Clinical trial NCT03871816: A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Official title: Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Prostate Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 14532
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population consists of male participants diagnosed with metastatic prostate cancer who will be evaluated for the prevalence for DNA-repair gene defects.

Brief summary: The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic (Stage IV) prostate cancer (PC), confirmed by either biopsy of a metastatic tumor site or history of localized disease supported by metastatic disease on imaging studies (that is \[i.e.\], clearly noted in hospital/clinical records)
* Signed Informed consent form (ICF)
* No condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example \[e.g.\], compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Willing to provide a saliva, blood, and/or archival tumor tissue sample for genomic analysis
* No prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
* No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial

Primary outcomes:
measure: Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Prostate Cancer as an Estimate for Prevalence
timeFrame: Approximately 2.4 years
measure: Percentage of Participants who Meet Biomarker Eligibility Criteria for Other Niraparib Interventional Studies
timeFrame: Approximately 2.4 years
Secondary outcomes:
measure: Percentage of Participants with 4 or more DNA-repair Gene Defects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and with Metastatic Hormone Sensitive PC (HSPC) as an Estimate for Prevalence
timeFrame: Approximately 2.4 years
measure: Percentage of Participants with 1 or more DNA-repair gene defects with Metastatic Prostate Cancer as an Estimate for Prevalence
timeFrame: Approximately 2.4 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, P.C.
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Long Beach
country: United States
facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach
state: California
city: Riverside
country: United States
facility: Kaiser Permanente
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic Pharm
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Golden
country: United States
facility: Foothills Urology - Golden Off
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Assoc.
state: Connecticut
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Cancer Care
state: Hawaii
city: Chicago Ridge
country: United States
facility: Affiliated Oncologists, LLC
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology
state: Indiana
city: South Bend
country: United States
facility: Beacon Medical Group Clinical Research
state: Indiana
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Covington
country: United States
facility: Pontchartrain Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Frederick
country: United States
facility: Frederick Health Hospital - James M Stockman Cancer Institute
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Plymouth
country: United States
facility: Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Lansing
country: United States
facility: Edward W Sparrow Hospital
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Saint Joseph
country: United States
facility: Mosaic Life Care
state: Missouri
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology, P.C
state: Nebraska
city: Omaha
country: United States
facility: GU Research Network
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Tisch Cancer Institution
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Syracuse
country: United States
facility: Upstate Cancer Center
state: New York
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists PC
state: Oregon
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Centers for Advanced Urology LLC d b a MidLantic Urology
state: Pennsylvania
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Horsham
country: United States
facility: Consultants in Medical Oncology and Hematology, P.C. - Abington
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Myrtle Beach
country: United States
facility: Atlantic Urology Clinics
state: South Carolina
city: Abilene
country: United States
facility: Texas Onc.
state: Texas
city: Amarillo
country: United States
facility: Texas Oncology-Amarillo
state: Texas
city: Austin
country: United States
facility: Texas Oncology-Austin
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology-Denton South
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology, P.A. - Flower Mound
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Willowbrook
state: Texas
city: Longview
country: United States
facility: Texas Oncology P.A.
state: Texas
city: McAllen
country: United States
facility: Texas Oncology P.A.
state: Texas
city: Mesquite
country: United States
facility: Texas Oncology-Mesquite
state: Texas
city: Midland
country: United States
facility: Texas Oncology-Midland Allison Cancer Center
state: Texas
city: Paris
country: United States
facility: Texas Oncology, P.A. - Paris
state: Texas
city: Plano
country: United States
facility: Texas Oncology P A
state: Texas
city: Plano
country: United States
facility: Texas Oncology P.A.
state: Texas
city: San Antonio
country: United States
facility: University of Texas at San Antonio
state: Texas
city: Waco
country: United States
facility: Texas Oncology -Waco
state: Texas
city: Webster
country: United States
facility: Texas Oncology Deke Slayton Cancer Center
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology P.A.
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: INOVA
state: Virginia
city: Leesburg
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Asc
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLCC
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialists
state: Washington
city: Janesville
country: United States
facility: Building Oncology Research
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Buenos Aires
country: Argentina
facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
city: Buenos Aires
country: Argentina
facility: Centro Oncológico Korben
city: Caba
country: Argentina
facility: CINME - Centro de Investigaciones Metabolicas
city: Ciudad Automoma Buenos Aires
country: Argentina
facility: Centro de Urologia (CDU)
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CEMIC Saavedra
city: Ciudad Autonoma de
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Clínica Adventista Belgrano
city: Cordoba
country: Argentina
facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Centro Urologico Profesor Bengio
city: Cordoba
country: Argentina
facility: Hospital Privado - Centro Medico de Cordoba
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 Parque
city: San Salvador De Jujuy
country: Argentina
facility: ARS Médica
city: Benowa
country: Australia
facility: Pindara Private Hospital
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Darlinghurst
country: Australia
facility: St Vincent's hospital
city: East Albury
country: Australia
facility: Border Medical Oncology
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Randwick
country: Australia
facility: Prince Of Wales Hospital
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Bobruisk
country: Belarus
facility: Bobruisk Interregional Oncological Dispensary
city: Brest
country: Belarus
facility: Brest Regional Oncology Dispensary
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Oncology Dispensary
city: Grodno
country: Belarus
facility: Grodno University Hospital
city: Lesnoy
country: Belarus
facility: State Institution N.N. Alexandrov Republican Scientific and
city: Minsk
country: Belarus
facility: Minsk city Clinical Oncological Dispensary
city: Mogilev
country: Belarus
facility: Mogilev Regional Hospital
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Charleroi
country: Belgium
facility: Clinique Notre Dame de Grâce
city: Haine-Saint-Paul, La Louviere
country: Belgium
facility: Jolimont
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia
city: Belo Horizonte
country: Brazil
facility: PERSONAL - Oncologia de Precisão 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: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer
city: Florianopolis
country: Brazil
facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
city: Fortaleza
country: Brazil
facility: Suporte Nutricional e Quimioterapia Ltda-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: Fundação São Francisco Xavier
city: Itajai
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
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: Recife
country: Brazil
facility: MultiHemo Servicos Medicos S.A
city: Rio de Janeiro
country: Brazil
facility: Universidade do Estado do Rio de Janeiro - UERJ
city: Rio de Janeiro
country: Brazil
facility: Oncoclínicas 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: Nucleo de Oncologia da Bahia
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
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: 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: Instituto do Cancer Arnaldo Vieira de Carvalho
city: São Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
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: District Oncology Dispensary with In-Patient Stationary - Plovdiv
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: University Health Network (UHN) Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre de Recherche du CHUM
state: Quebec
city: Quebec
country: Canada
facility: Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Naestved
country: Denmark
facility: Næstved Hospital
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besançon
country: France
facility: Centre Hospitalier Regional Universitaire Besancon
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Bérard
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Nice
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 Cancérologie de l'Ouest (ICO)
city: Saint Mande
country: France
facility: HIA Begin
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de Loire
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Strasbourg
country: France
facility: Hôpitaux Universitaire de Strasbourg -CHU
city: Suresnes
country: France
facility: Hopital Foch
city: Tours
country: France
facility: CHRU de Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Bonn
country: Germany
facility: Urologisches Zentrum Bonn
city: Braunschweig
country: Germany
facility: Urologie im Schlosscarree Schreier/Eichler/Junius - Germany
city: Chemnitz
country: Germany
facility: Zeisigwaldkliniken Bethanien Chemnitz
city: Dresden
country: Germany
facility: Urologische Gemeinschaftspraxis Böhm/Linne - Germany
city: Hamburg
country: Germany
facility: uro Eimsbüttel - Gemeinschaftspraxis Bath/Weinzierl
city: Hannover
country: Germany
facility: Klinikum Region Hannover Klinikum Siloah
city: Markkleeberg
country: Germany
facility: Matthias Schulze - Germany
city: Wesseling
country: Germany
facility: CUROS - Uberörtliche urologische Gemeinschaftspraxis
city: Beer-Sheva
country: Israel
facility: Soroka Hospital
city: Haifa
country: Israel
facility: Rambam Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Zrifin
country: Israel
facility: Asaf Harofe Medical Center
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Benevento
country: Italy
facility: Ospedale Sacro Cuore Di Gesu
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Bolzano
country: Italy
facility: Ospedale di Bolzano
city: Brindisi
country: Italy
facility: oncologia medica - Oncology
city: Camposampiero
country: Italy
facility: Azienda Ulss 6 Euganea- Ospedale Di Camposampiero
city: Carrara
country: Italy
facility: Ospedale Di Carrara
city: Caserta
country: Italy
facility: AORN Sant'anna e San Sebastiano
city: Crema
country: Italy
facility: ASST -Ospedale Maggiore di Crema
city: Mirano
country: Italy
facility: Azienda ULSS 3 Serenissima, presidio di Mirano
city: Piombino
country: Italy
facility: PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest
city: Ponderano
country: Italy
facility: Ospedale degli Infermi
city: Ponticelli
country: Italy
facility: Ospedale del Mare ASL Napoli 1 centro
city: Rovigo
country: Italy
facility: Azienda ULSS5 Polesana di Rovigo - Ospedale Santa Maria della Misericordia
city: San Fermo della Battaglia
country: Italy
facility: PO Ospedale S.Anna, ASST Lariana
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: Goyang-Si
country: Korea, Republic of
facility: National Cancer Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University 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
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
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: Delft
country: Netherlands
facility: Renier de Graaf
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
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: Konin
country: Poland
facility: Przychodnia Lekarska KOMED Roman Karaszewski
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
city: Siedlce
country: Poland
facility: Urologica Praktyka Lekarska Adam Marcheluk
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Warszawa
country: Poland
facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
city: Wroclaw
country: Poland
facility: Specjalistyczna przychodnia lekarska POLIMED
city: Barnaul
country: Russian Federation
facility: Altai Regional Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
city: Ivanovo
country: Russian Federation
facility: Ivanovo 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: Moscow
country: Russian Federation
facility: Hertzen Oncology Research Institute
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsky District Medical Centre
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Interdistrict Oncology Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: Saransk
country: Russian Federation
facility: Republican Oncology Dispensary
city: Tyumen
country: Russian Federation
facility: Multifunctional clinical medical center 'Medical city'
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: A Coruña
country: Spain
facility: Hosp. Univ. A Coruna
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp. Clinic de Barcelona
city: Castellon
country: Spain
facility: Hosp. Gral. Univ. de Castellon
city: Girona
country: Spain
facility: Institut Català D'Oncologia Girona
city: Jaén
country: Spain
facility: Hosp. Univ. de Jaen
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Lleida
country: Spain
facility: Hosp. Univ. Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp. Univ. Hm Monteprincipe
city: Madrid
country: Spain
facility: Hosp. Univ. Del Henares
city: Málaga
country: Spain
facility: Hosp. Virgen de La Victoria
city: Ourense
country: Spain
facility: Complexo Hosp. Univ. de Ourense
city: Parla, Madrid
country: Spain
facility: Hosp. Univ. Infanta Cristina
city: Puerto Real, Cádiz
country: Spain
facility: Hosp. Puerto Real
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Tarragona
country: Spain
facility: Hosp. de Sant Pau I Santa Tecla
city: Terrassa
country: Spain
facility: Hosp. de Terrassa
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Malmö
country: Sweden
facility: Skanes universitetssjukhus
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung 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: National Cheng Kung University 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: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Ankara
country: Turkey
facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Bursa
country: Turkey
facility: Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
city: Istanbul
country: Turkey
facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
city: Cherkasy
country: Ukraine
facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
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: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kamianske
country: Ukraine
facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council
city: Khakhiv
country: Ukraine
facility: Municipal non-profit enterprise 'Regional Center of Oncology'
city: Kharkiv
country: Ukraine
facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval
city: Khmelnytsky
country: Ukraine
facility: Khmelnitckiy regional hospital
city: Kropyvnytskyi
country: Ukraine
facility: Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'
city: Kyiv
country: Ukraine
facility: 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: Lviv Clinical Regional 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: Zhytomyr
country: Ukraine
facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: