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

GTx

Status and phase: Completed; Phase 2

Conditions: Prostatic Intraepithelial Neoplasia

Treatments: Drug: GTX-006 (Acapodene)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00028353

211

Details and patient eligibility

About

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.

Full 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).

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind