Memphis-based biotech GTx has initiated a pivotal phase III clinical
trial for Acapodene for the prevention of prostate cancer in high risk
men.
   
27 Jan 2005, 16:34 GMT - 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.

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc