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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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
Conditions
Interventions
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
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