Double-blind, placebo-controlled trial of toremifene for the prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia

Abstract

1003 Background: Toremifene, a selective estrogen receptor modulator (SERM) marketed for the treatment of breast cancer, appears to have promise in preventing prostate cancer. A randomized, double-blind, placebo-controlled study was conducted to determine the incidence of prostate cancer in men with high-grade prostatic intraepithelial neoplasia (PIN) treated with toremifene. Methods: 514 patients with high-grade PIN and no evidence of prostate cancer at study entry were randomized to oral toremifene 20, 40, or 60 mg or placebo QD for 12 months. Patients were rebiopsied at 6 and 12 months (minimum 8 cores per biopsy). Initial and subsequent biopsies were evaluated by a central pathologist (Bostwick Laboratories) for diagnosis of high-grade PIN and prostate cancer. Cumulative risk reduction and 12-month point-estimate risk reduction were compared between each toremifene group and placebo with Mantel-Cox and Cochran-Mantel-Haenszel, respectively, stratified by study center. Results: The number of evaluable ...