Clinical Trial Details
EORTC-1201-GUCG-ROG
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A prospective randomised phase III study of androgen deprivation therapy (+/- docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.
| Trial Status | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 05-Jan-2015 Date Step1 close: 11-Apr-2019 |
| Data management at EORTC | No |
| Design |
Phase 3 Not randomized / N.A. |
| Targeted Sample size | EORTC Groups: 300 - All Groups: 916 |
| Treatment |
Radiotherapy, Drug Abiraterone |
| Study Staff |
Dominik Berthold (Study Coordinator) , Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Coreen Corning (QART Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Research Physician) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Joanna Krzystyniak (Clinical Operations Manager) , EORTC Headquarters, Brussels Hafida Lmalem (Data Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels Davide Passariello (Project Manager) , EORTC Headquarters, Brussels Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Gaetan de Schaetzen (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels |
| Type of cancer | Prostate |
| Participating groups |
EORTC Genito-Urinary Cancers Group EORTC Radiation Oncology Group UNICANCER Groupe d'Etude des Tumeurs Uro-Genitales |
| Recruiting centers |
AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) AZ Groeninge Kortrijk - Campus Vercruysselaan (Kortrijk, Belgium) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Institut Jules Bordet (Anderlecht, Belgium) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) |
| Protocol summary | http://clinicaltrials.gov/study/NCT01957436 |
| NCT number | NCT01957436 |
| EudraCT | 2012-000142-35 |
| Financial Support | Educational Grant |
