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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
50 mg oral tablet daily
10 mg oral capsule daily
University of California Davis Cancer Center
Sacramento, California, United States
PSA Response Rate
The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.
Time frame: Up to 2 years
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: Up to 2 years
Overall Survival
Overall survival was estimated using the Kaplan-Meier method.
Time frame: Up to 3 years
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