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

Inclusion criteria

• Patients who have received the information leaflet and signed the consent form
• ≥18 years of age with a life expectancy of at least 10 years
• Performance Status (ECOG) ≤2
• Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion
• Histologically confirmed prostatic adenocarcinoma
• 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
• Postoperative PSA <0.1 ng/mL (dosage perform within 2 months after surgery)
• Neutrophils ≥1500/mm³, platelets ≥100000/mm³
• 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)
• Patients affiliated to a social security scheme

Exclusion criteria

• Previous treatments for prostatic adenocarcinoma (HT or orchiectomy or CT)
• 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
• 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
• Incompatible concomitant treatment(s)
• Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®
• Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
• Persons deprived of their freedom or under supervision (including guardianship),
• Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days