Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00943956|
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : May 25, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: bicalutamide Drug: everolimus Drug: leuprolide acetate Radiation: external beam radiation therapy||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2009|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Everolimus + radiation
|Drug: bicalutamide Drug: everolimus Drug: leuprolide acetate Radiation: external beam radiation therapy|
- Acute and late toxicities [ Time Frame: 1 year ]
- Biochemical-free survival [ Time Frame: 1 year ]
- Metastasis-free survival [ Time Frame: 1 year ]
- Overall survival [ Time Frame: 1 year ]
- Pre-treatment molecular characteristics of the tumor and its correlation with outcomes [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|