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Sponsored by: |
GTx |
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Information provided by: | GTx |
ClinicalTrials.gov Identifier: | NCT00028353 |
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 |
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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).
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 211 |
Study First Received: | December 22, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00028353 |
Health Authority: | United States: Food and Drug Administration |
PIN High Grade Prostate Intraepithelial Neoplasia (PIN) |
Prostatic Intraepithelial Neoplasia Carcinoma in Situ Toremifene Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type |