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Brief Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
Official Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer
Study ID: NCT03748641
Brief Summary: The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Urology Centers Of Alabama, Homewood, Alabama, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Urological Associates of Southern Arizona, P.C., Tucson, Arizona, United States
Arkansas Urology, Little Rock, Arkansas, United States
Kaiser Permanente, Riverside, California, 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
The Urology Center of Colorado, Denver, Colorado, United States
Colorado Clinical Research, Lakewood, Colorado, United States
VA Connecticut Healthcare, West Haven, Connecticut, United States
Bay Pines VA Healthcare System, Bay Pines, Florida, United States
Advanced Urology Institute, Daytona Beach, Florida, United States
University of Florida Health Jacksonville, Jacksonville, Florida, United States
Mayo Clinic - Division Of Hematology/oncology, Jacksonville, Florida, United States
Veterans Affairs Medical Ctr, Hines, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
First Urology, Jeffersonville, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Norton Healthcare, Louisville, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Rcca Md, Llc, Bethesda, Maryland, United States
Chesapeake Urology Research Associates, Towson, Maryland, United States
Massachusetts General, Boston, Massachusetts, United States
Michigan Institute of Urology, Troy, Michigan, United States
Kansas City Veterans Affairs Medical Center, Kansas City, Missouri, United States
Adult Pediatric Urology & Urogynecology, P.C, Omaha, Nebraska, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Delaware Valley Urology, LLC, Mount Laurel, New Jersey, United States
New York Oncology Hematology, Albany, New York, 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
Upstate Cancer Center, Syracuse, New York, United States
Helios Clinical Research, LLC, Middleburg Heights, Ohio, United States
Oregon Urology Institute, Springfield, Oregon, United States
MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
Lancaster Urology, Lancaster, Pennsylvania, United States
VA Pittsburgh, Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology Associates, Nashville, Tennessee, United States
Houston Metro Urology, Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Salem VA Medical Center, Salem, Virginia, United States
Urology of Virginia, PLCC, Virginia Beach, Virginia, United States
NorthWest Medical Specialties, PLLC, Tacoma, Washington, United States
Hospital Aleman, Buenos Aires, , Argentina
Centro Oncológico Korben, 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
Instituto de Investigaciones Clinicas Mar del Plata, Mar Del Plata, Buenos Aires, , Argentina
Hospital Privado de Comunidad, Mar Del Plata, , Argentina
Centro de Investigacion Pergamino SA, Pergamino, , Argentina
Sanatorio Britanico de Rosario, Rosario, , Argentina
Sanatorio Parque, Rosario, , Argentina
ARS Médica, San Salvador De Jujuy, , Argentina
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, , Australia
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, , Belgium
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
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Hospital Ernesto Dornelles, Porto Alegre, , Brazil
Ministerio da Saude - Instituto Nacional do Cancer, Rio de Janeiro, , Brazil
Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, , Brazil
Oncoclinicas Rio de Janeiro S A, Rio de Janeiro, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro, , Brazil
Hospital Santa Isabel, Salvador, , Brazil
Fundacao do ABC - Centro Universitario FMABC, Santo Andre, , Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo, Sao Paulo, , Brazil
Instituto de Ensino e Pesquisa São Lucas, 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
Fundacao Antonio Prudente A C Camargo Cancer Center, Sao Paulo, , Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE, Sao Paulo, , Brazil
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado, Sorocaba, , Brazil
Núcleo de Pesquisa São Camilo, São Paulo, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), São Paulo, , Brazil
Instituto do Cancer De Tres Lagoas, Tres Lagoas, , Brazil
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, , Bulgaria
Southern Alberta Institute of Urology / Prostate Cancer Centre, Calgary, Alberta, Canada
British Columbia Cancer Agency BCCA Vancouver Centre, Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Centre, Victoria, British Columbia, Canada
McMaster Institute of Urology, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre), Kingston, Ontario, Canada
Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
University Health Network UHN Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre de Recherche du CHUM, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Peking University First Hospital, Beijing, , China
Beijing Friendship Hospital, Beijing, , China
Beijing Cancer Hospital of Peking University, Beijing, , China
Peking University Third Hospital, Beijing, , China
Beijing Hospital, Beijing, , China
Sichuan Provincial Peoples Hospital, Chengdu, , China
Southwest Hospital, The Third Military Medical University, Chongqing, , China
Chongqing University Cancer Hospital, Chongqing, , China
Fujian Medical University Union Hospital, Fuzhou, , China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University, Guangzhou, , China
Guangzhou First Municipal People's Hospital, GuangZhou, , China
Nanjing Drum Tower Hospital, Nanjing, , China
Jiangsu Cancer Hospital, Nanjing, , China
Drug clinical trial ethics committee of Ningbo First Hospital, Ningbo, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine, ShangHai, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Huashan Hospital Fudan University, 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, , China
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, , Czechia
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, , France
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, , Germany
Semmelweis Egyetem, Urológia Klinika, Budapest, , Hungary
Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály, 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, , Hungary
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, , Israel
AUSL Romagna - Ospedale di Faenza, Faenza, , Italy
Ospedale San Raffaele, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, 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
Fondazione Policlinico Universitario A Gemelli IRCCS, Roma, , Italy
Campus Bio Medico di Roma, 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, , Italy
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Chonnam National University Hospital, Gwangju, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Ajou University Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , 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
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
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, , Malaysia
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, , Mexico
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, , Netherlands
Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza, Bydgoszcz, , Poland
Centrum Onkologii im. Prof. F. Lukaszczyka, 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, Wrocław, , Poland
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, , Portugal
VA Caribbean Healthcare System, San Juan, , Puerto Rico
Altai Regional Oncology Dispensary, Barnaul, , Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
GUZ Kursk Regional Oncology Dispensary, Kursk, , Russian Federation
Russian Scientific Center of Roentgenoradiology, Moscow, , Russian Federation
Moscow City Clinical Hospital # 62, 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, , Russian Federation
Clinresco Centres Pty Ltd, Johannesburg, , South Africa
Clinical Research Unit, Pretoria, , South Africa
Hosp. Del Mar, Barcelona, , Spain
Hosp. de La Santa Creu I Sant Pau, Barcelona, , Spain
Hosp. Clinic de Barcelona, Barcelona, , Spain
Hospital Juan Canalejo, Coruña, , Spain
Hosp. de Jerez de La Frontera, Jerez de la Frontera, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Clinico San Carlos, 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, , Spain
Södersjukhuset, Stockholm, , Sweden
Karolinska Universitetssjukhuset Solna, Stockholm, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
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, , Taiwan
Cukurova University, Faculty of Medicine, Adana, , Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, , Turkey
Ankara Bilkent Sehir Hastanesi, Ankara, , Turkey
Akdeniz University Medical Faculty, Antalya, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Bakirkoy Training and Research Hospital, Istanbul, , Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
IEU Medical Point Hospital, Izmir, , Turkey
Kocaeli University Medical Faculty, Kocaeli, , Turkey
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
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council, Dnipro, , Ukraine
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4, 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 National Cancer Institute, Kyiv, , Ukraine
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center, 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, , Ukraine
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 Kingdom
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR