Trial | NCT01442246  Report issue

Title

Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
Phase III Randomised Trial to Evaluate the Benefit of Adjuvant Hormonal Treatment With Leuprorelin Acetate (Eligard® 45 mg) for 24 Months After Radical Prostatectomy in Patients With High Risk of Recurrence.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    leuprolide ...

  • Study Participants

    700
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)
Study Started
Jul 31
2011
Primary Completion
Sep 30
2027
Anticipated
Study Completion
Sep 30
2027
Anticipated
Last Update
Jun 22
2023

Drug Leuprorelin Acetate

Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months

  • Other names: Eligard®

Adjuvant treatment Experimental

Leuproreline acetate

Surveillance No Intervention

Surveillance

Criteria 

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
No Results Posted