Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide and leuprolide acetate may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with bicalutamide, leuprolide acetate, and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with bicalutamide and leuprolide acetate in treating patients with high-risk locally advanced prostate cancer undergoing radiation therapy.
Drug: leuprolide acetate
Radiation: external beam radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial to Evaluate Acute and Late Toxicities of Concurrent Treatment With Everolimus (RAD001) and Radio-Hormonotherapy in High-risk Prostate Cancer.(RHOMUS)|
- Acute and late toxicities [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Biochemical-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Metastasis-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Pre-treatment molecular characteristics of the tumor and its correlation with outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Everolimus + radiation
|Drug: bicalutamide Drug: everolimus Drug: leuprolide acetate Radiation: external beam radiation therapy|
- To assess acute and late toxicities in patients with high-risk, locally advanced prostate cancer.
- 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 with outcomes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943956
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||David Azria, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|