Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

885

Participants

Timeline

Start Date

September 25, 2017

Primary Completion Date

August 23, 2023

Study Completion Date

June 30, 2026

Conditions
Prostate Cancer
Interventions
DRUG

Degarelix

a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy

DRUG

approved GnRH agonist

A non-steroidal anti-androgen (e. g. flutamide, bicalutamide) will be given orally one week before the first injection of the GnRH agonist and will be continued for no longer than 8 weeks to protect against flare.Dose may vary due to availability of different brand names and pharmaceutical forms The start of antiandrogen must be registered as day 1 of treatment in the GnRH agonist arm.

RADIATION

Radiotherapy

.As the study investigates the effect of two drugs given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT)

Trial Locations (39)

1000

Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet, Brussels

1070

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme, Brussels

1090

Universitair Ziekenhuis Brussel, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2100

University Hospitals Copenhagen - Rigshospitalet, Copenhagen

2610

Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus, Wilrijk

3010

Inselspital, Bern

5000

CHU Ucl Namur - Site Sainte-Elisabeth, Namur

6200

Centre de radiotherapie Marie Curie, Arras

6500

Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli, Bellinzona

7100

Hopital De Jolimont, Haine-Saint-Paul

8500

AZ Groeninge Kortrijk - Campus Kennedylaan, Kortrijk

12200

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin

14004

Hospital Universitario Reina Sofia, Córdoba

28922

Fundacion Hospital Alcorcon, Alcorcón

30202

Hospital General Universitario Santa Lucia, Cartagena

35010

Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria

35760

Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire

36312

Complejo Hospitalario Universitario de Vigo -CHUVI - Hospital Alvaro Cunqueiro, Vigo

37007

Hospital Universitario de Salamanca, Salamanca

38043

CHU de Grenoble - La Tronche - Hôpital A. Michallon, Grenoble

39120

Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik, Magdeburg

44805

Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau, Nantes

47014

AUSL Romagna - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48014

Clinica IMQ Zorrotzaurre, Bilbao

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

62660

Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie, Beuvry

64100

Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque, Bayonne

69008

Centre Leon Berard, Lyon

75651

Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere, Paris

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80090

Clinique de l'Europe, Amiens

BP27617

Clinique Pasteur-Toulouse-Atrium, Toulouse

08916

Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia), Barcelona

Unknown

Complejo Hospitalario A, Pamplona

Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie, Geneva

08208

Corporacio Sanitaria Parc Tauli, Sabadell

08227

Hospital Consorci Sanitari De Terrassa, Terrassa

NG5 1PB

Nottingham University Hospitals NHS Trust - City Hospital, Nottingham

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK