Conditions: Preneoplastic Conditions Prostatic Intraepithelial Neoplasia
Keywords: neoplasia chemoprevention cancer premalignant precancerous Chemoprophylaxis Intraepithelial Prostatic Neoplasia Neoplasia, Prostatic Intraepithelial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1589
Healthy volunteers: no

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 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.

Arms:
arm 1: The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days). arm 2: The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days

Interventions: intervention 1: Toremifene 20 mg intervention 2: Placebo
Intervention descriptions: intervention 1: The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days). intervention 2: The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Protocol document: