Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028353
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2001-12-22
Brief Title:
A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia PIN
Sponsor:
GTx
Organization:
GTx
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 abnormalsuspicious 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None