Clinical Trial

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

Active, Not Recruiting Phase 3
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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)
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2011-09-27; most recent amendment 2024-09-17.
Status change: Recruiting → Active, Not Recruiting 2018-05-06
Status change: Active, Not Recruiting → Recruiting 2016-06-20
Trial Details
NCT Number NCT01442246
Lead Sponsor UNICANCER
Collaborators: Astellas Pharma Inc
Conditions Metastases
Enrollment 700 participants
Start Date 2011-07
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2024-09-19