EORTC-1532-GUCG

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A phase 2 Randomized Open-Label Study of Oral darolutamide (ODM-201) vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in Men with Hormone Naive Prostate Cancer

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 01-Dec-2017
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 250 - All Groups: 250
Treatment	Drug Goserelin, Triptorelin, Leuprorelin, Degarelix, ODM-201
Study Staff	Bertrand Tombal (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels Hazal Erkol (Data 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 Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Joanna Krzystyniak (Clinical Operations Manager) , EORTC Headquarters, Brussels Belma Malanda (Project Manager) , EORTC Headquarters, Brussels Barbara Ogrodniczak (Junior Clinical Operations Manager) , , Miguel Remis (Lead CRA) , EORTC Headquarters, Brussels Lucy Sepulveda (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Jelle Stans (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 DEUTSCHE URO-ONKOLOGEN E.V.
Recruiting centers	Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette (Torino, Italy) CHU Mont Godinne - UCL Namur (Yvoir, Belgium) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Fundacion Instituto Valenciano De Oncologia (Valencia, Spain) Gustave Roussy (VILLEJUIF CEDEX, France) Hopital Universitaires Erasme (Brussels, Belgium) Hospital Universitario Ramon y Cajal (Madrid, Spain) Hospital Universitario Virgen De La Victoria (Malaga, 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) National Cancer Institute - Cairo (Cairo, Egypt) Universitair Ziekenhuis Gent (Gent, Belgium)
Protocol summary	http://clinicaltrials.gov/study/NCT02972060
NCT number	NCT02972060
EudraCT	2016-004334-17
Financial Support	Educational Grant