Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer — UCDCC#215  

Prostate Cancer Clinical Trial

Official title: Phase II Trial of Bicalutamide and RAD001 in Patients With Hormone-Independent Prostatic Adenocarcinoma (HIPC) After the First-Line Androgen Deprivation Therapy

Status Completed

Clinical Trial Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they work compared with bicalutamide in treating patients with recurrent or metastatic prostate cancer.

Clinical Trial Description

OBJECTIVES:

• To compare the PSA response rate in patients with hormone-independent recurrent or metastatic adenocarcinoma of the prostate treated with bicalutamide and everolimus after first-line androgen deprivation therapy.

• To evaluate the time to treatment failure and overall survival of these patients.

• To assess the toxicity of bicalutamide and everolimus in these patients.

OUTLINE: Patients are stratified according to disease status (metastatic disease vs biochemical recurrence without measurable disease).

Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28-42 days and then every 3 months thereafter. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00814788
• Study type: Interventional
• Source: University of California, Davis
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Completion date: January 2016