Clinical trial NCT04464226: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Official title: An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cancer
Keywords: Roll-Over Study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 402
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.


Eligibility criteria: Inclusion Criteria:

* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
* Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
* Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion Criteria:

* Participant is unable to comply with the requirements of the study.
* Negative benefit/ risk ratio as determined by the investigator.
* Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 4 years
measure: Incidence of treatment-emergent serious adverse events (TESAEs)
timeFrame: Up to 4 years
measure: Incidence of drug-related TEAEs
timeFrame: Up to 4 years
measure: Incidence of drug-related TESAEs
timeFrame: Up to 4 years
Secondary outcomes:
measure: Number of dose modifications
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama, PC
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers - Chandler I
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: La Mesa
country: United States
facility: San Diego Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Tower Urology, Inc
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Stanford
country: United States
facility: Stanford Health Care
state: California
city: Whittier
country: United States
facility: TOI Clinical Research
state: California
city: Aurora
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: Denver
country: United States
facility: The Urology Center Of Colorado
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital - Oncology
state: Florida
city: Orlando
country: United States
facility: Advent Health Medical Group Urology
state: Florida
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center - Cardiology
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare - Peoria
state: Illinois
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute - Downtown
state: Kentucky
city: Annapolis
country: United States
facility: Anne Arundel Health System
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Urology Associates - Towson
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital - Pulmonology
state: Maryland
city: Salisbury
country: United States
facility: TidalHealth Peninsula Regional, Inc.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital - OB/GYN
state: Michigan
city: Billings
country: United States
facility: St. Vincent Hospital & Healthcare
state: Montana
city: Omaha
country: United States
facility: Urology Cancer Center, PC
state: Nebraska
city: Omaha
country: United States
facility: XCancer Omaha
state: Nebraska
city: Voorhees
country: United States
facility: New Jersey Urology - Voorhees
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Cancer Center - Albuquerque
state: New Mexico
city: Bronx
country: United States
facility: New York Cancer & Blood Specialists - Eastchester
state: New York
city: Bronx
country: United States
facility: Montefiore Einstein Center for Cancer Care
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute
state: Ohio
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology - Bala Cynwyd
state: Pennsylvania
city: Camp Hill
country: United States
facility: Andrews & Patel Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology - Downtown
state: South Carolina
city: Greenville
country: United States
facility: Bon Secours St. Francis Hospital
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urological Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates, PC
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute- Salt Lake City
state: Utah
city: Fairfax
country: United States
facility: Inova Schar Cancer Insitute - Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro de Urología
state: Ciudad Auton. De Buenos Aires
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre Research Pty Ltd
state: South Australia
city: Wien
country: Austria
facility: Universitätsklinikum AKH Wien
city: Lesnoy
country: Belarus
facility: N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department
city: Minsk
country: Belarus
facility: Minsk City Clinical Oncological Dispensary - Oncology Department
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen
state: Antwerpen
city: Bruxelles - Brussel
country: Belgium
facility: CU Saint-Luc/UZ St-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan
city: Liege
country: Belgium
facility: CHU de Liège
city: Namur
country: Belgium
facility: CHU UCL Namur
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
city: Salvador
country: Brazil
facility: Santa Casa de Misericórdia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceará
state: Ceará
city: Cachoeiro de Itapemirim
country: Brazil
facility: Hospital Evangélico de Cachoeiro de Itapemirim
state: Espírito Santo
city: Goiânia
country: Brazil
facility: Hosp. Araujo Jorge da Associação de Combate ao Câncer
state: Goiás
city: Uberlandia
country: Brazil
facility: COT Centro Oncologico do Triangulo Ltda
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
state: Rio Grande Do Norte
city: Passo Fundo
country: Brazil
facility: Associação Hospitalar Beneficente São Vicente de Paulo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda
state: Santa Catarina
city: Barretos/SP
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: Sao Paulo
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IEP São Lucas
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Cancer
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Inst. de Assistência Médica ao Sérvidor Público Estadual
state: Sao Paulo
city: Sofia
country: Bulgaria
facility: Medical Center Kalimat
city: Vratsa
country: Bulgaria
facility: Complex Oncology Center - Vratsa
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine Professional Corporation
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital-University Health Network
state: Ontario
city: Granby
country: Canada
facility: CIUSSS de l'Estrie- Centre Haute-Yamaska
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopi
state: Quebec
city: Hefei City, Anhui Province
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui medical university
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Shantou
country: China
facility: 2nd Affiliated Hosp. of Shantou University Medical College
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nantong
country: China
facility: Nantong tumor hospital
state: Jiangsu
city: Suzhou
country: China
facility: The 2nd Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
state: Jiangxi
city: Changchun City
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shengyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hosp., Shandong Univ.
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Medical University - First Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan University West China Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan University West China Hospital
state: Sichuan
city: Hangzhou
country: China
facility: ZheJiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Ningbo
country: China
facility: Ningbo First Hospital
city: Shandong
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Shanghai
country: China
facility: Huadong Hospital, Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Zhejiang
country: China
facility: ZheJiang Provincial People's Hospital
city: Medellin
country: Colombia
facility: Hospital Pablo Tobón Uribe
state: Antioquia
city: Montería
country: Colombia
facility: Oncomédica S.A.
state: Córdoba
city: Florida Blanca
country: Colombia
facility: Fundación Oftalmológica de Santander Carlos Ardila Lule
state: Santander
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Jablonec nad Nisou
country: Czechia
facility: Nemocnice Jablonec nad Nisou
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Urocentrum Praha, s.r.o.
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Praha 6
country: Czechia
facility: ANDROGEOS, spol. s r.o.
city: Tallinn
country: Estonia
facility: Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinik
city: Helsinki
country: Finland
facility: HUS, Meilahden sairaala
state: Uusimaa
city: Jyväskylä
country: Finland
facility: Keski-Suomen sairaala Nova
city: Mikkeli
country: Finland
facility: Mikkelin keskussairaala
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
city: Seinäjoki
country: Finland
facility: Seinäjoen keskussairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Angers
country: France
facility: Centre Hospitalier Universitaire - Angers
city: Bordeaux
country: France
facility: Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
city: Brest
country: France
facility: Clinique Lanroze
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre d'Oncologie et de Radiologie du Parc
city: Marseille
country: France
facility: Institut Paoli-Calmettes - Marseille
city: Montpellier Cedex
country: France
facility: ICM - Institut du Cancer de Montpellier - Val d'Aurelle
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly
city: Nantes
country: France
facility: Hopital Hotel Dieu - Nantes
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre Benite
country: France
facility: HCL - Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Hôpital de la Milétrie
city: Reims
country: France
facility: Institut de Cancerologie Jean Godinot
city: Rennes Cedex
country: France
facility: CHU Rennes - Hopital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint Mande
country: France
facility: Hôpital d'Instruction des Armées Begin
city: Saint-Herblain
country: France
facility: Institut de Cancerologie Ouest - Saint-Herblain
city: Suresnes
country: France
facility: Centre Médico-Chirurgical Foch
city: Tours
country: France
facility: Hopital Bretonneau
city: Villejuif Cedex
country: France
facility: Gustave Roussy - Departement Oncologie-Radiotherapie
city: Emmendingen
country: Germany
facility: Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger
state: Baden-Württemberg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Kirchheim unter Teck
country: Germany
facility: Urologische GemPraxis Dr. R. Rudolph
state: Baden-Württemberg
city: Muehlacker
country: Germany
facility: Urologische Gemeinschaftspraxis Muehlacker
state: Baden-Württemberg
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
state: Baden-Württemberg
city: Reutlingen
country: Germany
facility: Urologische Gemeinschaftspraxis Dr. Simone Maier
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Uniklinik Tübingen / Urologie
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum der Johann Wolfgang Goethe Universität
state: Hessen
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
state: Niedersachsen
city: Holzminden
country: Germany
facility: Gesundheitszentrum Holzminden
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität Düsseldorf
state: Nordrhein-Westfalen
city: Mühlheim
country: Germany
facility: Praxis Drs. Tim Schneider /B. Schneider
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: Medizinische Fakultät der Otto-von-Guericke Universität
state: Sachsen-Anhalt
city: Jena
country: Germany
facility: Friedrich-Schiller-Uni. Jena
state: Thuringen
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Szekszard
country: Hungary
facility: Tolna Varmegyei Balassa Janos Korhaz
city: Zalaegerszeg
country: Hungary
facility: Zala Varmegyei Szent Rafael Korhaz
city: Beer Sheva
country: Israel
facility: Clalit Health | Soroka Medical Center - Internal Medicine Department
city: Petach Tikva
country: Israel
facility: Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
city: Zefat
country: Israel
facility: Health Corporation of the Ziv Medical Center (R.A.)
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale
state: Campania
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria Parma
state: Emilia-Romagna
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
state: Piemonte
city: Torino
country: Italy
facility: Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
state: Piemonte
city: Padova
country: Italy
facility: Istituto Oncologico Veneto_Padova - UOC Oncologia 1
state: Veneto
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Asahi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Higashiibaraki
country: Japan
facility: National hospital Organization Mito Medical Center
state: Ibaraki
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Ueda
country: Japan
facility: National Hospital Organization Shinshu Ueda Medical Center
state: Nagano
city: Yufu
country: Japan
facility: Oita University Hospital
state: Oita
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Sayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita
country: Japan
facility: The University of Osaka Hospital
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Saiseikai Utsunomiya Hospital
state: Tochigi
city: Bunkyo-Ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Tokyo Metropolitan Institute for Geriatrics and Gerontology
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Nakano-ku
country: Japan
facility: Tokyo Metropolitan Police Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Sumida-ku
country: Japan
facility: The Fraternity Memorial Hospital
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbugdo
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Gwangju Gwang''yeogsi
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
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: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital "Gailezers"
city: Kaunas
country: Lithuania
facility: Hospital of LT University of Health Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Monterrey
country: Mexico
facility: Hospital Universitario "José Eleuterio González"
state: Nuevo Leon
city: Santiago de Querétaro
country: Mexico
facility: INBIOMEDyC Querétaro
state: Querétaro
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
city: Geleen
country: Netherlands
facility: Zuyderland Medical Centre | Internal Medicine Department
city: Hilversum
country: Netherlands
facility: Tergooi MC | Hilversum - Wetenschapsbureau
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Tilburg
country: Netherlands
facility: ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)
city: La Victoria
country: Peru
facility: Centro Médico Monte Carmelo - Oncology Department
state: Arequipa
city: Lima
country: Peru
facility: Hospital Central de la Fuerza Aerea del Perú
city: Lima
country: Peru
facility: Instituto Peruano de Oncología & Radioterapia - Oncologia SA - Oncology Department
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lodz
country: Poland
facility: ETG Network Spolka z o.o.
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
city: Siedlce
country: Poland
facility: Urologica Praktyka Lekarska Adam Marcheluk
city: Waliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Szpital Grochowski im. dr.med. Rafala Masztaka
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny SA
city: Matosinhos
country: Portugal
facility: ULSM - Hospital Pedro Hispano
state: Porto
city: Almada
country: Portugal
facility: Hospital Garcia de Orta | Research Department
state: Setúbal
city: Lisboa
country: Portugal
facility: IPO Lisboa
city: Lisboa
country: Portugal
facility: CHLC - Hospital Sao Jose
city: Lisboa
country: Portugal
facility: Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
city: Porto
country: Portugal
facility: IPO Porto
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Craiova
country: Romania
facility: Sf. Nectarie Oncology Center
city: Oradea
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Oradea
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Chelyabinsk
country: Russian Federation
facility: Ltd "EVIMED"
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Oncology Dispensary
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary Kazan
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
city: Moscow
country: Russian Federation
facility: Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
city: Moscow
country: Russian Federation
facility: City clinical hospital #40 Moscow
city: Nizhny Novgorod
country: Russian Federation
facility: City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.
city: Novosibirsk
country: Russian Federation
facility: LLC Reafan
city: Novosibirsk
country: Russian Federation
facility: Medical Center "Avicenna"
city: Obninsk
country: Russian Federation
facility: National Medical Research Radiology Center
city: Omsk
country: Russian Federation
facility: Clinical Oncological Dispensary of Omsk Region
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Hospital of RAS
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Medical University n.a. I.P. Pavlov
city: Tyumen
country: Russian Federation
facility: Multi-Field Clinical Medical Center "Medical City"
city: Vladimir
country: Russian Federation
facility: Regional Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska kosa
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Bratislava
country: Slovakia
facility: J. BREZA MEDICAL s. r. o.
city: Bratislava
country: Slovakia
facility: CUIMED s.r.o
city: Trencin
country: Slovakia
facility: Privatna urologicka ambulancia, s.r.o.
city: George
country: South Africa
facility: Cancercare Outeniqua
state: Eastern Cape
city: Cape Town
country: South Africa
facility: Dept Radiation and Oncology Tygerberg Academic Hospital
state: Western Cape
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology
state: Western Cape
city: Elche
country: Spain
facility: Hospital General de Elche
state: Alicante
city: Sabadell
country: Spain
facility: Parc Tauli Hospital Universitari - Oncologia
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital SAS de Jerez de la Frontera
state: Cádiz
city: Manacor
country: Spain
facility: Hospital de Manacor
state: Illes Baleares
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases - Oncologia
state: Illes Baleares
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon - Urologia
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i de Sant Pau | Oncología
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge (HUB)
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Lugo
country: Spain
facility: Hospital Lucus Augustí
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon | Oncologia
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal | Oncología
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos | Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria | Oncology
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Sevilla
country: Spain
facility: H Virgen del Rocio |Cardiology|AF|Stroke prevention
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova de Valencia
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus Malmö
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus, Umea
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
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 at Linkou
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
city: Cherkasy
country: Ukraine
facility: CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
city: Chernivtsi
country: Ukraine
facility: Regional communal non-profit enterprise 'Chernivtsi regional clinical hospital' - Urological department
city: Dnipro
country: Ukraine
facility: Municipal Non-commercial Enterprise 'City Clinical Hospital #4' of Dnipro City Council - City ?hemotherapy ?enter
city: Kharkiv
country: Ukraine
facility: Regional Medical Clinical Center of Urology and Nephrology n.a. V. I. Shapoval - Department of Oncologic Urology #5
city: Kyiv
country: Ukraine
facility: Kyiv City Hospital #3 - Department of Urology
city: Kyiv
country: Ukraine
facility: SE "Academician O.F. Vozianov Institute of Urology" of NAMSU - Division of Reconstructive Urology and Advanced Technologies
city: Uzhgorod
country: Ukraine
facility: Transkarpathian Regional Oncology Center
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology
state: Berkshire
city: Llanelli
country: United Kingdom
facility: Prince Philip Hospital
state: Carmarthenshire
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust¦Colchester General Hospital - Oncology Trials Unit
state: Essex
city: Bebington
country: United Kingdom
facility: Clatterbridge Centre for Oncology
state: Merseyside
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
state: North East Lincolnshire
city: Dudley
country: United Kingdom
facility: Dudley Group NHS Foundation Trust ¦Russells Hall Hopsital - Oncology
state: West Midlands
city: Huddersfield
country: United Kingdom
facility: Calderdale and Huddersfield NHS Foundation Trust¦Huddersfield Royal Infirmary - Oncology
state: West Yorkshire
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Teaching NHS Trust¦Pinderfields Hospital - Oncology
state: West Yorkshire
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
References: