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Active, not recruiting Phase 3

Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.

NCT01442246 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Phase 3
Started
2011-07
Last updated
2024-09-19

Condition(s) studied

Metastases

Investigational drug(s) / intervention(s)

Leuprorelin Acetate →

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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients who have received the information leaflet and signed the consent form 2. ≥18 years of age with a life expectancy of at least 10 years 3. Performance Status (ECOG) ≤2 4. Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion 5. Histologically confirmed prostatic adenocarcinoma 6. Patients R0, N0 or Nx or N+ (≤ 2 nodes among nodes removed), M0 and with at least one of the following criteria: * postoperative Gleason score \>7 * postoperative Gleason score =7 with the presence of high-grade Gleason patterns * pT3b patients 7. Postoperative PSA \<0.1 ng/mL (dosage perform within 2 months after surgery) 8. Neutrophils ≥1500/mm³, platelets ≥100000/mm³ 9. Bilirubin ≤ upper normal limit (this will not apply to subjects with Gilbert's syndrome, persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology); ASAT and ALAT ≤1.5 times upper normal limit; Creatinine \<140 µmol/l (or clearance \>60 mL/min) 10. Patients affiliated to a social security scheme Exclusion Criteria: 1. Previous treatments for prostatic adenocarcinoma (HT or orchiectomy or CT) 2. Presence of metastases: * positive bone scintigraphy, including Patients with medullary compression and/or * abdominal-pelvic CT scan or MRI showing lymph node and/or visceral involvement 3. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission 4. Incompatible concomitant treatment(s) 5. Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard® 6. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial 7. Persons deprived of their freedom or under supervision (including guardianship), 8. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days

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)

FacilityCityRegionStatus
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
Official registry record

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