Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: bicalutamide; Drug: everolimus; Drug: leuprolide acetate; Radiation: external beam radiation therapy

• Registration Number: NCT00943956
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* To assess acute and late toxicities in patients with high-risk, locally advanced prostate cancer.

Secondary

* 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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	leuprolide acetate	Everolimus + radiation
Everolimus	external beam radiation therapy	Everolimus + radiation
Everolimus	bicalutamide	Everolimus + radiation
Everolimus	everolimus	Everolimus + radiation

Primary Outcome Measures

Name	Time	Method
Acute and late toxicities	1 year

Secondary Outcome Measures

Name	Time	Method
Biochemical-free survival	1 year
Overall survival	1 year
Metastasis-free survival	1 year
Pre-treatment molecular characteristics of the tumor and its correlation with outcomes	1 year

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France