Toremifene for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia: results of a double-blind, placebo controlled, phase IIB …

D Price, B Stein, P Sieber, R Tutrone, J Bailen… - The Journal of …, 2006 - Elsevier
PURPOSE: A randomized, double-blind, dose finding, placebo controlled, parallel group
clinical study was done to determine the incidence of prostate cancer in men with high grade
prostatic intraepithelial neoplasia treated with toremifene. MATERIALS AND METHODS: A
total of 514 patients with high grade prostatic intraepithelial neoplasia and no evidence of
prostate cancer on screening biopsy were randomized to 20, 40 or 60 mg toremifene, or
placebo daily for 12 months. Patients underwent re-biopsy at 6 and 12 months. RESULTS …