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.

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

Prostatic Intraepithelial Neoplasia

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).

GTX-006 (Acapodene)

Private Practice

Arkansas Urology Associates

South Florida Medical Research

UroSearch

The Urology Center of Florida Inc.

Dr. Byron Hodge

H. Lee Moffitt Cancer Center

Sandy Springs Urology, P.C.

North Idaho Urology

Wishard Memorial Hospital

Mid Atlantic Clinical Research

Newton Wellesley Urology

Medical & Clinical Research Associates

Clinical Research of Westchester

Columbia University

Salem Research Group, Inc.

Tri-State Urologic Services

Urologic Surgery, P.C

Urology Associates of Lancaster

Urology San Antonio Research

Seattle Urological Associates

Madigan Army Medical Center

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?