Study

EORTC-1532-GUCG

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 Back to result

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
  • Belma Malanda (Project Manager), EORTC Headquarters, Brussels
  • Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
  • Catherine Fortpied (Statistician), EORTC Headquarters, Brussels
  • Jammbe Musoro (Statistician), EORTC Headquarters, Brussels
  • Joanna Krzystyniak (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Elizangela Fonseca (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Bart Meulemans (Clinical Data Expert), EORTC Headquarters, Brussels
  • Laurens Vinckier (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Jelle Stans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Miguel Remis (Lead CRA), EORTC Headquarters, Brussels
  • Lucy Sepulveda (Regulatory Affairs Administrator), 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)
  • HUB-Hopital 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