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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. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of prostate cancer.
PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating patients with metastatic or hormone-refractory prostate cancer.
I. To describe the 6-month progression-free survival rate, progression-free survival, and overall survival of patients receiving bicalutamide and raloxifene.
II. To describe the adverse event profile of combined treatment with bicalutamide and raloxifene (adverse events graded using the NCI CTCAE version 3.0).
III. To describe the quality of life of patients receiving bicalutamide and raloxifene.
OUTLINE: Patients receive oral bicalutamide and oral raloxifene on days 1-28. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
bicalutamide, raloxifene, quality-of-life assessment
Mayo Clinic Scottsdale-Phoenix
Published on BioPortfolio: 2014-08-27T03:16:34-0400
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