Back to resultsA Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE)
Primary Purpose
Metastatic Castration-sensitive Prostate Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Niraparib
Abiraterone acetate (AA)
Prednisone
Placebo for Niraparib
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-sensitive Prostate Cancer
Eligibility Criteria
Inclusion criteria:
- Pathological diagnosis of prostate adenocarcinoma
- Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
- Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
- Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase
- Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation and 1 surgical intervention for symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal cord compression or obstructive symptoms). Participants with radiation or surgical interventions to all known sites of metastatic disease will be excluded from trial participation. Radiation must be completed prior to randomization (b) Up to a maximum of 6 months of ADT prior to randomization; (c) Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to randomization (d) Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to randomization
Exclusion criteria:
- Prior treatment with a poly (adenosine diphosphate-ribose) polymerase (inhibitor) (PARP) inhibitor
- History of adrenal dysfunction
- Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
- History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
Sites / Locations
- Urology Centers Of Alabama
- Mayo Clinic Arizona
- Urological Associates of Southern Arizona, P.C.
- Greater Los Angeles VA Healthcare System
- University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
- San Bernardino Urological Associates
- University of San Francisco California
- Rocky Mountain Cancer Centers
- The Urology Center of Colorado
- Colorado Clinical Research
- Eastern Connecticut Hematology & Oncology Assoc.
- Advanced Urology Institute
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
- University of Florida Health Jacksonville
- Cancer Specialists of North Florida
- Urology of Indiana
- First Urology
- Ochsner Clinic Foundation
- Baltimore VA Medical Center
- Maryland Oncology Hematology, PA
- Chesapeake Urology Associates
- Michigan Institute of Urology
- Mosaic Life Care
- St. Louis VA Medical Center
- GU Research Network
- New York Oncology Hematology
- Montefiore Medical Center
- Manhattan VAMC
- Mount Sinai
- Memorial Sloan Kettering Cancer Center
- Associated Medical Professionals
- Durham VAMC
- Stephenson Cancer Center
- VA Portland Health Care System
- Oregon Oncology Specialists
- Keystone Urology Specialists
- Philadelphia VA Medical Center
- University of Pennsylvania
- University of Pittsburgh Medical Center (UPMC)
- Ralph H. Johnson Veterans Affairs Medical Center
- Prisma Health
- Urology Associates
- Texas Oncology-Austin
- Texas Oncology-Denton South
- Houston Metro Urology
- Texas Oncology P.A.
- Texas Oncology-Tyler
- University of Utah Huntsman Cancer Institute
- Virginia Oncology Associates
- Virginia Commonwealth University - Massey Cancer Center
- VA Puget Sound Healthcare System
- Seattle Cancer Care Alliance
- MultiCare Health System
- Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
- Centro Oncológico Korben
- Hospital Militar Cosme Argerich
- CINME - Centro de Investigaciones Metabolicas
- CIPREC Arenales
- Centro de Urologia (CDU)
- Hospital Italiano de Buenos Aires
- Clínica Adventista Belgrano
- Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
- Centro Urologico Profesor Bengio
- Instituto Médico de Río Cuarto
- Hospital Privado de Cordoba
- Hospital Privado de Comunidad
- Centro de Investigacion Pergamino SA
- ARS Médica
- Sunshine Coast University Hospital
- St. Vincent's Hospital Sydney
- Royal Brisbane and Women's Hospital
- Royal Hobart Hospital
- Ashford Cancer Centre
- Liverpool Hospital
- Peter MacCallum Cancer Centre
- Fiona Stanley Hospital
- Macquarie University Hospital
- ICON Cancer Care
- St John of God Subiaco Hospital
- Bobruisk Interregional Oncological Dispensary
- Brest Regional Oncology Dispensary
- Gomel Regional Clinical Oncology Dispensary
- Grodno University Hospital
- State Institution N.N. Alexandrov Republican Scientific and
- Minsk city Clinical Oncological Dispensary
- Mogilev Regional Hospital
- Vitebsk Regional Clinical Hospital
- ZNA Middelheim
- Grand Hopital de Charleroi, site Notre Dame
- Jolimont
- CHC MontLegia
- CHU UCL Namur - Site Sainte Elisabeth
- Clinique St Pierre
- Algemeen Ziekenhuis Delta
- GZA Ziekenhuizen
- Fundacao Pio XII
- Cetus Oncologia
- PERSONAL - Oncologia de Precisão e Personalizada
- CIONC - Centro Integrado de Oncologia de Curitiba
- Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
- Pronutrir
- Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
- Fundação São Francisco Xavier
- Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
- Liga Norte Riograndense Contra O Cancer
- UPCO Unidade de Pesquisa Clinica em Oncologia
- Irmandade Santa Casa de Misericordia de Porto Alegre
- Hospital Ernesto Dornelles
- MultiHemo Servicos Medicos S.A
- Ministerio da Saude - Instituto Nacional do Cancer
- Universidade do Estado do Rio de Janeiro - UERJ
- Oncoclínicas Rio de Janeiro S.A.
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
- Nucleo de Oncologia da Bahia
- Hospital Sao Rafael
- Fundacao do ABC - Centro Universitario FMABC
- Irmandade Santa Casa de Misericordia de Sao Paulo
- Instituto de Ensino e Pesquisa São Lucas
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
- Hospital Alemao Oswaldo Cruz
- Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
- IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
- Instituto do Cancer Arnaldo Vieira de Carvalho
- Real e Benemérita Associação Portuguesa de Beneficência
- Núcleo de Pesquisa São Camilo
- Centro Oncológico do Triângulo
- MHAT Deva Maria
- UMHAT 'Dr. Georgi Stranski', EAD
- District Oncology Dispensary with In-Patient Stationary - Plovdiv
- Multifunctional Hospital for Active Treatment for Women Health Nadezhda
- Specialized Hospital for Active Treatment in Oncology
- UMHAT Sofia Med
- Comprehensive Cancer Center
- Prostate Cancer Centre
- Cross Cancer Institute
- British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
- British Columbia Cancer Agency (BCCA) - Vancouver Centre
- British Columbia Cancer Agency - Vancouver Island Centre
- McMaster Institute of Urology
- Kingston Health Sciences Centre, Kingston General Health Research Institute
- Sunnybrook Health Sciences Center
- University Health Network (UHN) Princess Margaret Cancer Centre
- Centre Hospitalier de l'Universite de Montreal
- McGill University - Jewish General Hospital
- Cancer Hospital Chinese Academy of Medical Sciences
- Peking University First Hospital
- Beijing Friendship Hospital, Capital Medical University
- Beijing Cancer Hospital
- Beijing University Third Hospital
- Beijing Hospital
- West China Hospital of Sichuan University
- Sichuan Provincial People's Hospital
- Western Theater General Hospital of the Chinese People's Liberation Army
- Chongqing University Cancer Hospital
- Southwest Hospital, The Third Military Medical University
- Sun Yat-Sen University Cancer Center
- Guangzhou First Municipal People's Hospital
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
- Zhejiang Provincial People's Hospital
- The First Affiliated Hospital of NanChang University
- Jiangsu Province Cancer Hospital
- Nanjing Drum Tower Hospital
- The First Affiliated Hospital of Ningbo University
- Fudan University Shanghai Cancer Center
- Huashan Hospital Fudan University
- Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
- The Fifth People's Hospital of Shanghai, Fudan University
- Huadong Hospital Affiliated to Fudan University
- Shengjing Hospital of China Medical University
- Second Affiliated Hospital of Soochow University
- The First Affliated Hospital of Soochow University
- The First Affiliated Hospital of Wenzhou Medical University
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
- The First Affiliated Hospital of Xi'an Jiaotong University
- Fakultni nemocnice u sv. Anny v Brne
- FN Hradec Kralove, Urologicka klinika
- Krajská nemocnice Liberec
- Uromedical Center s.r.o.
- Urologicka klinika 1.LF UK a VFN
- Aalborg University Hospital
- Copenhagen University Hospital
- Herlev Hospital
- Næstved Hospital
- Odense Universitetshospital
- Vejle Hospital
- Institut de Cancérologie de l'Ouest (ICO)
- Institut Sainte Catherine
- CHRU De Besancon
- Institut Bergonié
- Centre Jean Perrin
- Centre Georges François Leclerc
- Centre Oscar Lambret
- Centre Leon Bérard
- Hopital Prive Jean Mermoz
- Institut Regional du Cancer de Montpellier Val d'Aurelle
- Polyclinique de Gentilly
- CHU De Poitiers
- Centre Hopitalier Inter-Communal De Cornouaille
- HIA Begin
- Institut de Cancérologie de Loire
- Clinique Sainte Anne
- Hopital Foch
- CHRU de Tours
- Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
- Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
- Urologicum Duisburg
- Medizinische Hochschule Hannover
- Universitaetsklinikum Koelnt
- Universitaetsklinikum Muenster
- Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
- Studienpraxis Urologie Drs. Feyerabend
- Jahn Ferenc Del-pesti Korhaz es Rendelointezet
- Debreceni Egyetem
- Petz Aladar Megyei Oktato Korhaz
- Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
- Szegedi Tudomanyegyetem
- Szent Borbala Hospital Tatabanya
- Haemek Medical Center - Afula
- Soroka Hospital
- Rambam Medical Center
- Hadassah Hospital
- Rabin Medical Center, Beilinson Hospital
- Sheba Medical Center Tel Hashomer
- Tel-Aviv Sourasky Medical Center
- Ospedale S. Donato - Asl 8 Arezzo
- Divisione di Oncologia - Istituto per la ricerca e cura del cancro
- Istituti Ospitalieri di Cremona, AO di Cremona
- Azienda Ospedaliera ''Vito Fazzi''
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
- Ospedale San Raffaele
- Fondazione IRCCS Istituto Nazionale dei Tumori
- European Institute of Oncology
- Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
- Aou San Luigi Gonzaga
- Istituto Oncologico Veneto Iov Irccs Padova
- Azienda Ospedaliero Universitaria Pisana
- ASL Napoli 2 Nord-SM delle Grazie Hospital
- Casa Sollievo della Sofferenza, IRCCS
- Ospedale S. Chiara
- Ospedale San Bortolo
- Pusan National University Hospital
- Kyungpook National University Chilgok Hospital
- Keimyung University Dongsan Hospital
- Chungnam National University Hospital
- Chonnam National University Hospital
- National Cancer Center
- Seoul National University Bundang Hospital
- Ajou University Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Gangnam Severance Hospital, Yonsei University Health System
- Samsung Medical Center
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Hospital Pulau Pinang
- Hospital Sultan Ismail
- Hospital Kuala Lumpur
- University Malaya Medical Centre
- Sarawak General Hospital
- Institut Kanser Negara - Clinical Research Center
- Centro de Investigación Clínica Gramel S.C.
- Consultorio de Especialidad en Urologia Privado
- Consultorio Privado
- Avix Investigacion Clinica, S.C.
- i Can Oncology Center
- Oncologia Integral Satelite
- Consultorio de Oncología Médica
- Consultorio Privado
- Reinier de Graaf Gasthuis
- Tergooiziekenhuizen
- Canisius-Wilhelminaziekenhuis
- Elisabeth-TweeSteden Ziekenhuis
- Auckland City Hospital
- Canterbury Urology Research Trust
- Dunedin Hospital
- Tauranga Hospital
- IN VIVO Sp. z o.o
- Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
- Centrum Onkologii im. Prof. F. Lukaszczyka
- Szpitale Pomorskie Sp. z o.o.
- Przychodnia Lekarska KOMED Roman Karaszewski
- Klinika MedTrials
- Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
- Medisport
- Urologica Praktyka Lekarska Adam Marcheluk
- Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
- Specjalistyczna przychodnia lekarska POLIMED
- Hosp. Garcia de Orta
- Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.
- Fundação Champalimaud
- Chln - Hosp. Santa Maria
- Puerto Rico Medical Research Center
- Altai Regional Oncology Dispensary
- Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
- Ivanovo Regional Oncology Dispensary
- Moscow City Clinical Hospital # 62
- Hertzen Oncology Research Institute
- Privolzhsky District Medical Centre
- Clinical Oncology Dispensary
- LLC Novaya Clinica
- Pyatigorsk Interdistrict Oncology Dispensary
- Private Medical Institution Euromedservice
- Leningrad Regional Oncology Dispensary
- Republican Oncology Dispensary
- Tomsk Cancer Research Institute
- Multifunctional clinical medical center 'Medical city'
- Bashkir State Medical University
- CancerCare Rondebosch
- Steve Biko Academic Hospital
- East Rand Urology Research Unit
- Hosp. Univ. A Coruña
- Hosp. de La Santa Creu I Sant Pau
- Hosp. Clinic I Provincial de Barcelona
- Hosp. Gral. Univ. De Castellon
- Institut Català D'Oncologia Girona
- Hosp. de Jerez de La Frontera
- Hosp. Univ. de La Princesa
- Hosp. Univ. Ramon Y Cajal
- Hosp. Univ. 12 de Octubre
- Hosp. Univ. La Paz
- Hosp. Univ. Hm Monteprincipe
- Hosp. Virgen de La Victoria
- Corporacio Sanitari Parc Tauli
- Hosp. Univ. Marques de Valdecilla
- Hosp. Virgen Del Rocio
- Hosp. Clinico Univ. de Valencia
- Salgrenska University hospital
- Urologiska Mottagningen
- Södersjukhuset
- Karolinska Universitetssjukhuset Solna
- Kaohsiung Chang Gung Memorial Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- Tungs' Taichung MetroHarbor Hospital
- National Taiwan University Hospital.
- Taipei Veterans General Hospital
- Chang-Gung Memorial Hospital, LinKou Branch
- King Chulalongkorn Memorial Hospital
- Ramathibodi Hospital
- Siriraj Hospital
- Adana Baskent Yuregir Hospital
- Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
- Memorial Ankara Hastanesi
- Gazi University Hospital
- Ankara University Medical Faculty
- Ankara Bilkent City Hospital
- Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
- Trakya University Medical Faculty
- Istanbul University Istanbul Medical Faculty
- Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
- Bakirkoy Training and Research Hospital
- T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
- Dokuz Eylul University Medical Faculty
- Izmir Medical Point Hospital
- Sakarya University Training and Research Hospital
- Medical Park Samsun Hastanesi
- Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
- Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
- Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
- Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
- Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
- Ivano-Frankivsk Regional Clinical Hospital
- Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
- Municipal non-profit enterprise 'Regional Center of Oncology'
- Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
- Kherson Regional Oncological Dispensary
- State Institution National Cancer Institute
- State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
- Kyiv Regional Oncological Dispensary
- Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
- Podilskiy Regional Center of Oncology
- Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
- Ysbyty Gwynedd
- Belfast City Hospital
- Brighton and Sussex University Hospitals NHS Trust
- Bristol Haematology and Oncology Centre
- Guy's Hospital
- Prince Of Wales Hospital
- Marie Curie Research Wing - Mount Vernon Hospital
- Raigmore Hospital
- University College London Hospitals NHSFT
- Churchill Hospital
- Royal Preston Hospital
- Royal Marsden Hospital
- Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Niraparib with Abiraterone Acetate plus Prednisone (AAP)
AA plus Prednisone (AAP)
Arm Description
Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
Outcomes
Primary Outcome Measures
Radiographic Progression-free Survival (rPFS)
rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) criteria and Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death from any cause.
Time to Symptomatic Progression
Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): a) the use of external beam radiation therapy for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; c) other cancer-related procedures; d) cancer-related morbid events; e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Time to Subsequent Therapy
Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention.
Full Information
NCT ID
NCT04497844
First Posted
July 31, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04497844
Brief Title
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Acronym
AMPLITUDE
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 for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
May 27, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
Detailed Description
Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AAP) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guidelines. Niraparib is an investigational agent in the castration-sensitive cancer population and has been approved for the treatment of ovarian cancer. The addition of niraparib to the AAP backbone regimen may improve initial disease control and long-term outcomes compared with AAP alone in a biomarker selected population. The study will consist of 4 phases; a Prescreening Phase for biomarker evaluation for eligibility only, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Efficacy evaluations include the following: tumor measurements by computed tomography (CT), magnetic resonance imaging (MRI; abdomen, chest, and pelvis), Technetium-99m (99mTc) bone scans, serum prostate sensitive antigen (PSA) evaluations, and patient reported outcomes (PROs). Safety evaluations include incidence of adverse events and clinical laboratory parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-sensitive Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
696 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Niraparib with Abiraterone Acetate plus Prednisone (AAP)
Arm Type
Experimental
Arm Description
Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.
Arm Title
AA plus Prednisone (AAP)
Arm Type
Active Comparator
Arm Description
Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Niraparib
Intervention Description
Participants will receive Niraparib 200 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate (AA)
Intervention Description
Participants will receive AA 1000 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Participants will receive prednisone 5 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo for Niraparib
Intervention Description
Participants will receive matching placebo for Niraparib once daily.
Primary Outcome Measure Information:
Title
Radiographic Progression-free Survival (rPFS)
Description
rPFS is defined as time from randomization date to date of radiographic progression or death, whichever occurs first. Radiographic progression will be evaluated by Prostate Cancer Working Group 3 (PCWG3) criteria and Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Time Frame
Up to 47 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from date of randomization to date of death from any cause.
Time Frame
Up to 78 months
Title
Time to Symptomatic Progression
Description
Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): a) the use of external beam radiation therapy for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; c) other cancer-related procedures; d) cancer-related morbid events; e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Time Frame
Up to 47 months
Title
Time to Subsequent Therapy
Description
Time to Subsequent Therapy is defined as the time from date of randomization to the date of initiation of subsequent therapy for prostate cancer.
Time Frame
Up to 47 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. AE does not necessarily have a causal relationship with intervention.
Time Frame
Up to 78 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Pathological diagnosis of prostate adenocarcinoma
Must have appropriate deleterious homologous recombination repair (HRR) gene alteration
Metastatic disease as documented by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (for soft tissue lesions) or 99mTc bone scan (for bone lesions). Participants with a single bone lesion on Technetium-99m (99mTc) bone scan with no other non-nodal metastatic disease must have confirmation of bone metastasis by CT or MRI. Participants with lymph node-only disease are not eligible
Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase
Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC): (a) maximum of 1 course of radiation and 1 surgical intervention for symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal cord compression or obstructive symptoms). Participants with radiation or surgical interventions to all known sites of metastatic disease will be excluded from trial participation. Radiation must be completed prior to randomization (b) Up to a maximum of 6 months of ADT prior to randomization; (c) Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to randomization (d) Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to randomization
Exclusion criteria:
Prior treatment with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARP inhibitor)
History of adrenal dysfunction
Long-term use of systemically administered corticosteroids (greater than [>] 5 milligrams [mg] of prednisone or the equivalent) during the study is not allowed. Short-term use (<=4 weeks, including taper) and locally administered steroids (for example, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated
History or current diagnosis of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers Of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Urological Associates of Southern Arizona, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Greater Los Angeles VA Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
San Bernardino Urological Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
University of San Francisco California
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Colorado Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Eastern Connecticut Hematology & Oncology Assoc.
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Advanced Urology Institute
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Urology of Indiana
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
First Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Maryland Oncology Hematology, PA
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Chesapeake Urology Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Mosaic Life Care
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
St. Louis VA Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
GU Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
New York Oncology Hematology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Manhattan VAMC
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Associated Medical Professionals
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Durham VAMC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Oncology Specialists
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Keystone Urology Specialists
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Ralph H. Johnson Veterans Affairs Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Prisma Health
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Texas Oncology-Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology-Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76201
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Texas Oncology P.A.
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Texas Oncology-Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Commonwealth University - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
VA Puget Sound Healthcare System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
Centro Oncológico Korben
City
Buenos Aires
ZIP/Postal Code
C1426AGE
Country
Argentina
Facility Name
Hospital Militar Cosme Argerich
City
C.a.b.a.
ZIP/Postal Code
C1426BOR
Country
Argentina
Facility Name
CINME - Centro de Investigaciones Metabolicas
City
Caba
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
CIPREC Arenales
City
Caba
ZIP/Postal Code
C1061AAS
Country
Argentina
Facility Name
Centro de Urologia (CDU)
City
Ciudad Automoma Buenos Aires
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Clínica Adventista Belgrano
City
Ciudad De Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Centro Urologico Profesor Bengio
City
Cordoba
ZIP/Postal Code
X5000KPH
Country
Argentina
Facility Name
Instituto Médico de Río Cuarto
City
Cordoba
ZIP/Postal Code
X5800
Country
Argentina
Facility Name
Hospital Privado de Cordoba
City
Cordoba
ZIP/Postal Code
XX5016KEH
Country
Argentina
Facility Name
Hospital Privado de Comunidad
City
Mar Del Plata
ZIP/Postal Code
B7602CBM
Country
Argentina
Facility Name
Centro de Investigacion Pergamino SA
City
Pergamino
ZIP/Postal Code
B2700CPM
Country
Argentina
Facility Name
ARS Médica
City
San Salvador De Jujuy
ZIP/Postal Code
Y4600AFW
Country
Argentina
Facility Name
Sunshine Coast University Hospital
City
Birtinya
ZIP/Postal Code
4575
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Facility Name
Ashford Cancer Centre
City
Kurralta Park
ZIP/Postal Code
5037
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Macquarie University Hospital
City
North Ryde
ZIP/Postal Code
2109
Country
Australia
Facility Name
ICON Cancer Care
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
St John of God Subiaco Hospital
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Facility Name
Bobruisk Interregional Oncological Dispensary
City
Bobruisk
ZIP/Postal Code
213825
Country
Belarus
Facility Name
Brest Regional Oncology Dispensary
City
Brest
ZIP/Postal Code
224027
Country
Belarus
Facility Name
Gomel Regional Clinical Oncology Dispensary
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
Grodno University Hospital
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
State Institution N.N. Alexandrov Republican Scientific and
City
Lesnoy
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Minsk city Clinical Oncological Dispensary
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Mogilev Regional Hospital
City
Mogilev
ZIP/Postal Code
212018
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
ZNA Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Grand Hopital de Charleroi, site Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Jolimont
City
Haine-St-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHC MontLegia
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Namur - Site Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Clinique St Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
GZA Ziekenhuizen
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Fundacao Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Cetus Oncologia
City
Belo Horizonte
ZIP/Postal Code
30110-022
Country
Brazil
Facility Name
PERSONAL - Oncologia de Precisão e Personalizada
City
Belo Horizonte
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
CIONC - Centro Integrado de Oncologia de Curitiba
City
Curitiba
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
City
Florianopolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Pronutrir
City
Fortaleza
ZIP/Postal Code
60 810180
Country
Brazil
Facility Name
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Fundação São Francisco Xavier
City
Ipatinga
ZIP/Postal Code
35162 189
Country
Brazil
Facility Name
Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia
City
Joinville
ZIP/Postal Code
89201-260
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
UPCO Unidade de Pesquisa Clinica em Oncologia
City
Pelotas
ZIP/Postal Code
96020 080
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
ZIP/Postal Code
90160-093
Country
Brazil
Facility Name
MultiHemo Servicos Medicos S.A
City
Recife
ZIP/Postal Code
CEP: 50070-460
Country
Brazil
Facility Name
Ministerio da Saude - Instituto Nacional do Cancer
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Universidade do Estado do Rio de Janeiro - UERJ
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Oncoclínicas Rio de Janeiro S.A.
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
Nucleo de Oncologia da Bahia
City
Salvador
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
Hospital Sao Rafael
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Fundacao do ABC - Centro Universitario FMABC
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa São Lucas
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01421-000
Country
Brazil
Facility Name
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
City
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
City
Sorocaba
ZIP/Postal Code
18030-005
Country
Brazil
Facility Name
Instituto do Cancer Arnaldo Vieira de Carvalho
City
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
ZIP/Postal Code
01323-900
Country
Brazil
Facility Name
Núcleo de Pesquisa São Camilo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Centro Oncológico do Triângulo
City
Uberlândia
ZIP/Postal Code
38408-150
Country
Brazil
Facility Name
MHAT Deva Maria
City
Burgas
ZIP/Postal Code
8001
Country
Bulgaria
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
District Oncology Dispensary with In-Patient Stationary - Plovdiv
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Multifunctional Hospital for Active Treatment for Women Health Nadezhda
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment in Oncology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
UMHAT Sofia Med
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Comprehensive Cancer Center
City
Vratsa
ZIP/Postal Code
3001
Country
Bulgaria
Facility Name
Prostate Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
British Columbia Cancer Agency (BCCA) - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Island Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
McMaster Institute of Urology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Kingston Health Sciences Centre, Kingston General Health Research Institute
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network (UHN) Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
McGill University - Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
ZIP/Postal Code
610072
Country
China
Facility Name
Western Theater General Hospital of the Chinese People's Liberation Army
City
Chengdu
ZIP/Postal Code
610083
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Southwest Hospital, The Third Military Medical University
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
GuangZhou
ZIP/Postal Code
430030
Country
China
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510289
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Jiangsu Province Cancer Hospital
City
Nanjing
ZIP/Postal Code
210000
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
The First Affiliated Hospital of Ningbo University
City
Ningbo
ZIP/Postal Code
315010
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
The Fifth People's Hospital of Shanghai, Fudan University
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Huadong Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200400
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Second Affiliated Hospital of Soochow University
City
SuZhou
ZIP/Postal Code
200233
Country
China
Facility Name
The First Affliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
FN Hradec Kralove, Urologicka klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Krajská nemocnice Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Uromedical Center s.r.o.
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Urologicka klinika 1.LF UK a VFN
City
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Næstved Hospital
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
Facility Name
Institut de Cancérologie de l'Ouest (ICO)
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon Cedex 9
ZIP/Postal Code
84918
Country
France
Facility Name
CHRU De Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Prive Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Regional du Cancer de Montpellier Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Polyclinique de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
CHU De Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hopitalier Inter-Communal De Cornouaille
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
HIA Begin
City
Saint Mande
ZIP/Postal Code
94163
Country
France
Facility Name
Institut de Cancérologie de Loire
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Clinique Sainte Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
32151
Country
France
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47169
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Koelnt
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum rechts der Isar - III. Med. Klinik und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Studienpraxis Urologie Drs. Feyerabend
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Szent Borbala Hospital Tatabanya
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Haemek Medical Center - Afula
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Soroka Hospital
City
Beer-Sheva
ZIP/Postal Code
85101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Hospital
City
Jerusalem
ZIP/Postal Code
91200
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petach Tikvah
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Ospedale S. Donato - Asl 8 Arezzo
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Divisione di Oncologia - Istituto per la ricerca e cura del cancro
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Istituti Ospitalieri di Cremona, AO di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Azienda Ospedaliera ''Vito Fazzi''
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Aou San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Istituto Oncologico Veneto Iov Irccs Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
ASL Napoli 2 Nord-SM delle Grazie Hospital
City
Pozzuoli
ZIP/Postal Code
80078
Country
Italy
Facility Name
Casa Sollievo della Sofferenza, IRCCS
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale S. Chiara
City
Trento
Country
Italy
Facility Name
Ospedale San Bortolo
City
Vicenza
Country
Italy
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
ZIP/Postal Code
81100
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Institut Kanser Negara - Clinical Research Center
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Centro de Investigación Clínica Gramel S.C.
City
Ciudad de Mexico
ZIP/Postal Code
3720
Country
Mexico
Facility Name
Consultorio de Especialidad en Urologia Privado
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Consultorio Privado
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Avix Investigacion Clinica, S.C.
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
i Can Oncology Center
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Oncologia Integral Satelite
City
Naucalpan
ZIP/Postal Code
53100
Country
Mexico
Facility Name
Consultorio de Oncología Médica
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Consultorio Privado
City
Zapopan
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Reinier de Graaf Gasthuis
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Tergooiziekenhuizen
City
Hilversum
ZIP/Postal Code
1213XZ
Country
Netherlands
Facility Name
Canisius-Wilhelminaziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Elisabeth-TweeSteden Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Canterbury Urology Research Trust
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin Central
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
IN VIVO Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Centrum Onkologii im. Prof. F. Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Przychodnia Lekarska KOMED Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Klinika MedTrials
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Medisport
City
Lublin
ZIP/Postal Code
20-223
Country
Poland
Facility Name
Urologica Praktyka Lekarska Adam Marcheluk
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Specjalistyczna przychodnia lekarska POLIMED
City
Wroclaw
ZIP/Postal Code
53-329
Country
Poland
Facility Name
Hosp. Garcia de Orta
City
Almada
ZIP/Postal Code
2805-607
Country
Portugal
Facility Name
Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.
City
Coimbra
ZIP/Postal Code
3000075
Country
Portugal
Facility Name
Fundação Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Chln - Hosp. Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Puerto Rico Medical Research Center
City
Hato Rey
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Altai Regional Oncology Dispensary
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital # 62
City
Moscow
ZIP/Postal Code
125130
Country
Russian Federation
Facility Name
Hertzen Oncology Research Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Privolzhsky District Medical Centre
City
Nizhny Novgorod
ZIP/Postal Code
603001
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
LLC Novaya Clinica
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Pyatigorsk Interdistrict Oncology Dispensary
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Private Medical Institution Euromedservice
City
Saint Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Republican Oncology Dispensary
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Tomsk Cancer Research Institute
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Multifunctional clinical medical center 'Medical city'
City
Tyumen
ZIP/Postal Code
625041
Country
Russian Federation
Facility Name
Bashkir State Medical University
City
Ufa
ZIP/Postal Code
450083
Country
Russian Federation
Facility Name
CancerCare Rondebosch
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Steve Biko Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
East Rand Urology Research Unit
City
Vosloorus
ZIP/Postal Code
1475
Country
South Africa
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Gral. Univ. De Castellon
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Institut Català D'Oncologia Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hosp. de Jerez de La Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. Hm Monteprincipe
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hosp. Clinico Univ. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Salgrenska University hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Urologiska Mottagningen
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
17164
Country
Sweden
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Tungs' Taichung MetroHarbor Hospital
City
Taichung
ZIP/Postal Code
435
Country
Taiwan
Facility Name
National Taiwan University Hospital.
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, LinKou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Adana Baskent Yuregir Hospital
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Gazi University Hospital
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
City
Bursa
ZIP/Postal Code
16310
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Bakirkoy Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Izmir Medical Point Hospital
City
Izmir
ZIP/Postal Code
35530
Country
Turkey
Facility Name
Sakarya University Training and Research Hospital
City
Sakarya
ZIP/Postal Code
54100
Country
Turkey
Facility Name
Medical Park Samsun Hastanesi
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Municipal Non-profit enterprise 'Bukovinian clinical oncology center'
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
City
Kamianske
ZIP/Postal Code
51900
Country
Ukraine
Facility Name
Municipal non-profit enterprise 'Regional Center of Oncology'
City
Khakhiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Kherson Regional Oncological Dispensary
City
Kherson
ZIP/Postal Code
73035
Country
Ukraine
Facility Name
State Institution National Cancer Institute
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Kyiv Regional Oncological Dispensary
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Podilskiy Regional Center of Oncology
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Ysbyty Gwynedd
City
Bangor
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Guy's Hospital
City
Great Maze Pond
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Prince Of Wales Hospital
City
Grimsby
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
Marie Curie Research Wing - Mount Vernon Hospital
City
Hillingdon
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
University College London Hospitals NHSFT
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
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