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| Sponsor: | GTx |
|---|---|
| Information provided by: | GTx |
| ClinicalTrials.gov Identifier: | NCT00028353 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Intraepithelial Neoplasia |
Drug: GTX-006 (Acapodene) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | July 2003 |
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| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Private Practice | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arkansas | |
| Arkansas Urology Associates | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, Florida | |
| UroSearch | |
| Ocala, Florida, United States, 34474 | |
| The Urology Center of Florida Inc. | |
| Ocala, Florida, United States, 34474 | |
| Dr. Byron Hodge | |
| Orlando, Florida, United States, 32806 | |
| South Florida Medical Research | |
| Aventura, Florida, United States, 33180 | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612-9497 | |
| UroSearch | |
| Leesburg, Florida, United States, 34748 | |
| United States, Georgia | |
| Sandy Springs Urology, P.C. | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Idaho | |
| North Idaho Urology | |
| Couer D'Alene, Idaho, United States, 83814 | |
| United States, Indiana | |
| Wishard Memorial Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Mid Atlantic Clinical Research | |
| Rockville, Maryland, United States, 20850 | |
| United States, Massachusetts | |
| Newton Wellesley Urology | |
| Newton, Massachusetts, United States, 02162 | |
| United States, Nevada | |
| Private Practice | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New York | |
| Clinical Research of Westchester | |
| New Rochelle, New York, United States, 10801 | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| Private Practice | |
| Staten Island, New York, United States, 10305 | |
| Medical & Clinical Research Associates | |
| Bay Shore, New York, United States, 11706 | |
| United States, North Carolina | |
| Salem Research Group, Inc. | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Tri-State Urologic Services | |
| Cincinnati, Ohio, United States, 45212 | |
| United States, Pennsylvania | |
| Urologic Surgery, P.C | |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| Urology Associates of Lancaster | |
| Lancaster, Pennsylvania, United States, 17604 | |
| United States, Texas | |
| Urology San Antonio Research | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
| Seattle Urological Associates | |
| Seattle, Washington, United States, 98104 | |
More Information
| Study ID Numbers: | 211 |
| Study First Received: | December 22, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00028353 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
PIN High Grade Prostate Intraepithelial Neoplasia (PIN) |
|
Prostatic Intraepithelial Neoplasia Neoplasms Neoplasms by Histologic Type |
Carcinoma in Situ Neoplasms, Glandular and Epithelial Carcinoma |
