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Spots Global Cancer Trial Database for A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)

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We do not endorse or review these studies in any way.

Trial Identification

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

Official Title:

Study ID: NCT00028353

Interventions

GTX-006 (Acapodene)

Study Description

Brief 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.

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).

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Private Practice, Huntsville, Alabama, United States

Arkansas Urology Associates, Little Rock, Arkansas, United States

South Florida Medical Research, Aventura, Florida, United States

UroSearch, Leesburg, Florida, United States

The Urology Center of Florida Inc., Ocala, Florida, United States

UroSearch, Ocala, Florida, United States

Dr. Byron Hodge, Orlando, Florida, United States

H. Lee Moffitt Cancer Center, Tampa, Florida, United States

Sandy Springs Urology, P.C., Atlanta, Georgia, United States

North Idaho Urology, Couer D'Alene, Idaho, United States

Wishard Memorial Hospital, Indianapolis, Indiana, United States

Mid Atlantic Clinical Research, Rockville, Maryland, United States

Newton Wellesley Urology, Newton, Massachusetts, United States

Private Practice, Las Vegas, Nevada, United States

Medical & Clinical Research Associates, Bay Shore, New York, United States

Clinical Research of Westchester, New Rochelle, New York, United States

Columbia University, New York, New York, United States

Private Practice, Staten Island, New York, United States

Salem Research Group, Inc., Winston-Salem, North Carolina, United States

Tri-State Urologic Services, Cincinnati, Ohio, United States

Urologic Surgery, P.C, Bala Cynwyd, Pennsylvania, United States

Urology Associates of Lancaster, Lancaster, Pennsylvania, United States

Urology San Antonio Research, San Antonio, Texas, United States

Seattle Urological Associates, Seattle, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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