A Phase 2 interventional study of GTX-006 (Acapodene) in Prostatic Intraepithelial Neoplasia, sponsored by GTx. Completed at 25 sites in United States. Open to male participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2013-11-15.
Sponsored by GTx · Phase 2, Interventional, and Prevention
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.
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).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 500 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →GTx is the lead sponsor of 18 studies on the registry; none are open to participants now.
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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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