Trial Information

Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent

OBJECTIVES: I. Determine the ability of flutamide to reduce the incidence of prostate cancer
in patients with high grade prostatic intraepithelial neoplasia. II. Determine the effect of
this regimen on a series of endpoint biomarkers in these patients. III. Assess the quality
of life of these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to age (under 65 versus 65 and over), PSA (0-2.5 versus 2.6-4.0
versus 4.1-10 versus greater than 10 ng/mL), PIN (on one biopsy versus on two biopsies), and
family history (prostate cancer in brother, father, or uncle versus no prostate cancer in
these relatives). Patients are randomized to one of two treatment arms. Arm I: Patients
receive oral flutamide once daily. Arm II: Patients receive an oral placebo once daily.
Treatment continues for 1 year in the absence of disease progression or unacceptable
toxicity. Quality of life is assessed before study, at 1, 6, and 12 months, and then
annually therafter. Patients are followed annually for up to 10 years.

PROJECTED ACCRUAL: A total of 212 patients (106 per arm) will be accrued for this study in
approximately 2 years.