NCT00028353

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: GTx · Industry
• Sex: Male
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

High grade PIN is the development of precancerous, abnormal tissue of the prostate gland that puts men at high risk of developing prostate cancer. This study will take one year of participation with clinic visits every three months. There will be two prostate biopsies during the study, at six and twelve months. If qualified to participate, you will be randomly assigned to one of four treatment groups. Three out of four groups are varying doses of the study medication and the other is the placebo group (like a sugar pill).

Conditions

• Prostatic Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	GTX-006 (Acapodene)

Timeline

• Start date: 2001-04-01
• Completion: 2003-07-01
• First posted: 2001-12-24
• Last updated: 2013-11-15

Locations

25 sites across 1 country: United States