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
Condition(s) studied
Investigational drug(s) / intervention(s)
Degarelix: a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy
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.
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)
Study summary
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy.
Secondary objectives include:
* documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline;
* documentation of side effects and quality of life, I-PSS and urinary tract infections;
* assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.
Eligibility
Primary outcome measure(s)
- Progression free survival — through study completion, an average of 1 year
The primary endpoint is progression-free survival defined as the time in days from randomization to death, clinical or biochemical progression, whichever comes first. Where * PSA progression based on Phoenix definition, i.e. a rise by 2 ng/mL or more above the nadir PSA (Ref. 17) confirmed by a second value measured minimum 3 months later * Clinical progression is defined as onset of obstructive symptoms requiring local treatment and demonstrated to be caused by cancer progression or evidence of metastases detected by clinical symptoms and confirmed by imaging * Start of another line of systemic therapy in absence of progression * Death due to any cause
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet | Brussels | Belgium | |
| Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme | Brussels | Belgium | |
| Universitair Ziekenhuis Brussel | Brussels | Belgium | |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| Hopital De Jolimont | Haine-Saint-Paul | Belgium | |
| AZ Groeninge Kortrijk - Campus Kennedylaan | Kortrijk | Belgium | |
| CHU Ucl Namur - Site Sainte-Elisabeth | Namur | Belgium | |
| Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus | Wilrijk | Belgium | |
| University Hospitals Copenhagen - Rigshospitalet | Copenhagen | Denmark | |
| Clinique de l'Europe | Amiens | France | |
| Centre de radiotherapie Marie Curie | Arras | France | |
| Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque | Bayonne | France | |
| Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie | Beuvry | France | |
| CHU de Grenoble - La Tronche - Hôpital A. Michallon | Grenoble | France | |
| Centre Leon Berard | Lyon | France | |
| Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau | Nantes | France | |
| Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere | Paris | France | |
| Centre Hospitalier Privé Saint-Grégoire | Saint-Grégoire | France | |
| Clinique Pasteur-Toulouse-Atrium | Toulouse | France | |
| Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | Germany | |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Germany | |
| Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik | Magdeburg | Germany | |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | |
| AUSL Romagna - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Italy | |
| Fundacion Hospital Alcorcon | Alcorcón | Spain | |
| Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) | Barcelona | Spain | |
| Clinica IMQ Zorrotzaurre | Bilbao | Spain | |
| Hospital General Universitario Santa Lucia | Cartagena | Spain | |
| Hospital Universitario Reina Sofia | Córdoba | Spain | |
| Hospital Universitario de Gran Canaria Doctor Negrin | Las Palmas de Gran Canaria | Spain | |
| Complejo Hospitalario A | Pamplona | Spain | |
| Corporacio Sanitaria Parc Tauli | Sabadell | Spain | |
| Hospital Universitario de Salamanca | Salamanca | Spain | |
| Hospital Consorci Sanitari De Terrassa | Terrassa | Spain | |
| Complejo Hospitalario Universitario de Vigo -CHUVI - Hospital Alvaro Cunqueiro | Vigo | Spain | |
| Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli | Bellinzona | Switzerland | |
| Inselspital | Bern | Switzerland | |
| Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie | Geneva | Switzerland | |
| Nottingham University Hospitals NHS Trust - City Hospital | Nottingham | United Kingdom |
More European Organisation for Research and Treatment of Cancer - EORTC trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02799706 on ClinicalTrials.gov ↗ ← All trials in Belgium