Chemoprevention Trial of Selenium and Prostate Cancer
Abstract
The principal purpose of this trial is to assess the potential for the essential nutrient selenium (Se) to inhibit the progression of prostate cancer. The primary endpoints for this trial are the velocity at which the primary clinical marker of prostate cancer progresses, serum prostate-specific antigen (PSA) increases and the rate of development of metastases in the population undergoing prostatectomy. A key set of secondary end points consists of markers of tissue changes between initial diagnostic biopsy and radical prostatectomy. The scope of work is to randomize at least 110 participants to either a placebo or Se dosages of 200 %g, or 400 %g1day. Major findings have not yet occurred due to slow patient accrual. Recruitment was hindered in this trial by our decision to require frozen tissue specimens at both biopsy and radical prostatectomy. Based on the advice of our key consulting urologist, we have decided to work with both frozen tissue specimens and paraffin-embedded specimens; he and our collaborating investigators have informed us that the use of paraffin-embedded specimens will substantially increase our study accrual. We anticipate expedient results and significance as patient accrual accelerates.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1999
- Accession Number
- ADA383041
Entities
People
- Larry Clark
Organizations
- University of Arizona