Clinical trial NCT03748641: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Castration-Resistant Prostatic Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 765
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* HRR gene alteration (as identified by the sponsor's required assays) as follows:

  1. Cohort 1: positive for HRR gene alteration
  2. Cohort 2: not positive for DRD (that is, HRR gene alteration)
  3. Cohort 3: eligible by HRR status
* Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
* Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
* Able to continue GnRHa during the study if not surgically castrate
* Score of \<= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion Criteria:

* Prior treatment with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor
* Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone \[AAP\] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
* Symptomatic brain metastases
* History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) \<= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Primary outcomes:
measure: Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to 32 months
measure: Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to 32 months
Secondary outcomes:
measure: Cohort 1: Overall Survival (OS)
timeFrame: Up to 97 months
measure: Cohort 1: Time to Symptomatic Progression
timeFrame: Up to 97 months
measure: Cohort 1: Time to Initiation of Cytotoxic Chemotherapy
timeFrame: Up to 97 months
measure: Observed Plasma Concentrations of Niraparib
timeFrame: Up to 97 months
measure: Observed Plasma Concentrations of Abiraterone
timeFrame: Up to 97 months
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 96 months
measure: Number of Participants With Treatment-Emergent Adverse Events by Severity
timeFrame: Up to 96 months
measure: Number of Participants With Abnormalities in Laboratory Values
timeFrame: Up to 96 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, P.C.
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Riverside
country: United States
facility: Kaiser Permanente
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic Pharm
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Lakewood
country: United States
facility: Colorado Clinical Research
state: Colorado
city: West Haven
country: United States
facility: VA Connecticut Healthcare
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Division Of Hematology/oncology
state: Florida
city: Hines
country: United States
facility: Veterans Affairs Medical Ctr
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Bethesda
country: United States
facility: Rcca Md, Llc
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Massachusetts General
state: Massachusetts
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology, P.C
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Mount Laurel
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Syracuse
country: United States
facility: Upstate Cancer Center
state: New York
city: Middleburg Heights
country: United States
facility: Helios Clinical Research, LLC
state: Ohio
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salem
country: United States
facility: Salem VA Medical Center
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLCC
state: Virginia
city: Tacoma
country: United States
facility: NorthWest Medical Specialties, PLLC
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Buenos Aires
country: Argentina
facility: Centro Oncológico Korben
city: Ciudad Automoma Buenos Aires
country: Argentina
facility: Centro de Urologia (CDU)
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CEMIC Saavedra
city: Cordoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de Comunidad
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA
city: Rosario
country: Argentina
facility: Sanatorio Britanico de Rosario
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: San Salvador De Jujuy
country: Argentina
facility: ARS Médica
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Benowa
country: Australia
facility: Pindara Private Hospital
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Darlinghurst
country: Australia
facility: St Vincent s Hospital Sydney
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Macquarie University
country: Australia
facility: Macquarie University
city: Malvern
country: Australia
facility: Eye Surgery Associates
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Nedlands
country: Australia
facility: Hollywood Private Hospital
city: Randwick
country: Australia
facility: Prince Of Wales Hospital
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Wollongong
country: Australia
facility: Wollongong Private Hospital
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Antwerpen
country: Belgium
facility: ZAS Augustinus
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi, site Notre Dame
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: PERSONAL Oncologia de Precisao e Personalizada
city: Brasilia
country: Brazil
facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
city: Curitiba
country: Brazil
facility: CIONC Centro Integrado de Oncologia de Curitiba
city: Fortaleza
country: Brazil
facility: Pronutrir
city: Goiania
country: Brazil
facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
city: Ipatinga
country: Brazil
facility: Fundacao Sao Francisco Xavier
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
city: Maceio
country: Brazil
facility: Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Rio de Janeiro
country: Brazil
facility: Ministerio da Saude Instituto Nacional do Cancer
city: Rio de Janeiro
country: Brazil
facility: Universidade do Estado do Rio de Janeiro - UERJ
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
city: Salvador
country: Brazil
facility: Hospital Santa Isabel
city: Santo Andre
country: Brazil
facility: Fundacao do ABC Centro Universitario FMABC
city: Sao Paulo
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa São Lucas
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
city: Sorocaba
country: Brazil
facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
city: São Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Tres Lagoas
country: Brazil
facility: Instituto do Cancer De Tres Lagoas
city: Burgas
country: Bulgaria
facility: MHAT Deva Maria
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncology EAD
city: Varna
country: Bulgaria
facility: SHATOD 'Dr. Marko Antonov Markov'
city: Vratsa
country: Bulgaria
facility: Comprehensive Cancer Center
city: Calgary
country: Canada
facility: Southern Alberta Institute of Urology / Prostate Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency BCCA Vancouver Centre
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency Vancouver Island Centre
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Institute of Urology
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Centre de Recherche du CHUM
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital of Peking University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Chengdu
country: China
facility: Sichuan Provincial Peoples Hospital
city: Chongqing
country: China
facility: Southwest Hospital, The Third Military Medical University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University
city: GuangZhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Ningbo
country: China
facility: Drug clinical trial ethics committee of Ningbo First Hospital
city: ShangHai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: ShangHai
country: China
facility: ShangHai Huadong Hospital
city: ShangHai
country: China
facility: The Fifth People's Hospital of Shanghai, Fudan University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Hradec Králove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Liberec
country: Czechia
facility: Krajská nemocnice Liberec
city: Olomouc
country: Czechia
facility: Uromedical Center s.r.o.
city: Pardubice
country: Czechia
facility: Multiscan s.r.o.
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen, Urologicka klinika
city: Praha 2
country: Czechia
facility: Urologicka klinika 1 LF UK a VFN
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice, Onkologicka klinika
city: Uherske Hradiste
country: Czechia
facility: Uherskohradistska nemocnice a.s.
city: Besancon
country: France
facility: CHRU De Besancon
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier Val d'Aurelle
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Nice Cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges-Pompidou
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l Ouest ICO
city: Saint Mande
country: France
facility: HIA Begin
city: Strasbourg Cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Magdeburg
country: Germany
facility: Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie Drs. Feyerabend
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Urológia Klinika
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
city: Pécs
country: Hungary
facility: Uro-Clin Kft.
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Beer Yaakov
country: Israel
facility: Asaf Harofe Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center Tel Hashomer
city: Faenza
country: Italy
facility: AUSL Romagna - Ospedale di Faenza
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Oncologia Medica A - Ist Naz Tumori G Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto Iov Irccs Padova
city: Parma
country: Italy
facility: Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
city: Perugia
country: Italy
facility: Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli IRCCS
city: Roma
country: Italy
facility: Campus Bio Medico di Roma
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria Terni
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza
city: Trento
country: Italy
facility: Ospedale Santa Chiara Trento
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kota Kinabalu
country: Malaysia
facility: Hospital Likas
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Aguascalientes
country: Mexico
facility: iBiomed Research Unit
city: Ciudad de Mexico
country: Mexico
facility: Mexico Centre for Clinical Research, S.A. de C.V.
city: Durango
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado
city: Monterrey
country: Mexico
facility: Avix Investigacion Clinica S C
city: Zapopan
country: Mexico
facility: Consultorio Privado
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Leidschendam
country: Netherlands
facility: MC Haaglanden Lok Antoniushove - Afd.Interne - INT
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis (St. Antonius Hospital)
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelminaziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medical Center
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im Prof F Lukaszczyka
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp z o o
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
city: Siedlce
country: Poland
facility: Urologica Praktyka Lekarska Adam Marcheluk
city: Szczecin
country: Poland
facility: Pomorski Uniwersytet Medyczny w Szczecinie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Coimbra
country: Portugal
facility: Hospitais da universidade de Coimbra
city: Coimbra
country: Portugal
facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
city: Lisbon
country: Portugal
facility: Champalimaud Foundation Champalimaud Centre
city: Porto
country: Portugal
facility: H. Santo António - Centro Hospitalar do Porto
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
city: Barnaul
country: Russian Federation
facility: Altai Regional Oncology Dispensary
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kursk
country: Russian Federation
facility: GUZ Kursk Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital # 62
city: Nizhny Novgorod
country: Russian Federation
facility: Clinical Diagnostic Centre of Nizhny Novgorod Region
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: LLC Novaya Clinica
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Interdistrict Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Private Medical Institution Euromedservice
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: Sankt-Peterburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies
city: Saransk
country: Russian Federation
facility: Republican Oncology Dispensary
city: Sochi
country: Russian Federation
facility: Oncologic Dispensary No.2
city: Tambov
country: Russian Federation
facility: Tambov Regional Oncology Clinical Dispansary
city: Tomsk
country: Russian Federation
facility: Tomsk Cancer Research Institute
city: Tyumen
country: Russian Federation
facility: Medical-sanitary unit 'Neftyanik'
city: Vologda
country: Russian Federation
facility: Vologda Regional Oncological Dispensary
city: Johannesburg
country: South Africa
facility: Clinresco Centres Pty Ltd
city: Pretoria
country: South Africa
facility: Clinical Research Unit
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Málaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Pozuelo de Alarcon
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Tungs' Taichung MetroHarbor Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center Yong Kang
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Adana
country: Turkey
facility: Cukurova University, Faculty of Medicine
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Training and Research Hospital
city: Istanbul
country: Turkey
facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
city: Izmir
country: Turkey
facility: IEU Medical Point Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Cherkasy
country: Ukraine
facility: CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
city: Dnipo
country: Ukraine
facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
city: Dnipro
country: Ukraine
facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Khakhiv
country: Ukraine
facility: Municipal non-profit enterprise 'Regional Center of Oncology'
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval
city: Kyiv
country: Ukraine
facility: State Institution National Cancer Institute
city: Kyiv
country: Ukraine
facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
city: Poltava
country: Ukraine
facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'
city: Uzhgorod
country: Ukraine
facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
city: London
country: United Kingdom
facility: UCL Cancer Institute
city: Torquay
country: United Kingdom
facility: Torbay Hospital-Devon
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: