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The Selenium and Vitamin E Cancer Prevention Trial, or SELECT is the largest-ever nationwide prevention study for prostate cancer undertaken by the National Cancer Institute (NCI). More than 32,000 men at over 400 sites in the United States, Puerto Rico, and Canada will be recruited. The University of Hawaii Minority-Based Clinical Oncology Program located at the Cancer Research Center of Hawaii is a one of the sites selected to conduct this study.
Rationale
Prostate cancer is a major public health problem with nearly 200,000 new cases of prostate cancer and more than 30,000 prostate cancer deaths each year in the United States. African-American men have the highest risk of developing the disease, but all men are at risk.
Primary prevention of prostate cancer through dietary supplementation is a promising strategy to reduce the morbidity and mortality of this disease. Selenium and vitamin E were chosen based on intriguing secondary analysis of data from two prospective, randomized cancer prevention trials. In a clinical trial conducted by Clark et al., prostate cancer incidence was reduced by two-thirds among men receiving daily selenium supplementation(1). In the Alpha-Tocopherol, Beta-Carotene (ATBC) Cancer Prevention Study carried out in Finland, there was a one-third reduction in prostate cancer incidence and a 40% reduction in prostate cancer mortality in men randomized to receive vitamin E (2). A confirmatory trial, SELECT, with prostate cancer incidence as one of the primary endpoints is needed to substantiate these findings.
Objectives
The primary objective of SELECT is to assess the effect of selenium and vitamin E on the incidence of prostate cancer diagnosed during routine clinical practice. Secondary objectives include assessing the impact of selenium and vitamin E on the incidence of lung and colon cancer and on cancer-specific survival and overall survival. Quality of life, evaluation of molecular and genetic markers of cancer risk, other biomarkers, and measures of nutrient intake will also be assessed.
Eligibility
SELECT will include healthy male participants, age 55 and older (age 50 and older for African-American men) who have had a non-suspicious DRE and a total PSA less than or equal to 4.0 ng/ml within 180 days of randomization. Additional eligibility criteria may be obtained by contacting the study site.
Participants will receive either 200 mcg of selenium, 400 mg of vitamin E, both, or placebos for up to 12 years. Blood samples and toenail clippings will be requested from all participants.
For more information in Hawaii, contact the Clinical Trials Unit, (808) 586-2979.
For information on study sites outside of Hawaii, call the National Cancer Institute's Cancer Information Service at 1-800-4- CANCER. In Canada, call the Canadian Cancer Society's Cancer Information Service at 1-888-939-3333.
Or visit http://www.crab.org/select on the Internet.