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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00028353

Public ClinicalTrials.gov record NCT00028353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 3:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00028353
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
GTx
Industry
Enrollment
500 participants

Conditions and interventions

Eligibility (public fields only)

Age range
30 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2001 (Type not available)
Primary completion
Not listed
Completion
Jul 2003 (Type not available)
Last update posted
Nov 15, 2013

2001 – 2003

United States locations

U.S. sites
25
U.S. states
15
U.S. cities
24
Facility City State ZIP Site status
Private Practice Huntsville Alabama 35801 —
Arkansas Urology Associates Little Rock Arkansas 72211 —
South Florida Medical Research Aventura Florida 33180 —
UroSearch Leesburg Florida 34748 —
The Urology Center of Florida Inc. Ocala Florida 34474 —
UroSearch Ocala Florida 34474 —
Dr. Byron Hodge Orlando Florida 32806 —
H. Lee Moffitt Cancer Center Tampa Florida 33612-9497 —
Sandy Springs Urology, P.C. Atlanta Georgia 30328 —
North Idaho Urology Couer D'Alene Idaho 83814 —
Wishard Memorial Hospital Indianapolis Indiana 46202 —
Mid Atlantic Clinical Research Rockville Maryland 20850 —
Newton Wellesley Urology Newton Massachusetts 02162 —
Private Practice Las Vegas Nevada 89109 —
Medical & Clinical Research Associates Bay Shore New York 11706 —
Clinical Research of Westchester New Rochelle New York 10801 —
Columbia University New York New York 10032 —
Private Practice Staten Island New York 10305 —
Salem Research Group, Inc. Winston-Salem North Carolina 27103 —
Tri-State Urologic Services Cincinnati Ohio 45212 —
Urologic Surgery, P.C Bala-Cynwyd Pennsylvania 19004 —
Urology Associates of Lancaster Lancaster Pennsylvania 17604 —
Urology San Antonio Research San Antonio Texas 78229 —
Seattle Urological Associates Seattle Washington 98104 —
Madigan Army Medical Center Tacoma Washington 98431 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00028353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 15, 2013 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00028353 live on ClinicalTrials.gov.

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