Trial | NCT00028353  Report issue

Title

A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)

  • Phase

    Phase 2

  • Lead Sponsor

    GTx

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    toremifene ...

  • Study Participants

    500
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).
Study Started
Apr 30
2001
Study Completion
Jul 31
2003
Last Update
Nov 15
2013
Estimate

Drug GTX-006 (Acapodene)

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.
No Results Posted