We propose to evaluate the chemoprevention of prostate cancer among men who are, by virtue of having been diagnosed with High Grade Prostatic Intraepithelial Neoplasia (HGPIN), at a greatly elevated prostate cancer risk. After a biopsy-based diagnosis of HGPIN, each subject will be re- biopsied to minimize the probability he has PC missed by the first biopsy. Subjects will then be randomized to either 200 mcg/day of selenium in the form of L-selenomethionine or to a matching placebo. After randomization, each subjective will be followed for three years. The primary endpoint of this study is PC. Secondary endpoints will include two established Surrogate Endpoint Biomarkers (SEBs): Ki-67 evaluation of cell proliferation and TUNEL evaluation of apoptosis. Each of these endpoints will be evaluated for reproducibility, predictive association with subsequent PC, and for response to selenium supplementation. In addition, we propose a developmental investigation of two potential SEBs that are based on machine vision histometry: erosion of the basal cells of prostatic ducts and histometric characteristics of chromatin patterns. These developmental SEBs will be investigated for reproducibility.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
6U01CA077178-07
Application #
6867508
Study Section
Special Emphasis Panel (ZCA1-OAA-5 (M1))
Project Start
1998-09-30
Project End
2004-07-31
Budget Start
2003-10-01
Budget End
2004-07-31
Support Year
7
Fiscal Year
2003
Total Cost
$821,563
Indirect Cost
Name
Cancer Therapy and Research Center
Department
Type
DUNS #
010550366
City
San Antonio
State
TX
Country
United States
Zip Code
78229