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

November 13, 2013 updated by: GTx
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GTx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

December 22, 2001

First Submitted That Met QC Criteria

December 22, 2001

First Posted (Estimate)

December 24, 2001

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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