Status:
ACTIVE_NOT_RECRUITING
Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Metastases
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 radic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01442246
Start Date
July 1 2011
End Date
September 1 2027
Last Update
September 19 2024
Active Locations (35)
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1
Clinique Victor Pauchet
Amiens, France, 80000
2
Chu Besancon
Besançon, France, 25030
3
Chu Bordeaux- Hopital Pellegrin
Bordeaux, France, 33000
4
Institut Bergonie
Bordeaux, France, 33076