NCT00106691

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

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 Intraepithelial Neoplasia (PIN)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,589 (actual)
• Sponsor: GTx · Industry
• Sex: Male
• Age: 30 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Preneoplastic Conditions
• Prostatic Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	Toremifene 20 mg	The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).
DRUG	Placebo	The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Timeline

• Start date: 2005-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2005-03-30
• Last updated: 2023-06-12
• Results posted: 2023-06-12

Locations

138 sites across 3 countries: United States, Argentina, Canada