The pivotal phase III trial is a double blind, placebo controlled, multicenter study. Patients with high grade prostatic intraepithelial neoplasia (PIN), the precancerous lesion in prostate cancer, will be randomized into two treatment groups: 20mg toremifene or placebo. The primary endpoint of the clinical trial is the incidence of prostate cancer.
GTx has received initial comments from the FDA on the preliminary review of the Special Protocol Assessment (SPA). As part of the SPA process, GTx plans to address these comments and resubmit the revised SPA.