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

Treatment

Drug
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