Clinical Trial Details
EORTC-1545-GUCG
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Randomised phase 3 trial of Enzalutamide in Androgen Deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer.
| Trial Status | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 10-Oct-2017 Date Step1 close: 06-Jul-2018 |
| Data management at EORTC | No |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | EORTC Groups: 200 - All Groups: 800 |
| Treatment |
Radiotherapy, Drug Enzalutamide, NILUTAMIDE, Flutamide |
| Study Staff |
Valerie Fonteyne (Study Coordinator) , Universitair Ziekenhuis Gent, Gent Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Joanna Krzystyniak (Clinical Operations Manager) , EORTC Headquarters, Brussels Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels Miguel Remis (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Nathalie Ropson (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels Gaetan de Schaetzen (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels |
| Type of cancer | Prostate |
| Participating groups |
EORTC Genito-Urinary Cancers Group Cancer Trials Ireland The Australian and New Zealand Urogenital and Prostate |
| Recruiting centers |
AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) Hospital Universitario Donostia (Donostia-Gipuzkoa, Spain) Hospital Universitario de Salamanca - Hosp Virgen De la Vega (Salamanca, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) Salzburger Landeskliniken - Universitätsklinikum Salzburg (Salzburg, Austria) The Institute Of Oncology (Ljubljana, Slovenia) |
| Protocol summary | http://clinicaltrials.gov/study/NCT02446444 |
| NCT number | NCT02446444 |
| EudraCT | 2014-003191-23 |
| Financial Support | Educational Grant |
