INCIDENCE OF BIOPSY-DETECTABLE PROSTATE CANCER IN THE REDUCTION BY DUTASTERIDE OF PROSTATE CANCER EVENTS (REDUCE) TRIAL: BLINDED 2-YEAR RESULTS

Abstract

INTRODUCTION AND OBJECTIVE: In the pre-planned analysis of the REDUCE study, the incidence of biopsy-detectable prostate cancer (PCa) is summarized using several methods, which yield different observed rates of PCa incidence. METHODS: REDUCE is an ongoing 4-year, international, randomized, double-blind, placebo-controlled, parallel-group study investigating the efficacy of dutasteride in reducing the risk of biopsydetectable prostate cancer. Eligible subjects were aged 5075 years, with a serum prostate specific antigen (PSA) 2.5-10 ng/mL (men aged 50-60 years) or 3.0-10 ng/mL (men aged >60 years) and a single, negative biopsy of 6-12 cores within 6 months prior to enrollment. After 2 and 4 years of treatment, transrectal ultrasound directed biopsies (10 cores) were performed. Blinded 2-year PCa results for all subjects are available and are summarized using crude, restricted crude, and modified crude rate methods. RESULTS: Definitions for each of the 3 methods for calculation of prostate cancer incidence are listed in the table below along with the actual calculated blinded 2-year results for subjects in the efficacy population (subjects with no PCa in baseline biopsy as assessed by the central pathology lab and who took at least one dose of study medication; n=8108). Blinded 2-year PCa rates in REDUCE