A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.
- To assess acute and late toxicities in patients with high-risk, locally advanced
- To assess the biochemical-free survival of these patients.
- To assess metastasis-free survival of these patients.
- To assess the overall survival of these patients.
- To assess the molecular characteristics of the tumor before treatment and correlate
OUTLINE: This is a dose-escalation study of everolimus.
Patients undergo radiotherapy to the prostate and seminal vesicles once daily, 5 days a
week, for 7.5 weeks.
Beginning the week before radiotherapy, patients receive oral bicalutamide once daily for 1
month and oral everolimus twice daily for 8.5 weeks. Beginning on the first week of
radiotherapy, patients receive leuprolide acetate subcutaneously every 3 months for 2 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Acute and late toxicities
David Azria, MD, PhD
Centre Val d'Aurelle - Paul Lamarque