A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GTx
• Treatments: Toremifene

Criteria

• Must have confirmed high grade PIN on prostate biopsy within past 6 months.

• Must have a serum PSA <12 ng/ml.

• Can not have prostate cancer.

• Have significant ocular opacities.

• Can not take finasteride or other testosterone like supplement.