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.

Inclusion Criteria:

- Histological confirmation of adenocarcinoma of the prostate, >= Gleason 6, clinical
stage T1a-T2c and planned for radical prostatectomy

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

- Platelet count >= 50,000/mm^3

- Hemoglobin > 9.0 g/dL

- Creatinine =< 2.0 mg/dL

- Provide informed written consent

- Willing to return to enrolling institution for follow-up (during the Active Monitoring
Phase of the study); Note: during the Active Monitoring Phase of a study (i.e., active
treatment and observation), participants must be willing to return to the consenting
institution for follow-up

- Patients must also provide written consent for biospecimens collection on
Institutional Review Board (IRB) 08-000980

Exclusion Criteria:

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm

- History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

- History of a venous thromboembolic event, cerebrovascular accident (CVA), hepatic
impairment, or heart failure