Prostate Cancer Clinical Trial
Official title:
Pilot Trial to Evaluate the Safety and Efficacy of the Administration of Bicalutamide (Casodex TM) Per Day in Combination With Raloxifene (Evista TM) Per Day in Patients With Hormone Refractory Prostate Cancer
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.
OBJECTIVES:
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.
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