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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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