30 Years
N/A
Male
Prostatic Intraepithelial Neoplasia
Trial Information
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).
Inclusion Criteria
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Authority:
United States: Food and Drug Administration
Study ID:
211
NCT ID:
NCT00028353
Start Date:
April 2001
Completion Date:
July 2003
Related Keywords:
- Prostatic Intraepithelial Neoplasia
- PIN
- High Grade Prostate Intraepithelial Neoplasia (PIN)
- Neoplasms
- Prostatic Intraepithelial Neoplasia
- Carcinoma in Situ
Name | Location |
|---|---|
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Mid Atlantic Clinical Research | Rockville, Maryland 20850 |
| Urology San Antonio Research | San Antonio, Texas 78229 |
| Seattle Urological Associates | Seattle, Washington 98104-1360 |
| Columbia University | New York, New York 10032-3784 |
| H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| 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 |
| Dr. Byron Hodge | Orlando, Florida 32806 |
| Sandy Springs Urology, P.C. | Atlanta, Georgia 30328 |
| North Idaho Urology | Couer D'Alene, Idaho 83814 |
| Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
| 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 |
| 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 |
