Spots Global Cancer Trial Database for ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.
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Trial Identification
Brief Title: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.
Official Title: ODM-201 Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Subsequent Treatment With a Taxane: A Multicenter Randomized Double-blind Placebo-controlled Phase II Trial.
Study ID: NCT02933801
Study Description
Brief Summary: The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.
Detailed Description: The treatment of metastatic castration-resistant prostate cancer has evolved rapidly over the past few years. First line treatment with one of the novel antihormonal drugs abiraterone or enzalutamide followed by chemotherapy with docetaxel is now standard of care. If a patient has disease stabilization on chemotherapy he undergoes a watchful waiting period and further treatment is only started at the time of disease progression. This trial tests the immediate use of the novel androgen receptor antagonist ODM-201 as maintenance treatment after chemotherapy aiming at prolonging radiographic progression free survival as compared to watchful waiting. The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Institut Bergonié, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
Centre de lutte contre le cancer Léon Bérard, Lyon, , France
Centre Eugène Marquis, Rennes, , France
European Institute of Oncology (EIO), Milano, , Italy
Istituto Nazionale dei Tumori - IRCCS Fondazione, Milano, , Italy
Istituto Nazionale dei Tumori - IRCCS Fondazione Pascale S.C., Napoli, , Italy
AOU "Maggiore della Carità" di S.C. di Oncologia, Novara, , Italy
AOU San Luigi Gonzaga, Orbassano, , Italy
AO San Camillo and Forlanini Hospitals, Roma, , Italy
Presidio Ospedaliero Santa Chiara, Trento, , Italy
Azienda Ospedaliera Universitaria Integrate Verona (AOUI), Verona, , Italy
Hospital de Torrecárdenas, Almería, , Spain
Hospital Universitario Infanta Cristina, Badajoz, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Consorcio Hospitalario Provincial de Castellon, Castellón De La Plana, , Spain
Hospital Universitario San Cecilio, Granada, , Spain
Hospital Univ. de Guadalajara, Guadalajara, , Spain
Centro Integral Oncológico Clara Campal - Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda, , Spain
Hospital General Universitario Morales Meseguer, Murcia, , Spain
Complejo Hospital Universitario de Santiago de Compostela, Santiago De Compostela, , Spain
Kantonsspital Baden, Baden, , Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Hôpital Fribourg HFR, Fribourg, , Switzerland
Kantonsspital Liestal, Liestal, , Switzerland
Fondazione Oncologia / Oncologia ematologia, Locarno, , Switzerland
Kantonsspital Muensterlingen, Münsterlingen, , Switzerland
Hôpital du Valais (Sion et Martigny), Sion, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Spital STS AG, Thun, , Switzerland
Contact Details
Name: Silke Gillessen, Prof
Affiliation: Cantonal Hospital of St. Gallen
Role: STUDY_CHAIR
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