Clinical Trial: Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic

Brief Summary: The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).

Detailed Summary: The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.
Sponsor: GTx

Current Primary Outcome: To assess the efficacy of toremifene in the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN) [ Time Frame: the primary outcomes measure was taken at 12, 24 and 36 months ]

Original Primary Outcome: To assess the efficacy of toremifene in the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN)

Current Secondary Outcome:

  • To assess the safety of toremifene in men with high grade PIN [ Time Frame: at each visit of the study ]
  • To assess the effect of toremifene on lipid levels [ Time Frame: baseline and month 36 ]
  • To assess the effect of toremifene on hormone levels [ Time Frame: baseline and month 36 ]
  • To assess the effect of toremifene on total and % free serum PSA (prostate specific antigen) levels [ Time Frame: baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months ]
  • To assess the effect of toremifene on the AUA (American Urological Association) symptom score [ Time Frame: baseline and 36 months ]
  • To assess the population pharmacokinetics of 20 mg toremifene in men [ Time Frame: baseline, 3 months, 6 months, 12 months, 18 months, 24 months, and 30 months ]


Original Secondary Outcome:

  • To assess the safety of toremifene in men with high grade PIN
  • To assess the effect of toremifene on lipid levels
  • To assess the effect of toremifene on hormone levels
  • To assess the effect of toremifene on total and % free serum PSA (prostate specific antigen) levels
  • To assess the effect of toremifene on the AUA (American Urological Association) symptom score
  • To assess the population pharmacokinetics of 20 mg toremifene in men


Information By: GTx

Dates:
Date Received: March 29, 2005
Date Started: January 2005
Date Completion:
Last Updated: January 31, 2013
Last Verified: January 2013