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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 Recruiting
Dates Date of activation: 20-Oct-2015
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 Marion Bettega (Clinical Operations Assistant) marion.bettega (at), EORTC Headquarters, Brussels
Cherelle Clarke (Regulatory Affairs Administrator) cherelle.clarke (at), EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) beatrice.fournier (at), EORTC Headquarters, Brussels
Joanna Krzystyniak (Clinical Operations Manager) joanna.krzystyniak (at), EORTC Headquarters, Brussels
Hafida Lmalem (Imaging Officer) hafida.lmalem (at), EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) livia.meirsman (at), EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) sara.meloen (at), EORTC Headquarters, Brussels
Carla Nell (Junior Clinical Operations Manager) carla.nell (at), EORTC Headquarters, Brussels
Anouk Neven (Statistician) anouk.neven (at), EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) gilles.sarlet (at), EORTC Headquarters, Brussels
Delphine Sartori (Imaging DM) delphine.sartori (at), EORTC Headquarters, Brussels
Nabila Sebti (Data Manager) nabila.sebti (at), EORTC Headquarters, Brussels
Carmen Sobrino (Lead CRA) carmen.sobrino (at), EORTC Headquarters, Brussels
Jelle Stans (Regulatory Affairs Manager) jelle.stans (at), EORTC Headquarters, Brussels
Carla Sureda (Junior Clinical Operations Manager) carla.sureda (at), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Leen Wijnen (Imaging DM) leen.wijnen (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
Groupe d'Etude des Tumeurs Uro-Genitales
Cancer Trials Ireland / ICORG
Canadian Urologic Oncology Group
Grupo Latino Americano de Investigações Clínicas em Oncologia / Latin American Cooperative Oncology Group
Academic and Community Cancer Research United
Recruiting centers AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium)
Akershus University Hospital (Lorenskog, Norway)
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Nimes - Hopital Caremeau (Nimes, France)
Centre Francois Baclesse (CLCC) (Caen, 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)
Chuq-Pavillon Hotel-Dieu De Quebec (Quebec, Canada)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Complejo Hospitalario de Navarra (Pamplona, Spain)
Cork University Hospital (Cork, Ireland)
Corporacio Sanitaria Parc Tauli (Sabadell Barcelona, Spain)
Gustave Roussy (Villejuif, France)
Hopital Universitaire Brugmann (Brussels, Belgium)
Hopital Universitaires Erasme (Brussels, Belgium)
Hopitaux Universitaires de Strasbourg - Hôpital civil (Strasbourg, France)
Hospital Clinic Universitari de Barcelona (Barcelona, Spain)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital Del Mar (Barcelona, Spain)
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 (Salamanca, Spain)
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
Inselspital (Bern, Switzerland)
Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, France)
Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France)
Institut du Cancer de Montpellier (Montpellier, France)
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)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Ospedale B. Ramazzini (Carpi, Italy)
Rigshospitalet (Copenhagen, Denmark)
Soerlandet Sykehus-Kristiansand (Kristiansand, Norway)
St. Vincent'S University Hospital (Dublin, Ireland)
Stavanger University Hospital (Stavanger, Norway)
Tallaght University Hospital (Dublin , Ireland)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Hospital of North Norway (Tromsoe, Norway)
Centers to be activated CHRU de Besancon - Hopital Jean Minjoz (Besancon, France)
CHU de Lyon - Hopital Lyon Sud (Pierre-Benite (Lyon), France)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont (Sherbrooke, Canada)
Centro Pesquisas Oncologicas (Florianopolis, Brazil)
Centro de Estudos e Pesquisa Hematologia e Oncologia (Santo Andre, Brazil)
Centro de Tratamentos de Tumores Botafogo (Rio de Janeiro, Brazil)
Clínica Oncológica - CLION (Salvador, Brazil)
Hamilton And District Urology Association (Hamilton, Ontario, Canada)
Hospital Alemao Oswaldo Cruz (Sao Paolo, Brazil)
Hospital Beneficencia Portuguesa (Sao Paolo, Brazil)
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 (Sao Paulo, Brazil)
Hospital Universitario Virgen De La Victoria (Malaga, Spain)
Hospital Universitario de Brasilia (Brasilia, Brazil)
Hospital de Caridade de Ijui (Ijui, Brazil)
Hospital do Cancer de Pernambuco (Recife, Brazil)
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital (Cottingham, United Kingdom)
Instituto Brasileiro de Controle do Câncer (Sao Paulo, Brazil)
Instituto do Cancer do Estado de Sao Paulo (Sao Paulo, Brazil)
Odette Cancer Centre - Sunnybrook Health Sciences Centre (Toronto, Canada)
Oncocentro (Fortaleza, Brazil)
Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
Saint John Regional Hospital (Saint John, New Brunswick, Canada)
San Camillo Forlanini Hospitals (Roma, Italy)
Santa Casa da Misericórdia de Porto Alegre- Santa Rita Hospital (Porto Alegre, Brazil)
St. Olavs Hospital, Trondheim University Hospital (Trondheim, Norway)
The Royal Surrey County Hospital NHS Foundation Trust (Guildford, United Kingdom)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
United Lincolnshire Hospitals NHS Trust-Lincoln County Hospital (Lincoln, United Kingdom)
University Health Network - Oci / Princess Margaret Hospital (Toronto, Canada)
Protocol summary
NCT number NCT02194842
EudraCT 2014-001787-36