Study

EORTC-1333-GUCG

A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.

Study documentation Back to result

Trial Status

Closed to Patient Entry

Dates

Date of activation: 20-Oct-2015
Date Step1 close: 03-Mar-2023

Data management at EORTC

Yes

Design

Phase 3
Randomized open label

Targeted Sample size

EORTC Groups: 464 - All Groups: 560

Treatment

Drug
Enzalutamide, Radium Ra223 dichloride

Study Staff

  • Amelie Baudhuin (Clinical Operations Assistant), EORTC Headquarters, Brussels
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Luminita Copaceanu (Lead CRA), EORTC Headquarters, Brussels
  • Peter De Burghgraeve (Data Manager), EORTC Headquarters, Brussels
  • Florence Dujardin (Data Manager), EORTC Headquarters, Brussels
  • Carolina Fernandes (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
  • Joanna Krzystyniak (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Saskia Litiere (Statistician), EORTC Headquarters, Brussels
  • Hafida Lmalem (Imaging Officer), EORTC Headquarters, Brussels
  • Cedric Mallien (TR Scientist), EORTC Headquarters, Brussels
  • Salvatore Mazza (Lead CRA), EORTC Headquarters, Brussels
  • Livia Meirsman (Project Manager), EORTC Headquarters, Brussels
  • Bart Meulemans (Data Manager), EORTC Headquarters, Brussels
  • Barbara Ogrodniczak (Junior Clinical Operations Manager), ,
  • Coralie Poncet (Statistician), EORTC Headquarters, Brussels
  • Jerome Rapion (Statistical Analyst), EORTC Headquarters, Brussels
  • Miguel Remis (Lead CRA, Clinical Research Associate/Monitor), EORTC Headquarters, Brussels
  • Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Nabila Sebti (Data Manager), EORTC Headquarters, Brussels
  • Lucy Sepulveda (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
  • Cathy Van de Wiele (Imaging DM), EORTC Headquarters, Brussels
  • Laurens Vinckier (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Zineb Wadid (Lead CRA), EORTC Headquarters, Brussels
  • Leen Wijnen (Imaging DM), 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
  • Groupe d'Etude des Tumeurs Uro-Genitales
  • Cancer Trials Ireland
  • Canadian Urologic Oncology Group
  • Grupo Latino Americano de Investigacoes Clínicas em Oncologia / Latin American Cooperative Oncology Group

Recruiting centers

  • APHP - Hop. Univ. Henri Mondor (Creteil, France)
  • AUSL Modena - Ospedale B. Ramazzini (Carpi, Italy)
  • AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
  • AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium)
  • Akershus University Hospital (Lorenskog, Norway)
  • CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
  • CHU de Nimes - Hopital Caremeau (NIMES CEDEX 9, France)
  • Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France)
  • Centre Hospitalier de l'Université de Montreal (Montreal, Quebec, Canada)
  • Centre Leon Berard (Lyon, France)
  • Centro Pesquisas Oncologicas (Florianopolis, Brazil)
  • Centro de Estudos e Pesquisa Hematologia e Oncologia (Santo Andre, Brazil)
  • Centro de Pesquisa Clinica Sao Lucas (Campinas, Brazil)
  • Centro de Pesquisas Clinicas em Oncologia - Hospital Sao Lucas (Porto Alegre, Brazil)
  • Centro de Tratamentos de Tumores Botafogo (Rio de Janeiro, Brazil)
  • Chuq-Pavillon Hotel-Dieu De Quebec (Quebec, Canada)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • Clínica Oncológica - CLION (Salvador, Brazil)
  • Complejo Hospitalario de Navarra (Pamplona, Spain)
  • Cork University Hospital (Cork, Ireland)
  • Gustave Roussy (VILLEJUIF CEDEX, France)
  • HUB-Hopital Universitaires Erasme (Brussels, Belgium)
  • Hopital Universitaire Brugmann (Brussels, Belgium)
  • Hopitaux Universitaires de Strasbourg - Hôpital civil (STRASBOURG CEDEX, France)
  • Hospital Alemao Oswaldo Cruz (Sao Paolo, Brazil)
  • Hospital Beneficencia Portuguesa (Sao Paolo, Brazil)
  • Hospital Clinic de Barcelona (Barcelona, Spain)
  • Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
  • Hospital Del Mar (Barcelona, Spain)
  • Hospital Erasto Gaertner (Curitiba, Brazil)
  • Hospital Israelita Albert Einsten (Sao Paolo, Brazil)
  • Hospital Moinhos de Vento (Porto Alegre, Brazil)
  • Hospital Paulistano (Sao Paolo, Brazil)
  • Hospital Sirio-Libanes - Centro De Oncologia Asa Sul (Brasilia, Brazil)
  • Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
  • Hospital Universitario QuironSalud (Madrid, Spain)
  • Hospital Universitario Ramon y Cajal (Madrid, Spain)
  • Hospital Universitario de Gran Canaria Doctor Negrin (Las Palmas de Gran Canaria, Spain)
  • Hospital Universitario de La Princesa (Madrid, Spain)
  • Hospital Universitario de Salamanca - Hosp Virgen De la Vega (Salamanca, Spain)
  • Hospital de Amor (Barretos, Brazil)
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
  • Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France)
  • Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France)
  • Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France)
  • Instituto de Medicina Integral Professor Fernando Figueira - IMIP (Recife, Brazil)
  • Istituto Europeo di Oncologia (Milano, Italy)
  • Kantonsspital St Gallen (St Gallen, Switzerland)
  • London Regional Cancer Center (London, Canada)
  • Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
  • NHS - Lincolnshire - Pilgrim Hospital Boston (Boston, United Kingdom)
  • Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
  • Oncocentro (Fortaleza, Brazil)
  • Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
  • Parc Tauli Hospital Universitari (Sabadell Barcelona, Spain)
  • Rigshospitalet (Copenhagen, Denmark)
  • Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
  • Sao Camilo Oncologia - Instituto Brasileiro de Controle do Cancer (Sao Paulo, Brazil)
  • Soerlandet Sykehus-Kristiansand (Kristiansand, Norway)
  • St. Vincent'S University Hospital (Dublin 4, Ireland)
  • Stavanger University Hospital (Stavanger, Norway)
  • Tallaght University Hospital (Dublin, Ireland)
  • The Christie NHS Foundation Trust (Manchester, United Kingdom)
  • U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
  • United Lincolnshire Hospitals NHS Trust-Lincoln County Hospital (Lincoln, United Kingdom)
  • Universidade Federal de Minas Gerais – UFMG (Belo Horizonte, Brazil)
  • UniversitaetsSpital Zurich (Zurich, Switzerland)
  • Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
  • University Hospital of North Norway (Tromsoe, Norway)

Protocol summary

http://clinicaltrials.gov/study/NCT02194842

NCT number

NCT02194842

EudraCT

2014-001787-36