583 TOREMIFENE IMPROVES PSA PROGRESSION FREE SURVIVAL IN CASTRATE MEN WITH DETECTABLE BASELINE PSA LEVELS (2010)

You have accessJournal of UrologyProstate Cancer: Advanced I1 Apr 2010583 TOREMIFENE IMPROVES PSA PROGRESSION FREE SURVIVAL IN CASTRATE MEN WITH DETECTABLE BASELINE PSA LEVELS Daniel Lin, Michael Brawer, Mitchell Steiner, Ronald Morton, Gary Barnette, Matthew Smith, and Evan Yu Daniel LinDaniel Lin Seattle, WA More articles by this author , Michael BrawerMichael Brawer Memphis, TN More articles by this author , Mitchell SteinerMitchell Steiner Memphis, TN More articles by this author , Ronald MortonRonald Morton Memphis, TN More articles by this author , Gary BarnetteGary Barnette Memphis, TN More articles by this author , Matthew SmithMatthew Smith Boston, MA More articles by this author , and Evan YuEvan Yu Seattle, WA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.842AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We conducted a double blind, randomized, placebo controlled trial to determine if toremifene 80 mg could prevent fractures in men on androgen deprivation therapy (ADT). We also assessed the effect of toremifene on PSA progression free survival in a subset of men at the highest risk for progression. METHODS 1,284 men were randomized at 144 sites in the US and Mexico to placebo or toremifene 80 mg oral once daily for 2 years. All subjects had histologic documentation of prostate cancer, were on ADT for ¡Ý6 months, had a serum PSA ¡Ü4 ng/mL, Zubrod PS ¡Ü1 and were either >70 years of age or were at or below WHO thresholds for spine or hip (BMD). The modified intent to treat population included 913 subjects who received at least one dose of study drug and had at least one on-study radiograph. To evaluate the population at greatest risk for progression, only subjects with a detectable PSA ¡Ý0.1 ng/mL (low end sensitivity) at the time of randomization were analyzed for PSA progression free survival. PSA progression was defined by a rise in PSA level of ¡Ý25% increase over baseline and to >2 ng/mL. RESULTS Three hundred seventy two (372) subjects were eligible for this analysis (174 toremifene and 198 placebo). After 2 years of treatment, 47 of 174 (27.0%) developed PSA progression in the toremifene arm and 74 of 198 (37.4%) developed PSA progression in the placebo arm (p=0.049, log rank test). Among the 372 patients, there were no significant differences between the two arms in regards to age (p=0.96), race (p=0.23), years on ADT at baseline (p=0.44), baseline serum testosterone levels (p=0.45), and serum PSA level at baseline (p=0.22). CONCLUSIONS In addition to a demonstrated fracture benefit, toremifene may also offer antitumor activity for men receiving ADT for prostate cancer and who have a detectable PSA at baseline, as measured by 2-year PSA progression-free survival. Additional studies in a population of men with higher risk of prostate cancer progression should be considered. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e228-e229 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Lin Seattle, WA More articles by this author Michael Brawer Memphis, TN More articles by this author Mitchell Steiner Memphis, TN More articles by this author Ronald Morton Memphis, TN More articles by this author Gary Barnette Memphis, TN More articles by this author Matthew Smith Boston, MA More articles by this author Evan Yu Seattle, WA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...