Chemoprevention Trial of Selenium and Prostate Cancer
Annual rept. 1 Oct 1998-30 Sep 1999
ARIZONA UNIV TUCSON
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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.
- Medicine and Medical Research