Study
EORTC-2238-GUCG
Intermittent Androgen deprivation Therapy in the era of AR pathway inhibitors; a phase 3 pragmatic randomized trial.
Trial Status
Recruiting
Dates
Date of activation: 23-May-2025
Data management at EORTC
Yes
Design
Phase 3
Randomized open label
Randomized open label
Treatment
Drug
Goserelin, Abiraterone, Triptorelin, Leuprorelin, Enzalutamide, Degarelix, Apalutamide, Darolutamide, Relugolix, Akeega
Goserelin, Abiraterone, Triptorelin, Leuprorelin, Enzalutamide, Degarelix, Apalutamide, Darolutamide, Relugolix, Akeega
Study Staff
- Bertrand Tombal (Study Coordinator), Cliniques Universitaires Saint-Luc, Brussels
- Silke Gillessen (Study Co-Coordinator), Oncology Institute of Southern Switzerland - Ospedale San Giovanni, Bellinzona
- Guillaume Grisay (Y-ECI Coordinator), CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont, Haine-Saint-Paul
- Fabio Turco (Y-ECI Coordinator), Oncology Institute of Southern Switzerland - Ospedale San Giovanni, Bellinzona
- Egle Venslovaite (Project Manager), EORTC Headquarters, Brussels
- Bert Dhondt (Clinical Research Physician), EORTC Headquarters, Brussels
- Beatrice Fournier (Clinical Scientist), EORTC Headquarters, Brussels
- Olga Basova (Statistician), EORTC Headquarters, Brussels
- Jammbe Musoro (Statistician), EORTC Headquarters, Brussels
- Jerome Rapion (Statistical Analyst), EORTC Headquarters, Brussels
- Cedric Mallien (TR Scientist), EORTC Headquarters, Brussels
- Joanna Krzystyniak (Clinical Operations Manager), EORTC Headquarters, Brussels
- Sophie Roulet (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
- Kacper Sierocki (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
- Lore Meelberghs (Data Manager), EORTC Headquarters, Brussels
- Bart Meulemans (Data Manager), EORTC Headquarters, Brussels
- Tim Verbiest (Data Manager), EORTC Headquarters, Brussels
- Peter De Burghgraeve (Study Designer), EORTC Headquarters, Brussels
- Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Gilles Sarlet (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Katheline Vander Heggen (Junior RAM), EORTC Headquarters, Brussels
- Christine Bourguignon (Clinical Operations Assistant), EORTC Headquarters, Brussels
- Stephane Lejeune (International Affairs and Policies Manager), EORTC Headquarters, Brussels
- Ahu Alanya (QoL Specialist), EORTC Headquarters, Brussels
Type of cancer
- Prostate
Participating groups
- EORTC Genito-Urinary Cancers Group
- Swiss Cancer Institute (formerly Schweizerisches Arbeitsgemeinschaft Klin. Krebsforschung)
- Groupe d'Etude des Tumeurs Uro-Genitales
- Spanish Oncology Genito-Urinary Group
- Cancer Trials Ireland
Recruiting centers
- APHP Centre - Univ de Paris Cite - Hopital Europeen Georges Pompidou (PARIS, France)
- APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France)
- Beacon Hospital (Dublin 18, Ireland)
- Beaumont Hospital (Dublin, Ireland)
- Brust-Zentrum AG Zurich (Zurich, Switzerland)
- CH de La Cote Basque - Saint Leon (Bayonne, France)
- CHR d'Orleans - Hopital De La Source (ORLEANS CEDEX 2, France)
- CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
- CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
- CHU de Lyon - Hopital Edouard Herriot (LYON, France)
- CHU de Lyon - Hopital Lyon Sud (PIERRE BENITE CEDEX, France)
- CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE, France)
- CHU de Tours - Hopital Bretonneau (Tours, France)
- Cantonal Hospital Olten (Olten, Switzerland)
- Centre Eugene Marquis (RENNES CEDEX, France)
- Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France)
- Centre Leon Berard (Lyon, France)
- Clinique La Croix Du Sud (Quint-Fonsegrives, France)
- Clinique Pasteur-Lanroze (BREST, France)
- Cliniques Universitaires Saint-Luc (Brussels, Belgium)
- Cork University Hospital (Cork, Ireland)
- Grand Hopital de Charleroi - Site Les Viviers (Gilly, Belgium)
- Groupe Hosp. St Vincent -Clinique Ste Anne (Strasbourg, France)
- Groupe Hospitalier Mutualiste de Grenoble-Institut Daniel Hollard (Grenoble, France)
- Groupe Hospitalier Paris Saint-Joseph - Hopital Saint Joseph (Paris, France)
- Gustave Roussy (VILLEJUIF CEDEX, France)
- HOCH Health Ostschweiz-Kantonsspital St Gallen (St Gallen, Switzerland)
- Hirslanden Klinik-Tumor Zentrum Aarau (Aarau, Switzerland)
- Hopitaux Universitaires de Strasbourg - Hôpital civil (STRASBOURG CEDEX, France)
- Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
- Hospital Clinic de Barcelona (Barcelona, Spain)
- Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
- Hospital Del Mar (Barcelona, Spain)
- Hospital Universitari Son Espases (Palma De Mallorca, Spain)
- Hospital Universitario 12 De Octubre (Madrid, Spain)
- Hospital Universitario Central De Asturias (Oviedo, Spain)
- Hospital Universitario De Cruces (Barakaldo (Bizkaia), Spain)
- Hospital Universitario Marques De Valdecilla (Santander, Spain)
- Hospital Universitario Puerta De Hierro (Majadahonda, Spain)
- Hospital Universitario Ramon y Cajal (Madrid, Spain)
- Hospital Universitario Regional de Malaga (Malaga, Spain)
- Hospital Universitario Reina Sofia (Cordoba, Spain)
- Hospital Universitario San Carlos (Madrid, Spain)
- Hospital Universitario Virgen De La Victoria (Malaga, Spain)
- Hospital Universitario de La Princesa (Madrid, Spain)
- Hospital Universitario de Navarra (Pamplona, Spain)
- Institut Curie- Hopital de Paris (PARIS CEDEX 05, France)
- Institut Godinot (REIMS CEDEX, France)
- Institut Mutualiste Montsouris (Paris, France)
- Institut Paoli-Calmettes (MARSEILLE CEDEX 09, France)
- Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France)
- Kantonsspital Frauenfeld- Breast Unit Thurgau (Frauenfeld, Switzerland)
- Kantonsspital Graubuenden (Chur, Switzerland)
- Klinicki bolnicki Centar Sestre Milosrdnice - (Grad Zagreb, Croatia)
- Les Hopitaux Civils de Colmar (COLMAR CEDEX, France)
- Luzerner Kantonsspital (Luzern, Switzerland)
- Mater Misericordia University Hospital (Dublin, Ireland)
- Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
- Parc Tauli Hospital Universitari (Sabadell Barcelona, Spain)
- Rigshospitalet (Copenhagen, Denmark)
- Spital STS AG Thun (Thun, Switzerland)
- St. Claraspital (Basel, Switzerland)
- St. James'S Hospital (Dublin, Ireland)
- Stadtspital Zurich Triemli (Zurich, Switzerland)
- Tallaght University Hospital (Dublin, Ireland)
- U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
- UniversitaetsSpital Zurich (Zurich, Switzerland)
- Universitair Ziekenhuis Gent (Gent, Belgium)
- University Hospital Galway (Galway, Ireland)
- University Hospital Limerick (Limerick, Ireland)
- University Hospital Virgen del Rocio (Sevilla, Spain)
Centers to be activated
- APHP - Hop. Univ. Henri Mondor (Creteil, France)
- AZ Delta - Campus Rumbeke (Roeselare, Belgium)
- Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy)
- CHU de Brest (Brest, France)
- CLCC - Jean Perrin (CLERMONT FERRAND , France)
- Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
- Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
- Centre Oscar Lambret (LILLE CEDEX, France)
- Clinique Hartmann (Neuilly-Sur-Seine, France)
- Fakultni nemocnine Brno - Univ. Hospital Brno (Brno, Czech Republic)
- Heilig Hartziekenhuis Lier (Lier, Belgium)
- Herlev Hospital - University Copenhagen (Herlev, Denmark)
- Hospital Clinico Universitario De Valladolid (Valladolid, Spain)
- Hospital General Universitario Gregorio Maranon (Madrid, Spain)
- Hospital Riviera-Chablais (Rennaz, Switzerland)
- Hospital San Pedro de Alcantara (Caceres, Spain)
- Hospital Universitario Lucus Augusti (Lugo, Spain)
- Hospital da Luz - Lisboa (Lisboa, Portugal)
- Hospital prive du Confluent - Centre Catherine de Sienne (NANTES CEDEX 2, France)
- ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
- IRCCS-Regina Elena National Cancer Center (Roma, Italy)
- Institut Bergonie (Bordeaux, France)
- Institut Jules Bordet (Anderlecht, Belgium)
- Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France)
- 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)
- Istituto Europeo di Oncologia (Milano, Italy)
- Kantonsspital Baden (Baden, Switzerland)
- Kantonsspital Winterthur (Winterthur, Switzerland)
- Mater Private Hospital (Dublin 7, Ireland)
- Medisprof Cancer Center srl (Cluj-Napoca, Romania)
- Oncomed S.R.L Hospital (Timisoara, Romania)
- Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola (Roma, Italy)
- Ospedale P. Pederzoli Casa Di Cura Privata (Peschiera Del Garda, Italy)
- Santa Maria della Misericordia Hospital (Perugia, Italy)
- St. Vincent'S University Hospital (Dublin 4, Ireland)
- The Institute Of Oncology (Ljubljana, Slovenia)
- Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
- University Hospital Of Olomouc (Olomouc, Czech Republic)
Protocol summary
NCT number
NCT05974774