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

Prostatic Intraepithelial Neoplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028353
• Other study ID #: 211
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2001
• Last updated: November 13, 2013
• Start date: April 2001
• Est. completion date: July 2003

Study information

• Verified date: November 2013
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Neoplasms
• Prostatic Intraepithelial Neoplasia

Intervention

Drug:
• GTX-006 (Acapodene)

Locations

Country	Name	City	State
United States	Sandy Springs Urology, P.C.	Atlanta	Georgia
United States	South Florida Medical Research	Aventura	Florida
United States	Urologic Surgery, P.C	Bala Cynwyd	Pennsylvania
United States	Medical & Clinical Research Associates	Bay Shore	New York
United States	Tri-State Urologic Services	Cincinnati	Ohio
United States	North Idaho Urology	Couer D'Alene	Idaho
United States	Private Practice	Huntsville	Alabama
United States	Wishard Memorial Hospital	Indianapolis	Indiana
United States	Urology Associates of Lancaster	Lancaster	Pennsylvania
United States	Private Practice	Las Vegas	Nevada
United States	UroSearch	Leesburg	Florida
United States	Arkansas Urology Associates	Little Rock	Arkansas
United States	Clinical Research of Westchester	New Rochelle	New York
United States	Columbia University	New York	New York
United States	Newton Wellesley Urology	Newton	Massachusetts
United States	The Urology Center of Florida Inc.	Ocala	Florida
United States	UroSearch	Ocala	Florida
United States	Dr. Byron Hodge	Orlando	Florida
United States	Mid Atlantic Clinical Research	Rockville	Maryland
United States	Urology San Antonio Research	San Antonio	Texas
United States	Seattle Urological Associates	Seattle	Washington
United States	Private Practice	Staten Island	New York
United States	Madigan Army Medical Center	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Salem Research Group, Inc.	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GTx

Country where clinical trial is conducted

United States, 

External Links

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