- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04464226
Studie for å fortsette behandling med Darolutamid hos pasienter som har deltatt i tidligere Darolutamid-studier støttet av Bayer
En åpen-label, enkeltarms, roll-over-studie for å gi fortsatt behandling med darolutamid hos deltakere som ble registrert i tidligere Bayer-sponsede studier
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Ciudad Auton. de Buenos Aires
-
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1120AAT
- Centro de Urología
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-
-
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Adelaide Cancer Centre Research Pty Ltd
-
-
-
-
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Kortrijk, Belgia, 8500
- AZ Groeninge Campus Kennedylaan
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Liège, Belgia, 4000
- CHU de Liège
-
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Antwerpen
-
Wilrijk, Antwerpen, Belgia, 2610
- GZA Ziekenhuizen
-
-
-
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Ceará
-
Fortaleza, Ceará, Brasil, 60430-230
- Instituto do Câncer do Ceará
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brasil, 29308-020
- Hospital Evangelico de Cachoeiro de Itapemirim
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Goiás
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Goiânia, Goiás, Brasil, 74605-070
- Hosp. Araujo Jorge da Associação de Combate ao Câncer
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Goiânia, Goiás, Brasil, 88301-220
- Clinica de Neoplasias Litoral Ltda
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Minas Gerais
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Uberlândia, Minas Gerais, Brasil, 38408-150
- COT Centro Oncologico do Triangulo Ltda
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Paraná
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Curitiba, Paraná, Brasil, 81520-060
- Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59040-000
- Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, Brasil, 99010-080
- Associação Hospitalar Beneficente São Vicente de Paulo
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São Paulo
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Barretos, São Paulo, Brasil, 14784-400
- Fundação Pio XII - Hospital de Câncer de Barretos
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Jaú, São Paulo, Brasil, 17210-120
- Hospital Amaral Carvalho
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Jaú, São Paulo, Brasil, 03102-002
- IBCC - Instituto Brasileiro de Controle do Cancer
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Ribeirão Preto, São Paulo, Brasil, 14051-140
- Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
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São Paulo, São Paulo, Brasil, 01246-000
- Instituto do Cancer do Estado de São Paulo
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São Paulo, São Paulo, Brasil, 41253-190
- Hospital Sao Rafael
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São Paulo, São Paulo, Brasil, 50040-410
- Santa Casa de Misericórdia da Bahia
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São Paulo, São Paulo, Brasil, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
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São Paulo, São Paulo, Brasil, 90619-900
- União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS
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Sofia City Province
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Sofia, Sofia City Province, Bulgaria, 1680
- Medical Center Kalimat
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Vratsa Province
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Vratsa, Vratsa Province, Bulgaria, 3000
- Complex Oncology Center - Vratsa
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-
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Alberta
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Calgary, Alberta, Canada, T2V 1P9
- Prostate Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- Nova Scotia Health Authority
-
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Ontario
-
Burlington, Ontario, Canada, L7N 3V2
- G. Kenneth Jansz Medicine Professional Corporation
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London, Ontario, Canada, N5R 6M6
- London Health Sciences Centre
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital-University Health Network
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Quebec
-
Granby, Quebec, Canada, J2G 1T7
- Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology
-
Montreal, Quebec, Canada, H2X 0C1
- Centre Hospitalier de l'Universite de Montreal (CHUM) | Oncology
-
-
-
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Antioquia
-
Medellín, Antioquia, Colombia, 050034
- Hospital Pablo Tobon Uribe
-
-
Departamento de Córdoba
-
Montería, Departamento de Córdoba, Colombia, 230002
- Oncomedica S.A.
-
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Santander Department
-
Floridablanca, Santander Department, Colombia, 681004
- Fundación Oftalmológica de Santander Carlos Ardila Lule
-
-
-
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Harju
-
Tallinn, Harju, Estland, 13419
- Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinik
-
-
-
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Central Finland
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Jyväskylä, Central Finland, Finland, 40620
- Keski-Suomen sairaala Nova
-
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North Ostrobothnia
-
Oulu, North Ostrobothnia, Finland, 90220
- Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)
-
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Pirkanmaa
-
Tampere, Pirkanmaa, Finland, 33520
- Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)
-
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South Ostrobothnia
-
Seinäjoki, South Ostrobothnia, Finland, 60220
- Seinäjoen keskussairaala
-
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South Savo
-
Mikkeli, South Savo, Finland, 50100
- Mikkelin keskussairaala
-
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Southwest Finland
-
Turku, Southwest Finland, Finland, 20520
- Turun yliopistollinen keskussairaala
-
-
Uusimaa
-
Helsinki, Uusimaa, Finland, 00029
- HUS, Meilahden sairaala
-
-
-
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Alabama
-
Homewood, Alabama, Forente stater, 35209
- Urology Centers of Alabama, PC - Homewood
-
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Arizona
-
Chandler, Arizona, Forente stater, 85224
- Ironwood Cancer and Research Centers - Chandler I
-
-
California
-
Los Angeles, California, Forente stater, 90048
- Tower Urology
-
Palo Alto, California, Forente stater, 94304
- Stanford Cancer Center Palo Alto
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San Diego, California, Forente stater, 92120
- San Diego Clinical Trials
-
Whittier, California, Forente stater, 90603
- TOI Clinical Research
-
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Colorado
-
Aurora, Colorado, Forente stater, 80045
- Rocky Mountain Regional VA Medical Center - Oncology
-
Denver, Colorado, Forente stater, 80211
- The Urology Center of Colorado
-
-
Florida
-
Boca Raton, Florida, Forente stater, 33486
- Boca Raton Regional Hospital - Oncology
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60612
- Jesse Brown VA Medical Center - Cardiology
-
Peoria, Illinois, Forente stater, 61615
- Illinois CancerCare - Peoria
-
-
Kentucky
-
Louisville, Kentucky, Forente stater, 40202
- Norton Cancer Institute - Downtown
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21204
- Chesapeake Urology Associates - Towson
-
Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins Hospital - Pulmonology
-
Salisbury, Maryland, Forente stater, 21801
- TidalHealth Peninsula Regional, Inc. - Oncology
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital - OB/GYN
-
-
Montana
-
Billings, Montana, Forente stater, 59102
- St. Vincent Regional Hospital - Oncology
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68130
- XCancer Omaha
-
-
New Jersey
-
Voorhees Township, New Jersey, Forente stater, 08043
- New Jersey Urology - Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87109
- New Mexico Cancer Center - Albuquerque
-
-
New York
-
Rochester, New York, Forente stater, 14642
- URMC Wilmot Cancer Center
-
The Bronx, New York, Forente stater, 10469
- New York Cancer & Blood Specialists - Eastchester
-
The Bronx, New York, Forente stater, 14061
- Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park
-
-
Ohio
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Canton, Ohio, Forente stater, 44718
- Gabrail Cancer Center
-
Cincinnati, Ohio, Forente stater, 45212
- The Urology Group - Norwood Surgery Center
-
Columbus, Ohio, Forente stater, 43210
- The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute
-
-
Pennsylvania
-
Bala-Cynwyd, Pennsylvania, Forente stater, 19004
- MidLantic Urology - Bala Cynwyd
-
Camp Hill, Pennsylvania, Forente stater, 17011
- Andrews & Patel Associates
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29403
- Charleston Oncology - Downtown
-
Myrtle Beach, South Carolina, Forente stater, 29579
- Carolina Urological Research Center
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37209
- Urology Associates, PC - Nashville
-
-
Texas
-
Dallas, Texas, Forente stater, 75231
- Urology Clinics of North Texas - Dallas (Walnut HIll Lane)
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute
-
-
Virginia
-
Richmond, Virginia, Forente stater, 23284
- VCU Health Ambulatory Care Center - Cardiology
-
-
Washington
-
Everett, Washington, Forente stater, 98201
- Providence Regional Cancer Partnership
-
Fairfax, Washington, Forente stater, 22031
- Inova Schar Cancer Insitute - Inova Fairfax Hospital
-
-
-
-
Auvergne-Rhône-Alpes
-
Clermont-Ferrand, Auvergne-Rhône-Alpes, Frankrike, 63011
- Centre Jean Perrin
-
Pierre-Bénite, Auvergne-Rhône-Alpes, Frankrike, 69495
- HCL - Centre Hospitalier Lyon Sud
-
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Bourgogne-Franche-Comté
-
Dijon, Bourgogne-Franche-Comté, Frankrike, 21000
- Centre d'Oncologie et de Radiologie du Parc
-
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Brittany Region
-
Brest, Brittany Region, Frankrike, 29200
- Clinique Lanroze
-
Rennes, Brittany Region, Frankrike, 35033
- CHU Rennes - Hopital Pontchaillou
-
-
Centre-Val de Loire
-
Tours, Centre-Val de Loire, Frankrike, 37044
- CHU Tours - Hôpital BRETONNEAU
-
-
Grand Est
-
Reims, Grand Est, Frankrike, 51056
- Institut de Cancerologie Jean Godinot - Departement oncologie medicale
-
-
Normandy
-
Rouen, Normandy, Frankrike, 76031
- Hôpital Charles Nicolle
-
-
Nouvelle-Aquitaine
-
Bordeaux, Nouvelle-Aquitaine, Frankrike, 33000
- Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
-
Poitiers, Nouvelle-Aquitaine, Frankrike, 86021
- Hôpital de la Milétrie
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Occitanie
-
Montpellier, Occitanie, Frankrike, 34298
- ICM - Institut du Cancer de Montpellier - Val d'Aurelle
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Pays de la Loire Region
-
Angers, Pays de la Loire Region, Frankrike, 49933
- Centre Hospitalier Universitaire - Angers
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Nantes, Pays de la Loire Region, Frankrike, 44000
- Hopital Hotel Dieu - Nantes
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Saint-Herblain, Pays de la Loire Region, Frankrike, 44800
- Institut de Cancerologie Ouest - Saint-Herblain
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Provence-Alpes-Côte d'Azur Region
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Marseille, Provence-Alpes-Côte d'Azur Region, Frankrike, 13273
- Institut Paoli-Calmettes - Marseille
-
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Île-de-France Region
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Paris, Île-de-France Region, Frankrike, 75010
- Hopital Saint Louis
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Saint-Mandé, Île-de-France Region, Frankrike, 94160
- Hopital d'Instruction des Armees BEGIN
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Suresnes, Île-de-France Region, Frankrike, 92151
- Centre Médico-Chirurgical Foch
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Villejuif, Île-de-France Region, Frankrike, 94805
- Gustave Roussy - Departement Oncologie-Radiotherapie
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-
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Minsk Oblast
-
Lyasny, Minsk Oblast, Hviterussland, 223040
- N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department
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Minsk, Minsk Oblast, Hviterussland, 220013
- Minsk City Clinical Oncological Dispensary - Oncology Department
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-
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-
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Beersheba, Israel, 8410101
- Clalit Health | Soroka Medical Center - Internal Medicine Department
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Petah Tikva, Israel, 4941492
- Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
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Safed, Israel, 1311001
- Health Corporation of the Ziv Medical Center (R.A.)
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-
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Campania
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Naples, Campania, Italia, 80131
- Irccs Istituto Nazionale Tumori Fondazione Pascale
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Emilia-Romagna
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Parma, Emilia-Romagna, Italia, 43126
- Azienda Ospedaliero Universitaria Parma
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Piedmont
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Orbassano, Piedmont, Italia, 10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
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Turin, Piedmont, Italia, 10060
- Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
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Veneto
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Padova, Veneto, Italia, 35128
- Istituto Oncologico Veneto_Padova - UOC Oncologia 1
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-
-
-
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Chiba, Japan, 260-8717
- Chiba Cancer Center
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Gifu, Japan, 500-8717
- Gifu Prefectural General Medical Center
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Hiroshima, Japan, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Kumamoto, Japan, 860-0008
- National Hospital Organization Kumamoto Medical Center
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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Osaka, Japan, 558-8558
- Osaka General Medical Center
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Toyama, Japan, 930-0194
- Toyama University Hospital
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Wakayama, Japan, 640-8558
- Wakayama Medical University Hospital
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-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 466-8560
- Nagoya University Hospital
-
-
Chiba
-
Asahi, Chiba, Japan, 289-2511
- Asahi General Hospital
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Sakura, Chiba, Japan, 285-8741
- Toho University Sakura Medical Center
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Gunma
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Maebashi, Gunma, Japan, 371-8511
- Gunma University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8543
- Sapporo Medical University Hospital
-
-
Hyōgo
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Kobe, Hyōgo, Japan, 650-0017
- Kobe University Hospital
-
-
Ibaraki
-
Higashiibaraki, Ibaraki, Japan, 311-3193
- National Hospital Organization Mito Medical Center
-
-
Kanagawa
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Sagamihara, Kanagawa, Japan, 252-0375
- Kitasato University Hospital
-
Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center
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Yokosuka, Kanagawa, Japan, 238-8558
- Yokosuka Kyosai Hospital
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-
Mie-ken
-
Tsu, Mie-ken, Japan, 514-8507
- Mie University Hospital
-
-
Nagano
-
Ueda, Nagano, Japan, 386-8610
- National Hospital Organization Shinshu Ueda Medical Center
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Oita Prefecture
-
Yufu, Oita Prefecture, Japan, 879-5593
- Oita University Hospital
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Osaka
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Osaka, Osaka, Japan, 541-8567
- Osaka International Cancer Institute
-
Sakai, Osaka, Japan, 590-0197
- Kindai University Hospital
-
Suita, Osaka, Japan, 565-0871
- The University of Osaka Hospital
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Shizuoka
-
Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University Hospital
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Tochigi
-
Utsunomiya, Tochigi, Japan, 321-0974
- Saiseikai Utsunomiya Hospital
-
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Tokyo
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Bunkyo-Ku, Tokyo, Japan, 113-0022
- Nippon Medical School Hospital
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Itabashi-ku, Tokyo, Japan, 173-0015
- Tokyo Metropolitan Institute for Geriatrics and Gerontology
-
Mitaka, Tokyo, Japan, 181-8611
- Kyorin University Hospital
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Nakano-ku, Tokyo, Japan, 164-8541
- Tokyo Metropolitan Police Hospital
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Keio University Hospital
-
Sumida-ku, Tokyo, Japan, 130-8587
- The Fraternity Memorial Hospital
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Tottori
-
Yonago, Tottori, Japan, 683-8504
- Tottori University Hospital
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Yamaguchi
-
Ube, Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital
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-
-
-
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Beijing, Kina, 100083
- Peking University Third Hospital
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Beijing, Kina, 100000
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Chengdu, Kina, 610072
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
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Chongqing, Kina, 400030
- Chongqing Cancer Hospital
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Guangzhou, Kina, 510000
- Sun yat-sen University Cancer Center
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Ningbo, Kina, 315010
- Ningbo First Hospital
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Shandong, Kina, 266000
- The Affiliated Hospital of Qingdao University
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Shanghai, Kina, 200032
- Zhongshan Hospital, Fudan University
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Shanghai, Kina, 200080
- Shanghai General Hospital
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Shanghai, Kina, 200040
- Huadong Hospital, Affiliated to Fudan University
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Shanghai, Kina, 200000
- Fudan University Shanghai Cancer Center - Oncology Department
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Shanghai, Kina, 200025
- Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
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Shenzhen, Kina, 518172
- Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
-
Tianjin, Kina, 300211
- The Second Hospital Of Tianjin Medical University
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Tianjin, Kina, 300000
- Tianjin Medical University Cancer Institute & Hospital
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Zhejiang, Kina, 314408
- Zhejiang Provincial People's Hospital
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Anhui
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Hefei, Anhui, Kina, 230601
- The Second Affiliated Hospital of Anhui Medical University
-
Hefei City, Anhui Province, Anhui, Kina, 230031
- Anhui Provincial Hospital
-
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Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Beijing Hospital
-
Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital - Oncology Department
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350005
- The First Affiliated Hospital of Fujian Medical University
-
Xiamen, Fujian, Kina, 361003
- The First Affiliated Hospital of Xiamen University
-
-
Guangdong
-
Shantou, Guangdong, Kina, 515021
- 2nd Affiliated Hosp. of Shantou University Medical College
-
-
Hubei
-
Wuhan, Hubei, Kina, 430030
- Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
-
Wuhan, Hubei, Kina, 430079
- Hubei Cancer Hospital
-
-
Hunan
-
Changsha, Hunan, Kina, 410013
- Hunan Cancer Hospital - Oncology Department
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210029
- The First Affiliated Hospital of Nanjing Medical University
-
Nanjing, Jiangsu, Kina, 210008
- NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
-
Nanjing, Jiangsu, Kina, 210000
- Jiangsu Cancer Hospital
-
Nantong, Jiangsu, Kina, 226361
- Nantong Tumor Hospital
-
Suzhou, Jiangsu, Kina, 215004
- The 2nd Affiliated Hospital of Soochow University
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- The First Affiliated Hospital of Nanchang University
-
-
Jilin
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Changchun, Jilin, Kina, 130061
- The First Hospital of Jilin University
-
-
Liaoning
-
Shengyang, Liaoning, Kina, 110042
- Liaoning Cancer Hospital and Institute
-
-
Shandong
-
Jinan, Shandong, Kina, 250012
- Qilu Hosp., Shandong Univ.
-
Yantai, Shandong, Kina, 264000
- Yantai Yuhuangding Hospital
-
-
Shanxi
-
Taiyuan, Shanxi, Kina, TBC
- Shanxi Medical University - First Hospital
-
Xi’an, Shanxi, Kina, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Sichuan
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Chengdu, Sichuan, Kina, 610041
- Sichuan University West China Hospital
-
Chengdu, Sichuan, Kina, 610041
- University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310014
- Zhejiang Provincial People's Hospital
-
Wenzhou, Zhejiang, Kina, 325000
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
Daugavpils City
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Daugavpils, Daugavpils City, Latvia, LV-5417
- Daugavpils Regional Hospital
-
-
Liepaja City
-
Liepāja, Liepaja City, Latvia, LV-3401
- Litavniece Dzintra practice in urology and oncological chem.
-
-
Riga City
-
Riga, Riga City, Latvia, LV-1002
- P. Stradins Clinical University Hospital
-
Riga, Riga City, Latvia, LV-1029
- AS "Association of Health Centers" polyclinic "Elite"
-
Riga, Riga City, Latvia, LV-1038
- Riga East Clinical University Hospital "Gailezers"
-
-
Valmiera City
-
Valmiera, Valmiera City, Latvia, LV-4201
- Vidzemes Hospital
-
-
-
-
-
Kaunas, Litauen, LT-50161
- Hospital of LT University of Health Sciences Kaunas Clinics
-
Klaipėda, Litauen, LT-92288
- PI Klaipedos University Hospital
-
Vilnius, Litauen, LT-08660
- National Cancer Institute
-
Vilnius, Litauen, LT-08661
- Vilnius University Hospital Santaros Klinikos
-
-
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario "José Eleuterio González"
-
-
Querétaro
-
Querétaro City, Querétaro, Mexico, 76000
- INBIOMEDyC Querétaro
-
-
-
-
Limburg
-
Geleen, Limburg, Nederland, 6162 BG
- Zuyderland Medical Centre | Internal Medicine Department
-
-
North Brabant
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Tilburg, North Brabant, Nederland, 5042 AD
- ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)
-
-
North Holland
-
Amsterdam, North Holland, Nederland, 1105 AZ
- Academisch Medisch Centrum (AMC)
-
Hilversum, North Holland, Nederland, 1213 VG
- Tergooi MC | Hilversum - Wetenschapsbureau
-
Hoofddorp, North Holland, Nederland, 2134 TM
- Spaarne Gasthuis
-
-
South Holland
-
Dordrecht, South Holland, Nederland, 3318 AT
- Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
-
The Hague, South Holland, Nederland, 2545 CH
- Hagaziekenhuis
-
-
-
-
Lima Province (Provincia de Lima)
-
La Victoria, Lima Province (Provincia de Lima), Peru, 15036
- Centro Médico Monte Carmelo - Oncology Department
-
Lima, Lima Province (Provincia de Lima), Peru, 15036
- Instituto Peruano de Oncología & Radioterapia - Oncologia SA - Oncology Department
-
Lima, Lima Province (Provincia de Lima), Peru, 15046
- Hospital Central de la Fuerza Aerea del Peru
-
-
-
-
-
Lodz, Polen, 90-302
- ETG Network Spolka z o.o.
-
Lublin, Polen, 20-362
- KO-MED Centra Kliniczne Lublin II
-
Otwock, Polen, 05-400
- Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
-
Siedlce, Polen, 08-110
- Urologica Praktyka Lekarska Adam Marcheluk
-
Warsaw, Polen, 04-073
- Szpital Grochowski im. dr.med. Rafala Masztaka
-
-
-
-
-
Lisbon, Portugal, 1099-023
- Ipo Lisboa
-
Lisbon, Portugal, 1500-650
- Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
-
Lisbon, Portugal, 1150-199
- CHLC - Hospital Sao Jose
-
Porto, Portugal, 4200-072
- IPO Porto
-
Porto, Portugal, 4200-319
- Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Urologia
-
-
Setúbal District
-
Almada, Setúbal District, Portugal, 2805-267
- Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
-
-
-
-
-
Bucharest, Romania, 22328
- Institutul Clinic Fundeni, sectia Nefrologie Clinica
-
-
Mure?
-
Târgu Mureş, Mure?, Romania, 540103
- Spitalul Clinic Judetean Mures
-
-
-
-
-
Chelyabinsk, Russland, 454087
- Chelyabinsk Regional Oncology Dispensary
-
Chelyabinsk, Russland, 454048
- Ltd "EVIMED"
-
Ivanovo, Russland, 153040
- Ivanovo Regional Oncology Dispensary
-
Kazan', Russland, 420029
- Republican Clinical Oncology Dispensary Kazan
-
Krasnoyarsk, Russland, 660133
- Krasnoyarsk Regional Clinical Oncology Dispensary
-
Moscow, Russland, 115478
- Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
-
Moscow, Russland, 125284
- Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
-
Nizhny Novgorod, Russland, 603001
- City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.
-
Novosibirsk, Russland, 630099
- LLC Reafan
-
Novosibirsk, Russland, 630099
- Medical Center "Avicenna"
-
Obninsk, Russland, 249036
- National Medical Research Radiology Center
-
Omsk, Russland, 644013
- Clinical Oncological Dispensary of Omsk Region
-
Saint Petersburg, Russland, 188663
- Leningrad Regional Oncology Dispensary
-
Saratov, Russland, 410054
- Saratov State Medical University
-
Tyumen, Russland, 625041
- Multi-Field Clinical Medical Center "Medical City"
-
Vladimir, Russland, 600009
- Regional Clinical Oncology Dispensary
-
-
-
-
-
Belgrade, Serbia, 11080
- Clinical Hospital Center Bezanijska Kosa
-
Niš, Serbia, 18000
- Clinical Center Nis
-
-
-
-
-
Bratislava, Slovakia, 851 01
- J. BREZA MEDICAL s. r. o.
-
Bratislava, Slovakia, 85101
- CUIMED s.r.o
-
-
-
-
-
Barcelona, Spania, 08035
- Hospital Universitari Vall D Hebron | Oncologia
-
Barcelona, Spania, 8041
- Hospital De La Santa Creu I Sant Pau | Oncologia
-
Barcelona, Spania, 8036
- Hospital Clinic De Barcelona | Urologia
-
Barcelona, Spania, 08003
- Hospital del Mar I Oncologia
-
Barcelona, Spania, 8908
- Bellvitge Hospital Universitari | Urologia
-
Cáceres, Spania, 10003
- Hospital San Pedro De Alcantara | Oncologia
-
Córdoba, Spania, 14004
- Hospital Universitario Reina Sofia | Oncologia
-
Lugo, Spania, 27003
- Hospital Universitario Lucus Augusti | Urologia
-
Madrid, Spania, 28009
- Hospital General Universitario Gregorio Maranon | Urologia
-
Madrid, Spania, 28034
- Hospital Universitario Ramon Y Cajal | Oncologia
-
Madrid, Spania, 28040
- Hospital Clinico San Carlos | Oncologia
-
Madrid, Spania, 28040
- Hospital Universitario Fundacion Jimenez Diaz | Urologia
-
Madrid, Spania, 28041
- Hospital Universitario 12 De Octubre | Urologia
-
Málaga, Spania, 29010
- Hospital Universitario Virgen De La Victoria | Oncologia
-
Seville, Spania, 41013
- Hospital Universitario Virgen Del Rocio S.L. | Oncologia
-
Valencia, Spania, 46009
- Fundacion Instituto Valenciano De Oncologia | Urologia
-
Valencia, Spania, 46015
- Hospital Arnau De Vilanova De Valencia | Oncologia
-
-
Alicante
-
Elche, Alicante, Spania, 3203
- Hospital General Universitario De Elche | Urologia
-
-
Balearic Islands
-
Manacor, Balearic Islands, Spania, 7500
- Hospital De Manacor | Urologia
-
Palma de Mallorca, Balearic Islands, Spania, 7120
- Hospital Universitari Son Espases | Oncologia
-
-
Barcelona
-
Sabadell, Barcelona, Spania, 08208
- Parc Tauli Hospital Universitari | Oncologia
-
-
Madrid
-
Alcorcón, Madrid, Spania, 28922
- Hospital Universitario Fundacion Alcorcon | Urologia
-
-
-
-
Berkshire
-
Reading, Berkshire, Storbritannia, RG1 5AN
- Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology
-
-
Essex
-
Colchester, Essex, Storbritannia, CO45JR
- East Suffolk and North Essex NHS Foundation Trust¦Colchester General Hospital - Oncology Trials Unit
-
-
Greater London
-
London, Greater London, Storbritannia, W6 8RF
- Charing Cross Hospital
-
London, Greater London, Storbritannia, NW1 2PG
- University College London Hospitals NHS Foundation Trust
-
-
Merseyside
-
Bebington, Merseyside, Storbritannia, CH63 4JY
- Clatterbridge Centre for Oncology
-
-
North East Lincolnshire
-
Scunthorpe, North East Lincolnshire, Storbritannia, DN15 7BH
- Scunthorpe General Hospital
-
-
Scotland
-
Glasgow, Scotland, Storbritannia, G12 0YN
- NHS Greater Glasgow & Clyde | Beatson West of Scotland Cancer Centre - Clinical Research Unit
-
-
Wales
-
Cardiff, Wales, Storbritannia, CF14 4XW
- Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
-
Llanelli, Wales, Storbritannia, SA14 8QF
- Prince Philip Hospital
-
-
West Midlands
-
Dudley, West Midlands, Storbritannia, DY1 2HQ
- Dudley Group NHS Foundation Trust ¦Russells Hall Hopsital - Oncology
-
-
West Yorkshire
-
Huddersfield, West Yorkshire, Storbritannia, HD3 3EA
- Calderdale and Huddersfield NHS Foundation Trust¦Huddersfield Royal Infirmary - Oncology
-
Wakefield, West Yorkshire, Storbritannia, WF1 4DG
- Mid Yorkshire Teaching NHS Trust¦Pinderfields Hospital - Oncology
-
-
-
-
Stockholm County
-
Stockholm, Stockholm County, Sverige, 171 76
- Karolinska Universitetssjukhuset
-
-
Uppsala County
-
Uppsala, Uppsala County, Sverige, 752 37
- Akademiska Sjukhuset
-
-
Västerbotten County
-
Umeå, Västerbotten County, Sverige, 901 85
- Norrlands Universitetssjukhus, Umea
-
-
Västra Götaland County
-
Gothenburg, Västra Götaland County, Sverige, 413 45
- Sahlgrenska Universitetssjukhuset
-
-
-
-
-
Daegu, Sør -Korea, 42601
- Keimyung University Dongsan Medical Center
-
Daegu, Sør -Korea, 700721
- Kyungpook National University Chilgok Hospital
-
Incheon, Sør -Korea, 21565
- Gachon University Gil Medical Center-Department of Urology
-
Seoul, Sør -Korea, 06351
- Samsung Medical Center - Oncology Department
-
Seoul, Sør -Korea, 137-701
- The Catholic University of Korea Seoul St. Mary's Hospital
-
-
Gwangju Gwang''yeogsi
-
Gwangju, Gwangju Gwang''yeogsi, Sør -Korea, 501-757
- Chonnam National University Hospital | Urology
-
-
North Chungcheong
-
Chungcheongbuk-do, North Chungcheong, Sør -Korea, 28644
- Chungbuk National University Hospital-Department of Urology
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, Sør -Korea, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Seoul Teugbyeolsi, Sør -Korea, 03080
- Seoul National University Hospital-Department of Urology
-
Seoul, Seoul Teugbyeolsi, Sør -Korea, 05505
- Asan Medical Center | Urology
-
Seoul, Seoul Teugbyeolsi, Sør -Korea, 06273
- Gangnam Severance Hospital, Yonsei University Health System-Department of Urology
-
-
-
-
Eastern Cape
-
Port Elizabeth, Eastern Cape, Sør-Afrika, 6045
- Langehoven Drive Oncology Centre
-
-
Gauteng
-
Pretoria, Gauteng, Sør-Afrika, 2
- University of Pretoria, Clinical Research Unit
-
-
Western Cape
-
Cape Town, Western Cape, Sør-Afrika, 7570
- Cape Gate Oncology Centre
-
Cape Town, Western Cape, Sør-Afrika, 7505
- Dept Radiation and Oncology Tygerberg Academic Hospital
-
George, Western Cape, Sør-Afrika, 6529
- Cancercare Outeniqua
-
Rondebosch, Western Cape, Sør-Afrika, 7700
- Cancercare Rondebosch Oncology
-
-
-
-
-
Kaohsiung City, Taiwan, 807377
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
-
Taichung, Taiwan, 404327
- China Medical University Hospital
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
Taoyuan District, Taiwan, 33305
- Chang Gung Memorial Hospital at Linkou
-
-
-
-
-
Brno, Tsjekkia, 65653
- Masarykuv onkologicky ustav
-
Jablonec nad Nisou, Tsjekkia, 46601
- Nemocnice Jablonec nad Nisou
-
Prague, Tsjekkia, 12808
- Vseobecna Fakultni nemocnice v Praze
-
Prague, Tsjekkia, 10034
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, Tsjekkia, 120 00
- Urocentrum Praha, s.r.o.
-
Prague, Tsjekkia, 160 00
- Androgeos, spol. s r.o.
-
-
-
-
-
Ankara, Tyrkia (Türkiye), 6560
- Gazi Universitesi Tip Fakultesi
-
-
-
-
Baden-Wurttemberg
-
Emmendingen, Baden-Wurttemberg, Tyskland, 79312
- Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger
-
Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Universitätsklinikum Freiburg
-
Mühlacker, Baden-Wurttemberg, Tyskland, 75417
- Urologische Gemeinschaftspraxis Muehlacker
-
Nürtingen, Baden-Wurttemberg, Tyskland, 72622
- Studienpraxis Urologie
-
Reutlingen, Baden-Wurttemberg, Tyskland, 72764
- Urologische Gemeinschaftspraxis Dr. Simone Maier
-
Tübingen, Baden-Wurttemberg, Tyskland, 72076
- Uniklinik Tübingen / Urologie
-
-
Bavaria
-
Erlangen, Bavaria, Tyskland, 91054
- Universitätsklinikum Erlangen
-
-
Lower Saxony
-
Braunschweig, Lower Saxony, Tyskland, 38126
- Städtisches Klinikum Braunschweig GmbH
-
-
North Rhine-Westphalia
-
Düsseldorf, North Rhine-Westphalia, Tyskland, 40225
- Universitätsklinikum Düsseldorf
-
Mülheim, North Rhine-Westphalia, Tyskland, 45468
- Praxis Drs. Tim Schneider /B. Schneider
-
Münster, North Rhine-Westphalia, Tyskland, 48149
- Universitatsklinikum Munster
-
Wuppertal, North Rhine-Westphalia, Tyskland, 42103
- Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Tyskland, 55101
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
-
-
Saxony-Anhalt
-
Magdeburg, Saxony-Anhalt, Tyskland, 39120
- Medizinische Fakultät der Otto-von-Guericke Universität
-
-
Thuringia
-
Jena, Thuringia, Tyskland, 7747
- Friedrich-Schiller-Uni. Jena
-
-
-
-
-
Cherkasy, Ukraina, 18009
- CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
-
Chernivtsi, Ukraina, 58001
- Regional communal non-profit enterprise 'Chernivtsi regional clinical hospital' - Urological department
-
Dnipro, Ukraina, 49102
- Municipal Non-commercial Enterprise 'City Clinical Hospital #4' of Dnipro City Council - City ?hemotherapy ?enter
-
Kharkiv, Ukraina, 61037
- Regional Medical Clinical Center of Urology and Nephrology n.a. V. I. Shapoval - Department of Oncologic Urology #5
-
Kyiv, Ukraina, 02660
- Kyiv City Hospital #3 - Department of Urology
-
Kyiv, Ukraina, 252053
- SE "Academician O.F. Vozianov Institute of Urology" of NAMSU - Division of Reconstructive Urology and Advanced Technologies
-
Uzhhorod, Ukraina, 88014
- Zakarpattia Anti-Tumor Centre - Chemotherapy Department
-
-
-
-
-
Szekszárd, Ungarn, 7100
- Tolna Varmegyei Balassa Janos Korhaz
-
Zalaegerszeg, Ungarn, 8900
- Zala Varmegyei Szent Rafael Korhaz
-
-
-
-
State of Vienna
-
Vienna, State of Vienna, Østerrike, 1090
- Universitätsklinikum AKH Wien
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- I stand til å gi signert informert samtykke som inkluderer overholdelse av kravene og begrensningene som er oppført i skjemaet for informert samtykke (ICF) og i denne protokollen.
- Deltakere som ble registrert i en hvilken som helst Bayer-sponset darolutamid-materstudie på tidspunktet for studieavslutning eller primær fullføring, som for tiden mottar darolutamid og opplever klinisk fordel av behandlingen.
- Deltakere som ikke har oppfylt noen behandlingsavbruddskriterier i materstudieprotokollen.
- Vilje til å fortsette å praktisere akseptable prevensjonsmetoder under studiet.
Ekskluderingskriterier:
- Deltakeren er ikke i stand til å oppfylle kravene til studien.
- Negativ nytte/risiko-forhold som bestemt av etterforskeren.
- Oppfylle eventuelle kriterier for behandlingsavbrudd av feederstudien deltakeren kommer fra.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Darolutamid (BAY1841788)
Deltakere som er registrert i den nåværende studien vil bruke dosen de ble tildelt i matestudien de kommer fra.
|
Deltakerne vil fortsette å motta darolutamidbehandling på dosenivået og administreringsskjemaet som tidligere ble tildelt i feeder-studien.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Forekomst av behandlingsfremkomne bivirkninger (TEAE)
Tidsramme: Inntil 4 år
|
Inntil 4 år
|
|
Forekomst av behandlingsfremkallende alvorlige bivirkninger (TESAE)
Tidsramme: Inntil 4 år
|
Inntil 4 år
|
|
Forekomst av medikamentrelaterte TEAE
Tidsramme: Inntil 4 år
|
Inntil 4 år
|
|
Forekomst av medikamentrelaterte TESAEs
Tidsramme: Inntil 4 år
|
Inntil 4 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antall doseendringer
Tidsramme: Inntil 4 år
|
Inntil 4 år
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20321
- 2019-003618-15 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Tilgjengeligheten av denne studiens data vil senere bli bestemt i henhold til Bayers forpliktelse til EFPIA/PhRMA "Prinsipler for ansvarlig deling av kliniske utprøvingsdata". Dette gjelder omfang, tidspunkt og prosess for datatilgang. Som sådan forplikter Bayer seg til å dele på forespørsel fra kvalifiserte forskere data fra kliniske utprøvinger på pasientnivå, data fra kliniske studier på studienivå og protokoller fra kliniske studier på pasienter for medisiner og indikasjoner godkjent i USA og EU som er nødvendig for å utføre legitim forskning. Dette gjelder data om nye medisiner og indikasjoner som er godkjent av EU og amerikanske reguleringsorganer 1. januar 2014 eller senere.
Interesserte forskere kan bruke www.vivli.org for å be om tilgang til anonymiserte data på pasientnivå og støttedokumenter fra kliniske studier for å utføre forskning. Informasjon om Bayer-kriteriene for listeføring av studier og annen relevant informasjon er gitt i medlemsdelen av portalen.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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