Trials / Active Not Recruiting
Active Not RecruitingNCT01442246
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.
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leuprorelin Acetate | Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2011-09-28
- Last updated
- 2024-09-19
Locations
35 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01442246. Inclusion in this directory is not an endorsement.