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

NCT ID: NCT00028353

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2003-07-31

Brief Summary

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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

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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

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Prostatic Intraepithelial Neoplasia

Keywords

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PIN High Grade Prostate Intraepithelial Neoplasia (PIN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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GTX-006 (Acapodene)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GTx

INDUSTRY

Sponsor Role lead

Locations

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Private Practice

Huntsville, Alabama, United States

Site Status

Arkansas Urology Associates

Little Rock, Arkansas, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

UroSearch

Leesburg, Florida, United States

Site Status

The Urology Center of Florida Inc.

Ocala, Florida, United States

Site Status

UroSearch

Ocala, Florida, United States

Site Status

Dr. Byron Hodge

Orlando, Florida, United States

Site Status

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Sandy Springs Urology, P.C.

Atlanta, Georgia, United States

Site Status

North Idaho Urology

Couer D'Alene, Idaho, United States

Site Status

Wishard Memorial Hospital

Indianapolis, Indiana, United States

Site Status

Mid Atlantic Clinical Research

Rockville, Maryland, United States

Site Status

Newton Wellesley Urology

Newton, Massachusetts, United States

Site Status

Private Practice

Las Vegas, Nevada, United States

Site Status

Medical & Clinical Research Associates

Bay Shore, New York, United States

Site Status

Clinical Research of Westchester

New Rochelle, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Private Practice

Staten Island, New York, United States

Site Status

Salem Research Group, Inc.

Winston-Salem, North Carolina, United States

Site Status

Tri-State Urologic Services

Cincinnati, Ohio, United States

Site Status

Urologic Surgery, P.C

Bala-Cynwyd, Pennsylvania, United States

Site Status

Urology Associates of Lancaster

Lancaster, Pennsylvania, United States

Site Status

Urology San Antonio Research

San Antonio, Texas, United States

Site Status

Seattle Urological Associates

Seattle, Washington, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

Related Links

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http://www.gtxinc.com

Related Info

Other Identifiers

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211

Identifier Type: -

Identifier Source: org_study_id