024

  • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

    Uzhhorod, 88000

Other trials in Ukraine

France11 sites

  • CHRU De Besancon

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33000

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Leon Berard

    Lyon, 69008

  • Institut Regional du Cancer de Montpellier Val d'Aurelle

    Montpellier, 34298

  • Polyclinique de Gentilly

    Nancy, 54100

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Europeen Georges-Pompidou

    Paris, 75908

  • Institut de Cancerologie de l Ouest ICO

    Saint-Herblain, 44805

  • HIA Begin

    Saint-Mandé, 94163

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

Other trials in France

Turkey (Türkiye)10 sites

  • Cukurova University, Faculty of Medicine

    Adana, 01330

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 6560

  • Akdeniz University Medical Faculty

    Antalya, 07070

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • IEU Medical Point Hospital

    Izmir, 35575

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Canada9 sites

  • Southern Alberta Institute of Urology / Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • McMaster Institute of Urology

    Hamilton, Ontario, L8N 4A6

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

    Kingston, Ontario, K7L 3N6

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0A9

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G2M9

  • British Columbia Cancer Agency BCCA Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Hungary9 sites

  • Semmelweis Egyetem, Urológia Klinika

    Budapest, 1082

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

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

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

    Nyíregyháza, 4400

  • Uro-Clin Kft.

    Pécs, 7621

  • Szegedi Tudomanyegyetem

    Szeged, 6720

  • Szegedi Tudomanyegyetem 1

    Szeged, 6725

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

Other trials in Hungary

Poland9 sites

  • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

    Bydgoszcz, 85 094

  • Centrum Onkologii im Prof F Lukaszczyka

    Bydgoszcz, 85 796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

    Lodz, 93-509

  • Urologica Praktyka Lekarska Adam Marcheluk

    Siedlce, 08-110

  • Pomorski Uniwersytet Medyczny w Szczecinie

    Szczecin, 70 111

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53 413

Other trials in Poland

Czechia8 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králove, 500 05

  • Krajská nemocnice Liberec

    Liberec, 460 63

  • Uromedical Center s.r.o.

    Olomouc, 77900

  • Multiscan s.r.o.

    Pardubice, 53203

  • Fakultni nemocnice Plzen, Urologicka klinika

    Pilsen, 305 99

  • Urologicka klinika 1 LF UK a VFN

    Prague, 120 00

  • Thomayerova nemocnice, Onkologicka klinika

    Prague, 140 59

  • Uherskohradistska nemocnice a.s.

    Uherské Hradiště, 68668

Other trials in Czechia

Taiwan8 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 403

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435

  • Chi Mei Medical Center Yong Kang

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

Netherlands7 sites

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • MC Haaglanden Lok Antoniushove - Afd.Interne - INT

    Leidschendam, 2262 BA

  • St. Antonius Ziekenhuis (St. Antonius Hospital)

    Nieuwegein, 3430EM

  • Canisius-Wilhelminaziekenhuis

    Nijmegen, 6532 SZ

  • Erasmus MC

    Rotterdam, 3075 EA

  • Zuyderland Medical Center

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Belgium6 sites

  • OLV Ziekenhuis Aalst

    Aalst, 9300

  • ZAS Augustinus

    Antwerp, 2610

  • Grand Hopital de Charleroi, site Notre Dame

    Charleroi, 6000

  • AZ Maria Middelares

    Ghent, 9000

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, B-4000

  • ZNA Jan Palfijn

    Merksem, 2170

Other trials in Belgium

Bulgaria6 sites

  • MHAT Deva Maria

    Burgas, 8001

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004

  • Specialized Hospital for Active Treatment in Oncology EAD

    Sofia, 1756

  • SHATOD 'Dr. Marko Antonov Markov'

    Varna, 9010

  • Comprehensive Cancer Center

    Vratsa, 3001

Other trials in Bulgaria

Germany6 sites

  • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

    Braunschweig, 38126

  • Urologicum Duisburg

    Duisburg, 47179

  • Universitätsklinikum des Saarlandes

    Homburg, 66424

  • Universitätsklinikum Otto-von-Guericke-Universität Magdeburg

    Magdeburg, 39120

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Studienpraxis Urologie Drs. Feyerabend

    Nürtingen, 72622

Other trials in Germany

Malaysia6 sites

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • Hospital Likas

    Kota Kinabalu, 88996

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Sarawak General Hospital

    Kuching, 93586

Other trials in Malaysia

United Kingdom6 sites

  • Royal Blackburn Hospital

    Blackburn, BB2 3HH

  • Royal Lancaster Infirmary

    Lancaster, LA1 4RP

  • UCL Cancer Institute

    London, WC1E 6DD

  • Torbay Hospital-Devon

    Torquay, TQ2 7AA

  • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

    Truro, TR1 3LJ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Mexico5 sites

  • iBiomed Research Unit

    Aguascalientes, 20010

  • Consultorio de Especialidad en Urologia Privado

    Durango, 34000

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

    Mexico City, 03100

  • Avix Investigacion Clinica S C

    Monterrey, 64710

  • Consultorio Privado

    Zapopan, 45040

Other trials in Mexico

Portugal5 sites

  • Hospitais da universidade de Coimbra

    Coimbra, 3000-075

  • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

    Coimbra, 3000-075

  • Champalimaud Foundation Champalimaud Centre

    Lisbon, 1400-038

  • Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria

    Lisbon, 1649-035

  • H. Santo António - Centro Hospitalar do Porto

    Porto, 4099-001

Other trials in Portugal

Israel4 sites

  • Asaf Harofe Medical Center

    Beer Yaakov, 60930

  • Rambam Health Care Campus

    Haifa, 31096

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center Tel Hashomer

    Ramat Gan, 52621

Other trials in Israel

Sweden3 sites

  • Sodersjukhuset

    Stockholm, 11883

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

  • Akademiska Sjukhuset

    Uppsala, 751 85

Other trials in Sweden

South Africa2 sites

  • Clinresco Centres Pty Ltd

    Johannesburg, 1619

  • Clinical Research Unit

    Pretoria, 0001

Other trials in South Africa

Puerto Rico1 site

  • VA Caribbean Healthcare System

    San Juan, 00921

Other trials in Puerto Rico

About this study

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

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.

Being tested
Niraparib, Abiraterone Acetate, Prednisone, Placebo, New Formulation of Niraparib and Abiraterone Acetate (AA)
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called JNJ-64091742

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

  • Abiraterone AcetateDrug

    Participants will receive AA 1000 mg tablets once daily.

  • PrednisoneDrug

    Participants will receive prednisone 10 mg tablets daily.

  • PlaceboDrug

    Participants will receive matching placebo once daily.

  • New Formulation of Niraparib and Abiraterone Acetate (AA)Drug

    Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.

Study groups in NCT03748641
Study groupRoleWhat they receive
Cohort 1: Participants with mCRPC and HRR Gene AlterationExperimentalParticipants 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.
Receives: Drug: Niraparib; Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Placebo
Cohort 2: Participants with mCRPC and No HRR Gene AlterationExperimentalParticipants 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.
Receives: Drug: Niraparib; Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Placebo
Cohort 3 (Open-label): Participants with mCRPCExperimentalParticipants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.
Receives: Drug: Prednisone; Drug: New Formulation of Niraparib and Abiraterone Acetate (AA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 32 months

  2. 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.

    Measured: Up to 32 months

Secondary outcomes (8)

  1. Cohort 1: Overall Survival (OS)

    Measured: Up to 97 months

  2. Cohort 1: Time to Symptomatic Progression

    Measured: Up to 97 months

  3. Cohort 1: Time to Initiation of Cytotoxic Chemotherapy

    Measured: Up to 97 months

  4. Observed Plasma Concentrations of Niraparib

    Measured: Up to 97 months

  5. Observed Plasma Concentrations of Abiraterone

    Measured: Up to 97 months

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to 96 months

  7. Number of Participants With Treatment-Emergent Adverse Events by Severity

    Measured: Up to 96 months

  8. Number of Participants With Abnormalities in Laboratory Values

    Measured: Up to 96 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2018
  2. Study start25 Jan 2019
  3. Primary completion8 Oct 2021
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
765 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748641
Sponsor's protocol ID
CR108534
Other IDs
64091742PCR3001, 2017-003364-12, 2023-503254-12-00, 2023, 2017
Acronym
MAGNITUDE
Status last verified
Nov 2026
First submitted
19 Nov 2018
Last updated
3 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ye D, Saad M, Lee JY, Jung W, Pang ST, Li L, Gurney H, Attard G, Chi KN, Mundle S, Zhuo J, Singh A, Lin Y, Sandhu S. Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study. Int J Urol. 2026 Apr;33(4):e70455. doi: 10.1111/iju.70455.

    PubMed 42015879

  • Russu A, Hazra A, Tian H, Haddish-Berhane N, Perez Ruixo JJ, Boulton M. Population Pharmacokinetics of Niraparib/Abiraterone Acetate Administered as Single-Agent Combination and Dual-Acting Tablets Plus Prednisone for Metastatic Castration-Resistant Prostate Cancer. Adv Ther. 2025 Apr;42(4):1860-1880. doi: 10.1007/s12325-025-03104-y. Epub 2025 Feb 28.

    PubMed 40016438

  • 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.

    PubMed 39317633

  • Roubaud 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.

    PubMed 39111209

  • De 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.

    PubMed 38958846

  • Chi 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.

    PubMed 36952634

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niraparib, Abiraterone Acetate and Prednisone in people with Castration-Resistant Prostatic Cancer, run by Janssen Research & Development, LLC at 318 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 318 sites in United States, Brazil, China, Russia, Australia and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03748641, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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