The bicalutamide Early Prostate Cancer Program: Demography

BACKGROUND: The optimal treatment for early prostate cancer has yet to be established. A well-tolerated hormonal therapy such as bicalutamide could be a useful treatment option in this setting, either as adjuvant or immediate therapy. A major collaborative clinical trials program was set up to investigate bicalutamide as a treatment option for local prostate cancer (localized or locally advanced disease). METHODS: The bicalutamide Early Prostate Cancer program comprises three randomized, double-blind, placebo-controlled trials of similar design that are being conducted in distinct geographical areas (North America; Australia, Europe, Israel, South Africa and Mexico; and Scandinavia). Men with T1b-4N0-1M0 (TNM 1997) prostate cancer have been randomized on a 1:1 basis to receive bicalutamide 150 mg daily or placebo. Recruitment to the program closed in July 1998, and follow-up is ongoing. Study endpoints: include time to clinical progression, overall survival and tolerability. RESULTS: 8113 men aged 38 to 93 years (mean 66.9) were randomized over a 3-year period. 67.4% of the enrolled patients had localized disease (T1-2) and 66.4% had a Gleason score less than or equal to6 at study entry, while the majority of patients had node-negative (NO) disease; only 3.1% in two of the studies and none in the third study had confirmed N+ disease. Overall, 71.8% of the patients received therapy of primary curative intent within 16 weeks of randomization; the remainder received watchful waiting as their primary approach. Across the program, the two randomized groups are well balanced. CONCLUSION: This is the largest randomized clinical trial program to date in local prostate cancer and is expected to provide critical information on the role of bicalutamide as an addition to standard care for patients with local prostate cancer who have received a therapy of curative intent or are candidates for watchful waiting. (C) 2001 Elsevier Science Inc. All rights reserved.