Stage II Prostate Adenocarcinoma Clinical Trial
Official title:
Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy
This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.
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.
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