The principal purpose of this trial is to assess the potential for treatment with the essential trace element selenium (Se) to prevent prostate cancer (PCa). The rationale for this trial is based on the results of the Nutritional Prevention of Cancer Trial, a randomized, double-blind clinical intervention trial. The results of this trial show a 63 percent reduction in PCa incidence during the initial 10 years of follow up in the patients receiving 200 mug/d of Se compared to the placebo group1. The trial will randomize patients to either placebo or one of two Se dosages, 200 mug/d or 400 mug/d The primary endpoints for the trial are the incidence of PCa and the velocity of the primary serum marker of prostate cancer progression, prostate specific antigen (PSA). Safety endpoints for the trial include onset of early mild symptoms of Se toxicity as well as significant changes in liver and kidney enzyme levels. The trial will randomize at least 700 patients with persistently elevated PSA levels (greater than 4 ng/ml) and at least one negative biopsy for prostate cancer. The trial will follow patients for up to 57 months, (an average of 51 months) and have 80 percent power to detect a 50 percent decrease in the incidence of PCa with an alpha of 0.05. The treatment effect of 50 percent was selected because it is one half the treatment effect observed in the NPC trial after a two year treatment lag (RR=0.25). In addition to PCa incidence, prostate biopsies and surgical tissue will be analyzed to explore both biomarkers of prostate cancer progression and possible mechanisms by which Se supplementation affects PCa.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA077789-06
Application #
6918368
Study Section
Subcommittee G - Education (NCI)
Program Officer
Lieberman, Ronald
Project Start
1999-09-30
Project End
2005-07-31
Budget Start
2004-08-01
Budget End
2005-07-31
Support Year
6
Fiscal Year
2004
Total Cost
$750,000
Indirect Cost
Name
University of Arizona
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
806345617
City
Tucson
State
AZ
Country
United States
Zip Code
85721
Algotar, Amit M; Behnejad, Roxanna; Stratton, M Suzanne et al. (2014) Chronic use of NSAIDs and/or statins does not affect PSA or PSA velocity in men at high risk for prostate cancer. Cancer Epidemiol Biomarkers Prev 23:2196-8
Algotar, Amit Mohan; Hsu, Chui-Hseih; Singh, Parminder et al. (2013) Selenium supplementation has no effect on serum glucose levels in men at high risk of prostate cancer. J Diabetes 5:465-70
Algotar, Amit M; Stratton, M Suzanne; Ahmann, Frederick R et al. (2013) Phase 3 clinical trial investigating the effect of selenium supplementation in men at high-risk for prostate cancer. Prostate 73:328-35
Algotar, A M; Stratton, M S; Xu, M J et al. (2011) Dose-dependent effects of selenized yeast on total selenium levels in prostatic tissue of men with prostate cancer. Nutr Cancer 63:1-5
Han, Jun; Slate, Elizabeth H; Pena, Edsel A (2007) Parametric latent class joint model for a longitudinal biomarker and recurrent events. Stat Med 26:5285-302
Karunasinghe, Nishi; Ferguson, Lynnette R; Tuckey, John et al. (2006) Hemolysate thioredoxin reductase and glutathione peroxidase activities correlate with serum selenium in a group of New Zealand men at high prostate cancer risk. J Nutr 136:2232-5
Gonzalez, Juan R; Pena, Edsel A; Slate, Elizabeth H (2005) Modelling intervention effects after cancer relapses. Stat Med 24:3959-75
Karunasinghe, Nishi; Ryan, Jacqueline; Tuckey, John et al. (2004) DNA stability and serum selenium levels in a high-risk group for prostate cancer. Cancer Epidemiol Biomarkers Prev 13:391-7
Inoue, Lurdes Y T; Etzioni, Ruth; Slate, Elizabeth H et al. (2004) Combining longitudinal studies of PSA. Biostatistics 5:483-500
Meuillet, Emmanuelle; Stratton, Suzanne; Prasad Cherukuri, Durga et al. (2004) Chemoprevention of prostate cancer with selenium: an update on current clinical trials and preclinical findings. J Cell Biochem 91:443-58

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