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

Study documentation

Trial Status Recruiting
Dates Date of activation: 01-Dec-2017
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 250
Treatment Drug
ODM-201, Leuprorelin acetate, Goserelin acetate, Triptorelin acetate, Triptorelin pamoate, Degarelix acetate
Study Staff Bertrand Tombal (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels
Kimberley Ceulemans (Lead CRA) kimberley.ceulemans (at), EORTC Headquarters, Brussels
Laurence Collette (Statistician) laurence.collette (at), EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) beatrice.fournier (at), EORTC Headquarters, Brussels
Claire Gandilhon (Clinical Operations Assistant) claire.gandilhon (at), EORTC Headquarters, Brussels
Frederik Janssens (Clinical Research Associate/Monitor) frederik.janssens (at), EORTC Headquarters, Brussels
Joanna Krzystyniak (Junior Clinical Operations Manager) joanna.krzystyniak (at), EORTC Headquarters, Brussels
Joana Mendes (Regulatory Affairs Administrator) joana.mendes (at), EORTC Headquarters, Brussels
Carla Nell (Clinical Operations Assistant) carla.nell (at), EORTC Headquarters, Brussels
Bassem Osmani (Data Manager) bassem.osmani (at), EORTC Headquarters, Brussels
Miguel Remis (Clinical Research Associate/Monitor) miguel.remis (at), EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) gilles.sarlet (at), EORTC Headquarters, Brussels
Lucia Senna (Clinical Operations Assistant) lucia.senna (at), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Zineb Wadid (Lead CRA) zineb.wadid (at), EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) christine.debalincourt (at), EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) gaetan.deschaetzen (at), EORTC Headquarters, Brussels
Type of cancer Prostate
Participating groups EORTC Genito-Urinary Cancers Group
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, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Gustave Roussy (Villejuif, France)
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
Hospital Universitario Virgen De La Victoria (Malaga, Spain)
Hospital Universitario de Salamanca (Salamanca, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
Instituto Valenciano De Oncologia (Valencia, Spain)
Medical University of Graz (Graz, Austria)
National Cancer Institute (Cairo, Egypt)
Universitair Ziekenhuis Gent (Gent, Belgium)
Centers to be activated AO Ospedale di Circolo di Busto Arsizio (Busto Arsizio, Italy)
Ain Shams University Hospital (Cairo, Egypt)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, Italy)
Ospedale B. Ramazzini (Carpi, Italy)
Ospedale San Carlo Borromeo (Milano, Italy)
San Camillo Forlanini Hospitals (Roma, Italy)
San Camillo Forlanini Hospitals (Roma, Italy)
Protocol summary
NCT number NCT02972060
EudraCT 2016-004334-17