drugset / Trial / NCT01442246
Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
RandomizedParallel-groupOpen-labelTreatment
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)
Timeline
- Start
- 2011-07
- Primary completion
- 2027-09
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | 45 mg | — |