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

• Status: Active, not recruiting
• Trial end date: 2027-09-01

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)

• Phase: Phase 3

Details

• Lead Sponsor: UNICANCER
• Collaborator: Astellas Pharma Inc
• Treatments: Leuprolide