EORTC-1333-GUCG

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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

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 Sonja Boes (Clinical Research Associate/Monitor) , , Luminita Copaceanu (Lead CRA) , EORTC Headquarters, Brussels Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels Laura Decubber (Imaging DM) , 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 Annika Lux (Data Manager) , EORTC Headquarters, Brussels Salvatore Mazza (Lead CRA) , EORTC Headquarters, Brussels Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Barbara Ogrodniczak (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Jerome Rapion (Statistical Analyst) , 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) Centre de sante et de services sociaux de Chicoutimi (Chicoutimi, Quebec, Canada) 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) Hamilton And District Urology Association (Hamilton, Ontario, Canada) Hopital Universitaire Brugmann (Brussels, Belgium) Hopital Universitaires Erasme (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 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) 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
Financial Support	Educational Grant