Prostatic Intraepithelial Neoplasia
Conditions
Keywords
PIN, High Grade Prostate Intraepithelial Neoplasia (PIN)
Brief summary
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.
Detailed description
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).
Interventions
DRUGGTX-006 (Acapodene)
Sponsors
GTx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed