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

Tracking Information
First Received Date ^ICMJE	December 22, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00028353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)
Official Title ^ICMJE
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).
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostatic Intraepithelial Neoplasia
Intervention ^ICMJE	Drug: GTX-006 (Acapodene)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	500
Completion Date	July 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00028353
Responsible Party
Study ID Numbers ^ICMJE	211
Study Sponsor ^ICMJE	GTx
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	GTx
Verification Date	September 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP