Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

PRIMARY OBJECTIVES: I. To collect and interrogate samples in patients with prostate cancer that were diagnosed with prostate cancer and are planned for radical prostatectomy at Mayo Clinic Arizona. SECONDARY OBJECTIVES: I. To describe the adverse event profile and tolerance of therapy for 60 days of treatment prior to surgery. II. To assess change in stage and/or grade of cancer and prostate specific antigen (PSA) response to neoadjuvant treatment in patients with hormone sensitive prostate cancer. TERTIARY OBJECTIVES: I. To evaluate specific pathways and changes when comparing biopsy specimens to prostatectomy. II. To describe the quality of life of patients receiving hormonal therapy prior to radical prostatectomy. OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 4 arms. ARM A: Patients receive low dose raloxifene hydrochloride orally (PO) daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. ARM C: Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. ARM D: Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.