Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
Condition(s) studied
Investigational drug(s) / intervention(s)
Leuprorelin Acetate: Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months
Study summary
PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence.
SECONDARY OBJECTIVE(S):
* PSA evolution
* Evaluation of testosterone level
* Specific survival
* Overall survival
* Tolerance
* Quality of life (QLQ-C30 questionnaires)
Eligibility
Primary outcome measure(s)
- The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy. — The principal criterion will be evaluated 12 years after the inclusion of the first patient.
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinique Victor Pauchet | Amiens | France | |
| Chu Besancon | Besançon | France | |
| Chu Bordeaux- Hopital Pellegrin | Bordeaux | France | |
| Institut Bergonie | Bordeaux | France | |
| Chru de Brest | Brest | France | |
| Hopital Henri Mondor | Créteil | France | |
| Chu Bocage | Dijon | France | |
| Centre Hospitalier Departemental | La Roche-sur-Yon | France | |
| Chru Lille | Lille | France | |
| Chu Limoges | Limoges | France | |
| Hopital Edouard Herriot | Lyon | France | |
| Institut Paoli Calmettes | Marseille | France | |
| Hopital Nord | Marseille | France | |
| Clinique Beausoleil | Montpellier | France | |
| Hopital Lapeyronie | Montpellier | France | |
| Chu de Nancy | Nancy | France | |
| Chu Nantes | Nantes | France | |
| Chu Pasteur | Nice | France | |
| Chu Caremeau | Nîmes | France | |
| Hopital Saint Louis | Paris | France | |
| Hopital Cochin | Paris | France | |
| Institut Mutualiste Montsouris | Paris | France | |
| HEGP | Paris | France | |
| Hopital Tenon | Paris | France | |
| Hopital Pitie Salpetriere | Paris | France | |
| Chu La Miletrie | Poitiers | France | |
| Institut Jean Godinot | Reims | France | |
| Chu Pontchaillou | Rennes | France | |
| Hopital Charles Nicolle | Rouen | France | |
| Centre Hopsitalier Prive - Polyclinique Du Littoral | Saint-Brieuc | France | |
| Clinique Mutualiste | Saint-Etienne | France | |
| Chu Strasbourg | Strasbourg | France | |
| Hopitaux Civils de Colmar | Strasbourg | France | |
| Hopital Foch | Suresnes | France | |
| Chu Rangueil | Toulouse | France |
More UNICANCER trials in France
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 NCT01442246 on ClinicalTrials.gov ↗ ← All trials in France