En studie av MK-5684 versus alternativt neste generasjons hormonmiddel (NHA) i metastatisk kastrasjonsresistent prostatakreft (mCRPC) Post One NHA (MK-5684-004)
19. oktober 2026 oppdatert av: Merck Sharp & Dohme LLC
En fase 3, randomisert, åpen studie av MK-5684 versus alternativ abirateronacetat eller enzalutamid hos deltakere med metastatisk kastrasjonsresistent prostatakreft (mCRPC) som utviklet seg på eller etter tidligere behandling med ett neste generasjons hormonmiddel (NHA)
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
Per Protocol Amendment 08, OS was moved to be a secondary outcome measure. Per Protocol Amendment 11, OS was returned to a primary outcome measure.
Studietype
Intervensjonell
Registrering (Antatt)
1314
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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Studiesteder
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New South Wales
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Macquarie University, New South Wales, Australia, 2109
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- Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)
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Westmead, New South Wales, Australia, 2145
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- Westmead Hospital ( Site 0212)
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Queensland
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Brisbane, Queensland, Australia, 4029
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- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)
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Victoria
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Clayton, Victoria, Australia, 3168
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- Monash Health ( Site 0219)
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Melbourne, Victoria, Australia, 3000
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- Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)
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São Paulo, Brasil, 01321-001
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- Hospital Paulistano ( Site 0259)
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Ceará
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Fortaleza, Ceará, Brasil, 60336-232
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Espírito Santo
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Vitória, Espírito Santo, Brasil, 29043-260
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- Hospital Santa Rita de Cassia ( Site 0271)
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 41680-430
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- Obras Sociais Irma Dulce ( Site 0255)
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Maranhão
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São Luís, Maranhão, Brasil, 65060-645
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30380-472
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- Hospital Mario Penna ( Site 0264)
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Uberaba, Minas Gerais, Brasil, 38025-350
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Paraná
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Curitiba, Paraná, Brasil, 80510-130
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- ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)
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Curitiba, Paraná, Brasil, 80730-150
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- Hospital Universitário Evangélico Mackenzie ( Site 0252)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
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- Hospital São Lucas da PUCRS ( Site 0270)
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Santa Catarina
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Itajaí, Santa Catarina, Brasil, 88301-220
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- Clínica de Neoplasias Litoral ( Site 0269)
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São Paulo
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Bragança Paulista, São Paulo, Brasil, 12916-542
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- Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)
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São José do Rio Preto, São Paulo, Brasil, 15090-000
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- Hospital de Base de São José do Rio Preto ( Site 0275)
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Taubaté, São Paulo, Brasil, 12030-200
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- Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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- Cross Cancer Institute ( Site 0281)
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British Columbia
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Abbotsford British Columbia, British Columbia, Canada, V2S 0C2
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- BC Cancer Abbotsford-Clinical Trials Unit ( Site 0287)
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Ontario
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Mississauga, Ontario, Canada, L5M 2N1
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- Trillium Health Partners - Credit Valley Hospital ( Site 0289)
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Ottawa, Ontario, Canada, K1H 8L6
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- The Ottawa Hospital - General Campus ( Site 0286)
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Toronto, Ontario, Canada, M4N 3M5
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- Sunnybrook Research Institute ( Site 0285)
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
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Québec, Quebec, Canada, G1J 1Z4
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Ta kontakt med:
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Araucania
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Temuco, Araucania, Chile, 4810218
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- CIDO SpA-Oncology ( Site 0302)
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Maule Region
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Talca, Maule Region, Chile, 3465584
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- Clinica Universidad Catolica del Maule-Oncology ( Site 0306)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8330024
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Santiago, Region M. de Santiago, Chile, 8420383
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Santiago, Region M. de Santiago, Chile, 7500921
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 111321
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- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)
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Ta kontakt med:
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Bogotá, Bogota D.C., Colombia, 110121
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- Los Cobos Medical Center ( Site 0336)
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Cesar Department
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Valledupar, Cesar Department, Colombia, 200001
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- Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia, 230002
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- IMAT S.A.S ( Site 0329)
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Santander Department
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Piedecuesta, Santander Department, Colombia, 681017
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- Fundación Cardiovascular de Colombia ( Site 0328)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
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Cali, Valle del Cauca Department, Colombia, 760042
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San José, Costa Rica, 10103
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Provincia de San José
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San José, Provincia de San José, Costa Rica, 10103
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Santa Ana, Provincia de San José, Costa Rica, 10903
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- Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)
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Harju
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Tallinn, Harju, Estland, 13419
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- North Estonia Medical Centre Foundation ( Site 1526)
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Tallinn, Harju, Estland, 11314
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Pärnumaa
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Pärnu, Pärnumaa, Estland, 80010
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Tartu
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Tartu, Tartu, Estland, 50406
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- Tartu University Hospital-Radiotherapy and oncology ( Site 1527)
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Arizona
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Tucson, Arizona, Forente stater, 85719
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California
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Irvine, California, Forente stater, 92612
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Los Angeles, California, Forente stater, 90404
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Orange, California, Forente stater, 92868
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Palo Alto, California, Forente stater, 94304
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Redlands, California, Forente stater, 92373
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Riverside, California, Forente stater, 92505
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- Kaiser Permanente Riverside Medical Center ( Site 0099)
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Sacramento, California, Forente stater, 95817
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San Francisco, California, Forente stater, 94121
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Vallejo, California, Forente stater, 94589
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- Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)
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Colorado
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Aurora, Colorado, Forente stater, 80045
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- University of Colorado Anschutz Medical Campus ( Site 0046)
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Highlands Ranch, Colorado, Forente stater, 80129
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- UCHealth Highlands Ranch Hospital ( Site 0111)
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Lakewood, Colorado, Forente stater, 80228
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Lone Tree, Colorado, Forente stater, 80124
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20010
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- Telefonnummer: 202-877-6583
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Florida
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Fort Myers, Florida, Forente stater, 33901
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Miami Beach, Florida, Forente stater, 33140
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- Mount Sinai Braman Comprehensive Cancer Center ( Site 0107)
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Pembroke Pines, Florida, Forente stater, 33028
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Georgia
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Atlanta, Georgia, Forente stater, 30342
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- Northside Hospital-Northside Hospital Oncology Network ( Site 0100)
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Illinois
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Elmhurst, Illinois, Forente stater, 60126
- Fullført
- Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
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Naperville, Illinois, Forente stater, 60540
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- Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
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Peoria, Illinois, Forente stater, 61615
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- Illinois Cancer Care ( Site 0104)
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- Telefonnummer: 309-240-6388
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Indiana
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Carmel, Indiana, Forente stater, 46032
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- Urology of Indiana - Carmel ( Site 0055)
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- Aktiv, ikke rekrutterende
- University of Kentucky Chandler Medical Center ( Site 0048)
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Maryland
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Baltimore, Maryland, Forente stater, 21201
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- Baltimore Veterans Affairs Medical Center ( Site 0069)
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Baltimore, Maryland, Forente stater, 21201
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Towson, Maryland, Forente stater, 21204
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Michigan
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Detroit, Michigan, Forente stater, 48202
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- Henry Ford Hospital ( Site 0015)
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- Telefonnummer: 313-916-1784
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Grand Rapids, Michigan, Forente stater, 49503
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- Cancer and Hematology Centers of Western Michigan ( Site 0005)
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- Telefonnummer: 616-399-6500
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Minnesota
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Marshall, Minnesota, Forente stater, 56258
- Rekruttering
- Avera Cancer Institute - Marshall ( Site 0122)
-
Ta kontakt med:
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- Telefonnummer: 605-601-1830
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Saint Louis Park, Minnesota, Forente stater, 55426
- Rekruttering
- HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
-
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- Study Coordinator
- Telefonnummer: 952-977-5555
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Saint Paul, Minnesota, Forente stater, 55101
- Rekruttering
- HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 651-254-1517
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Montana
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Billings, Montana, Forente stater, 59102
- Rekruttering
- St. Vincent Frontier Cancer Center-Research ( Site 0037)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 406-238-6685
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Nebraska
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Omaha, Nebraska, Forente stater, 68130
- Rekruttering
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 402-334-4773
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Nevada
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Las Vegas, Nevada, Forente stater, 89102
- Rekruttering
- OptumCare Cancer Care-Research Department ( Site 0078)
-
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- Study Coordinator
- Telefonnummer: 702-724-8787
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Las Vegas, Nevada, Forente stater, 89148
- Rekruttering
- Comprehensive Cancer Centers of Nevada ( Site 0010)
-
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- Study Coordinator
- Telefonnummer: 702-952-3449
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08903
- Rekruttering
- Rutgers Cancer Institute of New Jersey ( Site 0033)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 732-235-2465
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New York
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Syracuse, New York, Forente stater, 13210
- Rekruttering
- Associated Medical Professionals - Urology ( Site 0081)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 315-478-4185
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center ( Site 0043)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 216-844-3951
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Gahanna, Ohio, Forente stater, 43230
- Fullført
- Central Ohio Urology Group - Gahanna ( Site 0098)
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Zanesville, Ohio, Forente stater, 43701
- Fullført
- Genesis Healthcare System ( Site 0102)
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forente stater, 19004
- Rekruttering
- MidLantic urology ( Site 0022)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 610-667-3020
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Philadelphia, Pennsylvania, Forente stater, 19111
- Rekruttering
- Fox Chase Cancer Center ( Site 0076)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 267-512-1098
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South Carolina
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Charleston, South Carolina, Forente stater, 29401
- Rekruttering
- Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 843-792-7888
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South Dakota
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Aberdeen, South Dakota, Forente stater, 57401
- Rekruttering
- Avera Cancer Institute - Aberdeen ( Site 0123)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 605-601-1830
-
Mitchell, South Dakota, Forente stater, 57301
- Rekruttering
- Avera Cancer Institute - Mitchell ( Site 0121)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 605-601-1830
-
Pierre, South Dakota, Forente stater, 57501
- Rekruttering
- Avera Cancer Institute - Pierre ( Site 0118)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 605-224-3370
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Sioux Falls, South Dakota, Forente stater, 57105
- Rekruttering
- Avera Cancer Institute- Research ( Site 0094)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 605-322-6900
-
Yankton, South Dakota, Forente stater, 57078
- Rekruttering
- Avera Cancer Institute - Yankton ( Site 0117)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 605-655-1800
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Tennessee
-
Germantown, Tennessee, Forente stater, 38138
- Rekruttering
- The West Clinic, PLLC dba West Cancer Center ( Site 0063)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 901-683-0055
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Texas
-
Austin, Texas, Forente stater, 78731
- Rekruttering
- Texas Oncology - Central/South Texas ( Site 8003)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 512-427-9400
-
Dallas, Texas, Forente stater, 75246
- Rekruttering
- Texas Oncology - DFW ( Site 8001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 214-370-1000
-
Dallas, Texas, Forente stater, 75243
- Fullført
- Cancer Clinics of North Texas ( Site 0077)
-
Houston, Texas, Forente stater, 77024
- Rekruttering
- Texas Oncology - Gulf Coast ( Site 8002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 713-467-1722
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908
- Rekruttering
- University of Virginia Health System ( Site 0054)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 434-327-3029
-
Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Inova Schar Cancer Institute ( Site 0017)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 571-472-1180
-
Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Virginia Cancer Specialists (VCS) ( Site 8004)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 844-482-4812
-
Richmond, Virginia, Forente stater, 23219
- Rekruttering
- VCU Health Adult Outpatient Pavillion ( Site 0061)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 804-628-6430
-
Roanoke, Virginia, Forente stater, 24014
- Rekruttering
- Blue Ridge Cancer Care ( Site 0004)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 540-982-0237
-
-
Washington
-
Spokane, Washington, Forente stater, 99202
- Rekruttering
- Spokane Urology ( Site 0035)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 509-747-3147
-
Vancouver, Washington, Forente stater, 98684
- Aktiv, ikke rekrutterende
- Northwest Cancer Specialists (Compass Oncology) ( Site 8008)
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Medical College of Wisconsin ( Site 0020)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 414-805-6700
-
-
-
-
-
Paris, Frankrike, 75014
- Rekruttering
- Groupe Hospitalier Paris Saint Joseph ( Site 0465)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33144128524
-
-
Aquitaine
-
Bordeaux, Aquitaine, Frankrike, 33076
- Rekruttering
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33556333333
-
-
Auvergne-Rhône-Alpes
-
Lyon Cedex08, Auvergne-Rhône-Alpes, Frankrike, 69373
- Rekruttering
- CENTRE LEON BERARD ( Site 0459)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 33469856243
-
-
Bas-Rhin
-
Strasbourg, Bas-Rhin, Frankrike, 67200
- Rekruttering
- Hopitaux Universitaires de Strasbourg- Hopital de Hautepierre ( Site 0451)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33368767208
-
-
Finistere
-
Brest, Finistere, Frankrike, 29200
- Rekruttering
- CHU-BREST Cavale Blanche ( Site 0456)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33298223395
-
-
Haute-Garonne
-
Quint-Fonsegrives, Haute-Garonne, Frankrike, 31130
- Fullført
- Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)
-
-
Hauts-de-France
-
Lille, Hauts-de-France, Frankrike, 59000
- Rekruttering
- Centre Bourgogne ( Site 0464)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33 3 20 00 97 57
-
-
Hauts-de-Seine
-
Suresnes, Hauts-de-Seine, Frankrike, 92150
- Rekruttering
- Hôpital Foch ( Site 0455)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33146253581
-
-
Puy-de-Dome
-
Clermont-Ferrand, Puy-de-Dome, Frankrike, 63003
- Rekruttering
- Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33473278005
-
-
Val-de-Marne
-
Villejuif, Val-de-Marne, Frankrike, 94800
- Rekruttering
- Gustave Roussy ( Site 0452)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33 1 42 11 42 11
-
-
Vaucluse
-
Avignon, Vaucluse, Frankrike, 84000
- Fullført
- Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)
-
-
-
-
-
Guatemala City, Guatemala, 01009
- Rekruttering
- MEDI-K ( Site 0576)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 50249340261
-
Guatemala City, Guatemala, 01010
- Rekruttering
- CELAN,S.A ( Site 0579)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 50242142081
-
Guatemala City, Guatemala, 01010
- Rekruttering
- INTEGRA Cancer Institute-Oncology ( Site 0578)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 50254530410
-
Guatemala City, Guatemala, 01010
- Rekruttering
- Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 50230635474
-
Guatemala City, Guatemala, 01015
- Rekruttering
- Sanatorio Nuestra Senora del Pilar ( Site 0580)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 50258190718
-
-
-
-
Achaia
-
Pátrai, Achaia, Hellas, 26504
- Fullført
- UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)
-
-
Attica
-
Athens, Attica, Hellas, 115 28
- Rekruttering
- Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302132162513
-
Chaïdári, Attica, Hellas, 124 62
- Rekruttering
- ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302105832547
-
-
-
-
-
Central, Hong Kong, 999077
- Rekruttering
- Hong Kong Integrated Oncology Centre ( Site 0603)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +85237006888
-
Hong Kong, Hong Kong
- Rekruttering
- Queen Mary Hospital ( Site 0602)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +85222553838
-
-
-
-
-
Dublin, Irland, D24 NR0A
- Rekruttering
- Tallaght University Hospital ( Site 0651)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +35314144299
-
-
Dublin
-
Dublin, Dublin, Irland, D04 T6F4
- Rekruttering
- St. Vincent's University Hospital ( Site 0652)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +35312214000
-
-
-
-
-
Afula, Israel, 1834111
- Rekruttering
- Emek Medical Center ( Site 0680)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0546708579
-
Haifa, Israel, 3109601
- Rekruttering
- Rambam Health Care Campus-Oncology Division ( Site 0676)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 04-7776234
-
Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah Medical Center ( Site 0683)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02-6777111
-
Jerusalem, Israel, 9103102
- Rekruttering
- Shaare Zedek Medical Center ( Site 0679)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02-666-6044
-
Kfar Saba, Israel, 4428164
- Rekruttering
- Meir Medical Center. ( Site 0682)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0503745684
-
Petah Tikva, Israel, 4941492
- Rekruttering
- Rabin Medical Center ( Site 0678)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 039378074
-
Ramat Gan, Israel, 5265601
- Rekruttering
- Sheba Medical Center ( Site 0677)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-35302191
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Sourasky Medical Center ( Site 0681)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-36972951
-
-
-
-
-
Catania, Italia, 95126
- Rekruttering
- Ospedale Cannizzaro ( Site 1455)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +393487142015
-
Foggia, Italia, 71100
- Rekruttering
- Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390881736426
-
Milan, Italia, 20132
- Rekruttering
- Ospedale San Raffaele-Oncologia Medica ( Site 1451)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390226435668
-
Terni, Italia, 05100
- Rekruttering
- Azienda Ospedaliera Santa Maria Terni ( Site 1458)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390744205410
-
-
Emilia-Romagna
-
Meldola, Emilia-Romagna, Italia, 47014
- Rekruttering
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390543739100
-
-
Lombardy
-
Milan, Lombardy, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00390223903033
-
-
-
-
-
Akita, Japan, 010-8543
- Rekruttering
- Akita University Hospital ( Site 0728)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81188341111
-
Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital ( Site 0745)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81926411151
-
Fukushima, Japan, 960-1295
- Rekruttering
- Fukushima Medical University Hospital ( Site 0758)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81245471111
-
Gifu, Japan, 501-1112
- Rekruttering
- Gifu University Hospital ( Site 0736)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-58-230-6000
-
Hiroshima, Japan, 734-8551
- Fullført
- Hiroshima University Hospital ( Site 0743)
-
Kagoshima, Japan, 890-8520
- Fullført
- Kagoshima University Hospital ( Site 0754)
-
Kumamoto, Japan, 860-0008
- Rekruttering
- National Hospital Organization Kumamoto Medical Center ( Site 0749)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81963536501
-
Miyazaki, Japan, 880-8510
- Rekruttering
- Miyazaki Prefectural Miyazaki Hospital ( Site 0752)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81985244181
-
Miyazaki, Japan, 889-1692
- Rekruttering
- University of Miyazaki Hospital ( Site 0751)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-98-585-1510
-
Nagano, Japan, 381-8551
- Rekruttering
- Nagano Municipal Hospital ( Site 0757)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81262951199
-
Ōita, Japan, 870-0263
- Fullført
- National Hospital Organization Oita Medical Center ( Site 0750)
-
-
Chiba
-
Sakura, Chiba, Japan, 285-8741
- Rekruttering
- Toho University Sakura Medical Center ( Site 0730)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81434628811
-
-
Fukui
-
Eiheiji-cho,Yoshida-gun, Fukui, Japan, 910-1193
- Rekruttering
- University of Fukui Hospital ( Site 0735)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81776613111
-
-
Fukuoka
-
Kitakyushu, Fukuoka, Japan, 807-8556
- Rekruttering
- Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81936031611
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8543
- Rekruttering
- Sapporo Medical University Hospital ( Site 0726)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-11-611-2111
-
Sapporo, Hokkaido, Japan, 060-8648
- Rekruttering
- Hokkaido University Hospital ( Site 0756)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81117161161
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 650-0017
- Rekruttering
- Kobe University Hospital ( Site 0741)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81783825111
-
-
Ishikawa-ken
-
Mukai-awagasaki, Ishikawa-ken, Japan, 920-0265
- Rekruttering
- Kanazawa Medical University Hospital ( Site 0734)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-76-286-3511
-
-
Kagawa-ken
-
Kita, Kagawa-ken, Japan, 761-0701
- Rekruttering
- Kagawa University Hospital ( Site 0744)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81878985111
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 232-0024
- Rekruttering
- Yokohama City University Medical Center ( Site 0733)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81452615656
-
-
Mie-ken
-
Tsu, Mie-ken, Japan, 514-8507
- Rekruttering
- Mie University Hospital ( Site 0737)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-59-232-1111
-
-
Nagasaki
-
Ōmura, Nagasaki, Japan, 856-8562
- Rekruttering
- National Hospital Organization Nagasaki Medical Center ( Site 0748)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-957-52-3121
-
-
Nara
-
Kashihara, Nara, Japan, 634-8522
- Rekruttering
- Nara Medical University Hospital ( Site 0742)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81744223051
-
-
Okinawa
-
Shimajiri, Okinawa, Japan, 901-0417
- Rekruttering
- Nanbu Tokushukai Hospital ( Site 0755)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-98-998-3221
-
-
Osaka
-
Hirakata, Osaka, Japan, 573-1191
- Rekruttering
- Kansai Medical University Hospital ( Site 0739)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-72-804-0101
-
Sakai, Osaka, Japan, 599-8247
- Rekruttering
- Bell Land General Hospital ( Site 0740)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81722342001
-
Suita, Osaka, Japan, 565-0871
- Rekruttering
- The University of Osaka Hospital ( Site 0738)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-6-6879-5111
-
-
Saga-ken
-
Saga, Saga-ken, Japan, 840-8571
- Rekruttering
- Saga-Ken Medical Centre Koseikan ( Site 0747)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81952242171
-
-
Tokyo
-
Minato, Tokyo, Japan, 105-8471
- Rekruttering
- The Jikei University Hospital ( Site 0731)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81339728111
-
tabashi City, Tokyo, Japan, 173-8610
- Fullført
- Nihon University Itabashi Hospital ( Site 0732)
-
-
-
-
Anhui
-
Hefei, Anhui, Kina, 230000
- Rekruttering
- The Second Hospital Of Anhui Medical University ( Site 1633)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +86 02782201756
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100034
- Rekruttering
- Peking University First Hospital-Urology ( Site 1602)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 13910688432
-
Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer hospital-Urinary Surgery ( Site 1620)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 86 010 8812 1122
-
Beijing, Beijing Municipality, Kina, 130021
- Rekruttering
- Beijing Cancer Hospital ( Site 1623)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +861088196393
-
Beijing, Beijing Municipality, Kina, 100853
- Rekruttering
- First Medical Center of Chinese PLA General Hospital ( Site 1601)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 13693556315
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400030
- Rekruttering
- Chongqing University Cancer Hospital ( Site 1603)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02365075629
-
Chongqing, Chongqing Municipality, Kina, 400038
- Rekruttering
- Southwest Hospital of Third Military Medical University ( Site 1645)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 023 68765878
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350005
- Rekruttering
- The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +86 591-87981262
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510700
- Rekruttering
- Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +86 20-87341851
-
Guangzhou, Guangdong, Kina, 510000
- Rekruttering
- The first affiliated hospital of Guangzhou medical university ( Site 1637)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +86 2083062114
-
-
Hubei
-
Wuhan, Hubei, Kina, 430079
- Rekruttering
- Hubei Cancer Hospital-Urinary surgery ( Site 1631)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 8613907110640
-
Wuhan, Hubei, Kina, 430000
- Rekruttering
- Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 027-83665555
-
Wuhan, Hubei, Kina, 430014
- Rekruttering
- The Central Hospital of Wuhan ( Site 1635)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +86 02782211667
-
-
Hunan
-
Changsha, Hunan, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital ( Site 1630)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +86073189762271
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210008
- Rekruttering
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 86-025-83106666
-
Nantong, Jiangsu, Kina, 226361
- Rekruttering
- Nantong Tumor Hospital-Urology ( Site 1609)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0513-86729024
-
Wuxi, Jiangsu, Kina, 214023
- Rekruttering
- Wuxi People's Hospital ( Site 1612)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0510-85350351
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710061
- Rekruttering
- The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 029-85323112
-
Xi'an, Shaanxi, Kina, 710004
- Rekruttering
- The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 029-87679000
-
-
Shandong
-
Yantai, Shandong, Kina, 264099
- Rekruttering
- Yantai Yuhuangding Hospital ( Site 1622)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 86 0535 6691999
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200041
- Rekruttering
- Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 021-62483180-571301
-
Shanghai, Shanghai Municipality, Kina, 200001
- Rekruttering
- Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: (021)58709251
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University-Urology Surgery ( Site 1642)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +86028-85422114
-
Nanchong, Sichuan, Kina, 500643
- Rekruttering
- Nanchong Central Hospital-urology ( Site 1647)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0817-2606822
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300211
- Rekruttering
- The Second Hospital of Tianjin Medical University ( Site 1616)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +862288326748
-
-
Xinjiang
-
Ürümqi, Xinjiang, Kina, 830000
- Rekruttering
- Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 86 09917819156
-
-
Yunnan
-
Kunming, Yunnan, Kina, 650107
- Rekruttering
- Yunnan Province Cancer Hospital ( Site 1643)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0871-68179210
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310014
- Rekruttering
- Zhejiang Provincial People's Hospital-Urology ( Site 1641)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0571-85893646
-
Jiaxing, Zhejiang, Kina, 314001
- Rekruttering
- The First Hospital of Jiaxing-urology ( Site 1605)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 86-0573-82519999
-
Ningbo, Zhejiang, Kina, 315010
- Rekruttering
- Ningbo First Hospital-Urology ( Site 1608)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8616301635665
-
Wenzhou, Zhejiang, Kina, 325015
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8613601635665
-
-
-
-
-
Liepāja, Latvia, LV3414
- Aktiv, ikke rekrutterende
- Liepaja Regional Hospital ( Site 1553)
-
Riga, Latvia, 1002
- Rekruttering
- Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +371 29262596
-
-
-
-
-
Vilnius, Litauen, LT-08406
- Rekruttering
- Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 1577)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +37052786815
-
-
Kaunas County
-
Kaunas, Kaunas County, Litauen, 50161
- Rekruttering
- Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +37037326090
-
-
-
-
-
Kuala Lumpur, Malaysia, 50586
- Rekruttering
- Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +60326155810
-
-
Johor
-
Johor Bahru, Johor, Malaysia, 81100
- Rekruttering
- Hospital Sultan Ismail ( Site 0905)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6073565155
-
-
Kuala Lumpur
-
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
- Rekruttering
- University Malaya Medical Centre ( Site 0902)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +60479492351
-
-
Putrajaya
-
Putrajaya, Putrajaya, Malaysia, 62250
- Fullført
- National Cancer Institute ( Site 0904)
-
-
Sarawak
-
Kuching, Sarawak, Malaysia, 93586
- Rekruttering
- Sarawak General Hospital-Radiotherapy Unit ( Site 0901)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6082276820
-
-
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44630
- Rekruttering
- CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 3331721132
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 03100
- Rekruttering
- Health Pharma Professional Research S.A. de C.V: ( Site 0929)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 5591974888
-
Mexico City, Mexico City, Mexico, 11810
- Rekruttering
- Higiea Oncologia ( Site 0938)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +525554137773
-
Mexico City, Mexico City, Mexico, 68020
- Rekruttering
- Centro de Investigacion Clinica de Oaxaca ( Site 0934)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +529515473137
-
Tlalpan, Mexico City, Mexico, 14308
- Rekruttering
- Quemex Medical and Research ( Site 0937)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +525556783461
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Rekruttering
- Filios Alta Medicina ( Site 0931)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +528183478742
-
Monterrey, Nuevo León, Mexico, 64460
- Rekruttering
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +528110665640
-
Monterrey, Nuevo León, Mexico, 64718
- Rekruttering
- Eukarya Pharmasite S.C. ( Site 0939)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +5218115009790
-
-
-
-
-
Auckland, New Zealand, 1023
- Rekruttering
- Auckland City Hospital ( Site 1033)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6493074949 x 21468
-
-
Otago
-
Dunedin, Otago, New Zealand, 9016
- Fullført
- Dunedin Hospital ( Site 1032)
-
-
-
-
-
Lima, Peru, 15036
- Rekruttering
- IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +51941042554
-
Lima, Peru, 15036
- Rekruttering
- Oncosalud-Clinical Research ( Site 1057)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01 2053500
-
Lima, Peru, 15036
- Rekruttering
- Aliada-Oncologìa ( Site 1055)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 5116505000
-
Lima, Peru, 15038
- Aktiv, ikke rekrutterende
- INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)
-
-
-
-
-
Braga, Portugal, 4710-243
- Rekruttering
- Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 351253027249
-
Lisbon, Portugal, 1350-352
- Rekruttering
- Hospital CUF - Tejo ( Site 1157)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +35121 392 6100
-
Lisbon, Portugal, 1649-035
- Rekruttering
- Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00351217805000
-
Porto, Portugal, 4099-001
- Rekruttering
- Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 351222077500
-
-
Lisbon District
-
Alcabideche, Lisbon District, Portugal, 2755-009
- Rekruttering
- Hospital de Cascais Doutor José de Almeida ( Site 1158)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: (351) 214653000
-
-
Porto District
-
Vila Nova de Gaia, Porto District, Portugal, 4434-502
- Rekruttering
- Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 351227865100
-
-
-
-
-
Ponce, Puerto Rico, 00717
- Rekruttering
- Ad-Vance Medical Research-Research ( Site 1177)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +1787-651-6697
-
Ponce, Puerto Rico, 00716
- Fullført
- Advance Urology and Laparoscopic Center ( Site 1178)
-
San Juan, Puerto Rico, 00909
- Rekruttering
- Pan American Center for Oncology Trials - Ciudadela ( Site 1176)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +1 787-407-3333
-
-
-
-
-
Bucharest, Romania, 014142
- Rekruttering
- Delta Health Care SRL ( Site 1507)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +40 21 9977
-
Bucharest, Romania, 050659
- Rekruttering
- Spitalul Clinic ''Prof Dr. Theodor Burghele'' ( Site 1505)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +40214106910
-
Bucharest, Romania, 11461
- Rekruttering
- Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 1504)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +40213161600
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400015
- Fullført
- Cardiomed SRL Cluj-Napoca ( Site 1503)
-
Florești, Cluj, Romania, 407280
- Fullført
- SC Radiotherapy Center Cluj SRL ( Site 1502)
-
-
Dolj
-
Craiova, Dolj, Romania, 200746
- Rekruttering
- Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +40731604432
-
-
-
-
Central Singapore
-
Singapore, Central Singapore, Singapore, 168583
- Rekruttering
- National Cancer Centre Singapore ( Site 1202)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6564368000
-
Singapore, Central Singapore, Singapore, 308433
- Rekruttering
- Tan Tock Seng Hospital-Medical Oncology ( Site 1203)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +65-62566011
-
Singapore, Central Singapore, Singapore, 169608
- Rekruttering
- Singapore General Hospital ( Site 1204)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6590059585
-
Singapore, Central Singapore, Singapore, 119074
- Rekruttering
- National University Hospital ( Site 1201)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 6569082222
-
-
-
-
Nitra Region
-
Nitra, Nitra Region, Slovakia, 949 01
- Rekruttering
- UROEXAM ( Site 1479)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +421377729428
-
-
Trenčín Region
-
Trenčín, Trenčín Region, Slovakia, 911 01
- Rekruttering
- Privatna Urologicka Ambulancia ( Site 1478)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +421905343753
-
-
-
-
-
Burgos, Spania, 09006
- Rekruttering
- Hospital Universitario de Burgos-Oncología ( Site 1281)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34947281800 (35729)
-
Málaga, Spania, 29004
- Rekruttering
- Hospital Quirón Málaga ( Site 1286)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 95 194 00 00
-
-
Barcelona
-
Sabadell, Barcelona, Spania, 08208
- Rekruttering
- Hospital Universitari Parc Tauli-oncologia ( Site 1282)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34932240084
-
-
Catalonia
-
Barcelona, Catalonia, Spania, 08036
- Rekruttering
- HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34932275402
-
-
Gerona
-
Girona, Gerona, Spania, 17007
- Rekruttering
- Institut Català d'Oncologia (ICO) - Girona ( Site 1285)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34972225834
-
-
La Coruna
-
A Coruña, La Coruna, Spania, 15006
- Rekruttering
- Complexo Hospitalario Universitario A Coruna ( Site 1288)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 981178000 Ext 291471
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spania, 35016
- Rekruttering
- Hospital Insular de Gran Canaria-Oncology ( Site 1280)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34928441738
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spania, 28223
- Rekruttering
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34914521987
-
-
-
-
-
Manchester, Storbritannia, m20 4bx
- Rekruttering
- The Christie NHS Foundation Trust ( Site 1436)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441614463000
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Storbritannia, CB2 2QQ
- Rekruttering
- Addenbrooke's Hospital ( Site 1426)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01223216083
-
-
Derbyshire
-
Derby, Derbyshire, Storbritannia, DE22 3NE
- Rekruttering
- Royal Derby Hospital ( Site 1431)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441332340131
-
-
Devon
-
Torquay, Devon, Storbritannia, TQ2 7AA
- Rekruttering
- Torbay Hospital ( Site 1429)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01803 656627
-
-
England
-
Northwood, England, Storbritannia, HA6 2RN
- Rekruttering
- Mount Vernon Cancer Centre ( Site 1440)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0203 826 2164
-
Truro, England, Storbritannia, TR1 3LJ
- Rekruttering
- The Royal Cornwall Hospital ( Site 1430)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01872258345
-
-
Glasgow City
-
Glasgow, Glasgow City, Storbritannia, G12 0YN
- Rekruttering
- The Beatson West of Scotland Cancer Centre ( Site 1428)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441413017000
-
-
London, City of
-
London, London, City of, Storbritannia, SW17 0QT
- Fullført
- St. George's Hospital-Oncology ( Site 1441)
-
London, London, City of, Storbritannia, NW1 2PG
- Rekruttering
- University College London Hospital ( Site 1437)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0203 447 3042
-
London, London, City of, Storbritannia, SE1 9RT
- Rekruttering
- Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02071882007
-
London, London, City of, Storbritannia, W6 8RF
- Rekruttering
- Charing Cross Hospital ( Site 1434)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4402033138335
-
-
Oxfordshire
-
Oxford, Oxfordshire, Storbritannia, OX4 6LB
- Rekruttering
- GenesisCare - Oxford ( Site 1442)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +447407796352
-
-
Windsor And Maidenhead
-
Windsor, Windsor And Maidenhead, Storbritannia, SL4 3HD
- Rekruttering
- GenesisCare - Windsor ( Site 1443)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +447879262807
-
-
-
-
Stockholm County
-
Stockholm, Stockholm County, Sverige, 171 64
- Rekruttering
- Karolinska Universitetssjukhuset Solna ( Site 1302)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46812370000
-
-
Uppsala County
-
Uppsala, Uppsala County, Sverige, 751 85
- Rekruttering
- Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0046186110000
-
-
-
-
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital-Urology ( Site 1251)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82-053-3027
-
Seoul, Sør -Korea, 06591
- Rekruttering
- The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82222581401
-
-
Kyonggi-do
-
Goyang-si, Kyonggi-do, Sør -Korea, 10408
- Rekruttering
- National Cancer Center-Center for Urologic Cancer ( Site 1254)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 82-31-920-1740
-
Seongnam, Kyonggi-do, Sør -Korea, 13620
- Rekruttering
- Seoul National University Bundang Hospital-Urology ( Site 1253)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 82-31-787-7342
-
-
Kyongsangbuk-do
-
Buk-gu, Kyongsangbuk-do, Sør -Korea, 41404
- Rekruttering
- Kyungpook National University Chilgok Hospital-Urology ( Site 1252)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82532002400
-
-
Kyongsangnam-do
-
Pusan, Kyongsangnam-do, Sør -Korea, 50612
- Rekruttering
- Pusan National University Yangsan Hospital ( Site 1256)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82553602672
-
-
-
-
Eastern Cape
-
Port Elizabeth, Eastern Cape, Sør-Afrika, 6055
- Rekruttering
- CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 27413630581
-
-
Gauteng
-
Johannesburg, Gauteng, Sør-Afrika, 2193
- Rekruttering
- Wits Clinical Research ( Site 1234)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +113390600
-
Pretoria, Gauteng, Sør-Afrika, 0040
- Rekruttering
- Wilgers Oncology Centre ( Site 1232)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +27128072744
-
Pretoria, Gauteng, Sør-Afrika, 0181
- Rekruttering
- LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +27123466701
-
Pretoria, Gauteng, Sør-Afrika, 0084
- Rekruttering
- Curo Oncology. ( Site 1237)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +27 12 335 6771
-
-
Western Cape
-
Cape Town, Western Cape, Sør-Afrika, 7570
- Fullført
- Cape Town Oncology Trials ( Site 1233)
-
-
-
-
-
Kaohsiung City, Taiwan, 83301
- Rekruttering
- Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886-7-7317123 #3267
-
Kaohsiung City, Taiwan, 81362
- Rekruttering
- Kaohsiung Veterans General Hospital ( Site 1337)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88673422121x73016
-
Taichung, Taiwan, 40447
- Rekruttering
- China Medical University Hospital-Department of Urology ( Site 1335)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886-4-2205-2121
-
Taichung, Taiwan, 40705
- Rekruttering
- Taichung Veterans General Hospital ( Site 1338)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886-4-23592525
-
Taipei, Taiwan, 112
- Rekruttering
- Taipei Veterans General Hospital ( Site 1332)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886228757519x315
-
Taoyuan, Taiwan, 333
- Rekruttering
- Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886-4-23592525
-
-
Tainan
-
Tainan, Tainan, Taiwan, 71004
- Rekruttering
- Chi Mei Medical Center ( Site 1336)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 886 933072414
-
-
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Rekruttering
- Faculty of Medicine Siriraj Hospital ( Site 1356)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6686-089-9245
-
Pathumwan, Bangkok, Thailand, 10330
- Rekruttering
- Chulalongkorn University ( Site 1355)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6622564533
-
-
Changwat Khon Kaen
-
Muang, Changwat Khon Kaen, Thailand, 40002
- Rekruttering
- Faculty of Medicine - Khon Kaen University ( Site 1351)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +669-7141913
-
-
Changwat Songkhla
-
Hat Yai, Changwat Songkhla, Thailand, 90110
- Rekruttering
- Songklanagarind hospital ( Site 1352)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: .+6674451250
-
-
Chiang Mai
-
Muang, Chiang Mai, Thailand, 50200
- Rekruttering
- Maharaj Nakorn Chiang Mai Hospital ( Site 1353)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6653936046
-
-
-
-
-
Olomouc, Tsjekkia, 77900
- Rekruttering
- Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420588444295
-
Prague, Tsjekkia, 12808
- Rekruttering
- Vseobecna fakultni nemocnice v Praze ( Site 0406)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420224962219
-
-
Brno-mesto
-
Brno, Brno-mesto, Tsjekkia, 656 53
- Rekruttering
- Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420543136216
-
-
Liberec Region
-
Liberec, Liberec Region, Tsjekkia, 460 01
- Fullført
- Krajská nemocnice Liberec-Department of Urology ( Site 0407)
-
-
Praha 5
-
Prague, Praha 5, Tsjekkia, 150 06
- Rekruttering
- Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420224434700
-
-
South Moravian
-
Brno, South Moravian, Tsjekkia, 602 00
- Rekruttering
- Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420543183087
-
-
-
-
-
Adana, Tyrkia (Türkiye), 01250
- Rekruttering
- Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 03223272727
-
Ankara, Tyrkia (Türkiye), 06230
- Rekruttering
- Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 03123053217
-
Ankara, Tyrkia (Türkiye), 06800
- Rekruttering
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +903125526000
-
Istanbul, Tyrkia (Türkiye), 34010
- Rekruttering
- Koc Universitesi Hastanesi ( Site 1384)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +908502508250
-
Istanbul, Tyrkia (Türkiye), 34147
- Rekruttering
- T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +902124147171
-
Istanbul, Tyrkia (Türkiye), 34668
- Rekruttering
- Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +902124143000
-
Istanbul, Tyrkia (Türkiye), 34722
- Rekruttering
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02166065200
-
Izmir, Tyrkia (Türkiye), 35100
- Rekruttering
- Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +902323903917
-
Samsun, Tyrkia (Türkiye), 55200
- Rekruttering
- Samsun Medical Park Hastanesi-medical oncology ( Site 1382)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +90 (539) 780 90 07
-
-
-
-
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Berlin, Tyskland, 10967
- Rekruttering
- Vivantes Klinikum Am Urban ( Site 0512)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 004930130226301
-
Berlin, Tyskland, 10117
- Rekruttering
- Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0049 30 450615285
-
-
Baden-Wurttemberg
-
Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Rekruttering
- Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4976127028900
-
Heidelberg, Baden-Wurttemberg, Tyskland, 69120
- Rekruttering
- Universitaetsklinikum Heidelberg ( Site 0531)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +496221565982
-
Nürtingen, Baden-Wurttemberg, Tyskland, 72622
- Rekruttering
- Studienpraxis Urologie ( Site 0529)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 491703809223
-
-
Bavaria
-
Munich, Bavaria, Tyskland, 81675
- Aktiv, ikke rekrutterende
- klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)
-
Regensburg, Bavaria, Tyskland, 93053
- Rekruttering
- Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +499417827524
-
-
Hesse
-
Marburg, Hesse, Tyskland, 35043
- Fullført
- Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)
-
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Lower Saxony
-
Göttingen, Lower Saxony, Tyskland, 37075
- Rekruttering
- Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4955139 68145
-
-
North Rhine-Westphalia
-
Bergisch Gladbach, North Rhine-Westphalia, Tyskland, 51465
- Rekruttering
- Marien-Krankenhaus ( Site 0515)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4922029384311
-
Cologne, North Rhine-Westphalia, Tyskland, 50937
- Fullført
- Universitaetsklinikum Koeln ( Site 0518)
-
Duisburg, North Rhine-Westphalia, Tyskland, 47169
- Rekruttering
- Urologicum Duisburg ( Site 0538)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4920360012919
-
-
Saxony
-
Dresden, Saxony, Tyskland, 01307
- Fullført
- Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)
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-
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-
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Debrecen, Ungarn, 4032
- Aktiv, ikke rekrutterende
- Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)
-
-
Borsod-Abauj Zemplen county
-
Miskolc, Borsod-Abauj Zemplen county, Ungarn, 3526
- Rekruttering
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +36204108060
-
-
Nógrád megye
-
Salgótarján, Nógrád megye, Ungarn, 3100
- Rekruttering
- Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3632522000
-
-
Pest County
-
Budapest, Pest County, Ungarn, 1122
- Rekruttering
- Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +36122486001171
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)
- Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer [mHSPC] or non-metastatic hormone-sensitive prostate cancer [nmHSPC]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer [mCRPC] or non-metastatic castration-resistant prostate cancer [nmCRPC]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
- Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- Has ongoing androgen deprivation therapy (ADT) with serum testosterone <50 ng/dL (<1.7 nM)
- Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
- Has adequate organ function
- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has presence of gastrointestinal condition
- Is unable to swallow capsules/tablets
- Has history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
- Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) <110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
- Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
- History or family history of long QTc syndrome
- Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
- Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
- Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
- Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
- Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
- Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
- Active infection requiring systemic therapy
- Has concurrent active Hepatitis B virus and Hepatitis C virus infection
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Daily Corticosteroids + Opevesostat
Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular [IM]) will also be provided to participants for use as rescue medication. |
Administered orally
Andre navn:
Administered orally Administered orally Administered orally or IM as a rescue drug |
|
Aktiv komparator: Alternative Next-Generation Hormonal Agent (NHA)
Participants receive abiraterone 1000mg QD by oral tablets plus prednisone 5 mg BID by oral tablets or enzalutamide 160 mg QD by oral tablets until disease progression. |
Administered orally
Andre navn:
Administered orally
Andre navn:
Administered orally |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 82 months
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 82 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiographic Progression-Free Survival (rPFS)
Tidsramme: Up to approximately 52 months
|
rPFS is defined as the time from randomization to the first documented disease progression per PCWG-modified RECIST 1.1 by BICR or death due to any cause, whichever occurs first. |
Up to approximately 52 months
|
|
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Tidsramme: Up to approximately 82 months
|
TFST is defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurred first. |
Up to approximately 82 months
|
|
Objective Response Rate (ORR)
Tidsramme: Up to approximately 82 months
|
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG-modified RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. |
Up to approximately 82 months
|
|
Duration of Response (DOR)
Tidsramme: Up to approximately 82 months
|
For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death from any cause, whichever occurs first. |
Up to approximately 82 months
|
|
Time to Pain Progression (TTPP)
Tidsramme: Up to approximately 82 months
|
TTPP is defined as the time from randomization to pain progression. TTTP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm [AQA] Score). |
Up to approximately 82 months
|
|
Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
Tidsramme: Baseline and up to approximately 82 months
|
The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The change from baseline in FACT-G total score will be reported. |
Baseline and up to approximately 82 months
|
|
Time to Deterioration (TTD) in FACT-G Total Score
Tidsramme: Up to approximately 82 months
|
The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. TTD in FACT-G total score will be reported. |
Up to approximately 82 months
|
|
Overall Improvement in FACT-G Total Score
Tidsramme: Up to approximately 82 months
|
The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The overall improvement in FACT-G total score will be reported. |
Up to approximately 82 months
|
|
Time to Prostate-specific Antigen (PSA) Progression
Tidsramme: Up to approximately 82 months
|
The time to PSA progression is the time from randomization to PSA progression. The PSA progression date is defined as the date of: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR 2) ≥25% increase and ≥2 ng/mL increase from baseline. |
Up to approximately 82 months
|
|
PSA Response Rate
Tidsramme: Up to approximately 82 months
|
The PSA response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. |
Up to approximately 82 months
|
|
Time to First Symptomatic Skeletal-Related Event (TSSRE)
Tidsramme: Up to approximately 82 months
|
TSSRE is the time from randomization to the first symptomatic skeletal-related event defined as: 1. use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. occurrence of spinal cord compression 4. tumor-related orthopedic surgical intervention, whichever occurs first. |
Up to approximately 82 months
|
|
Number of Participants Who Experience an AE
Tidsramme: Up to approximately 82 months
|
An AE is defined as any unfavorable and unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported. |
Up to approximately 82 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 82 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 82 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. desember 2023
Primær fullføring (Antatt)
10. mai 2028
Studiet fullført (Antatt)
2. desember 2030
Datoer for studieregistrering
Først innsendt
13. november 2023
Først innsendt som oppfylte QC-kriteriene
13. november 2023
Først lagt ut (Faktiske)
18. november 2023
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Prostatiske neoplasmer
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Polysykliske forbindelser
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Steroider, fluorert
- Gravadienetrioler
- Gravadienedioler
- Androstenes
- Androstanes
- Gravidiones
- Gravide
- 11-hydroksykortikosteroider
- Hydroksykortikosteroider
- Adrenal cortex hormoner
- 17-hydroksykortikosteroider
- Abirateronacetat
- Deksametason
- Prednison
- Hydrokortison
- Fludrokortisonacetat
- Enzalutamid
Andre studie-ID-numre
- 5684-004
- MK-5684-004 (Annen identifikator: MSD)
- jRCT2031240030 (Registeridentifikator: Japan Registry of Clinical Trial (jRCT))
- U1111-1288-5002 (Registeridentifikator: UTN)
- 2023-504957-11-00 (Registeridentifikator: EU CT)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .