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

Metastases Clinical Trial

Official title:
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.

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01442246
Study type Interventional
Source UNICANCER
Contact
Status Active, not recruiting
Phase Phase 3
Start date July 2011
Completion date September 2027
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