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Completed

NCT Number: NCT00028353

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

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.

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Key information

Conditions

Prostatic Intraepithelial Neoplasia Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Private Practice, Huntsville, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

GTX-006 (Acapodene)

Drug

Sponsors and collaborators

Lead sponsor

GTx

Industry

Registry information

Important dates

Study start
2001
Study completion
2003
First posted
Dec 24, 2001
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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