SELECT Clinical Trial Thompson Cancer Survival Center at Methodist (TCSC-M) of Oak Ridge, through its association with Thompson Cancer Survival Center (TCSC) of Knoxville, TN., is enrolling men in the largest-ever prostate cancer prevention trial: the Selenium and Vitamin E Cancer Prevention Trial, or SELECT. The study's goal is to determine whether the two dietary supplements can protect against prostate cancer, the most common form of cancer in men after skin cancer. Healthy men age 55 and older are needed for the study, which was launched by the National Cancer Institute (NCI) in 2001. More than 400 sites in the United States, Puerto Rico, and Canada are recruiting participants for SELECT, which will take up to 12 years to complete. The study will include a total of 32,400 men. "SELECT is the first study designed to look directly at the effects of vitamin E and selenium, both separately and together, in preventing prostate cancer," said Spence McCachren, M.D., principal investigator from TCSC. John Foust, M.D., at TCSC-M also is participating in the study. "Previous research involving vitamin E and selenium suggested that these nutrients might prevent prostate cancer, but we don't know for sure. When SELECT is finished we will know whether these supplements can prevent prostate cancer," Dr. McCachren added. In 2001, prostate cancer was diagnosed in about nearly 200,000 American men and more than 31,500 others were expected to die of the disease. Risk factors include being over age 55, being African-American, or having a father or brother with prostate cancer. "It is crucial that men of all races and ethnic backgrounds participate in SELECT," said Leslie Ford, M.D., associate director for clinical research in NCI's Division of Cancer Prevention. "And since African-American men have the highest incidence of prostate cancer in the world, we especially encourage them to consider joining this trial." The disease also strikes black men at a younger age, so they will be eligible to enroll in the study at age 50, versus age 55 for other racial and ethnic groups. There is no upper age limit for participation in SELECT. The study is important for the men who join, not only because they might prevent prostate cancer in themselves, but also because researchers could make discoveries that might benefit future generations. Selenium and vitamin E, both naturally occurring nutrients, are antioxidants. They are capable of neutralizing toxins known as "free radicals" that might otherwise damage the genetic material of cells and possibly lead to cancer. These nutrients were chosen for study because of the results of two other large cancer prevention trials. In a study of selenium to prevent one type of non-melanoma skin cancer in 1,000 men and women, reported in 1996 *, investigators found that while the supplement did not reduce skin cancer, it did decrease the incidence of prostate cancer in men by more than 60 percent. Another trial, published in 1998 **, in which beta-carotene and vitamin E were tested to prevent lung cancer in 29,000 Finnish men who smoked, those who took vitamin E had 32 percent less prostate cancer. Neither beta-carotene nor vitamin E prevented lung cancer. In fact, the men who smoked and took beta-carotene were more apt to get lung cancer and die from it than men who didn't take this supplement. "SELECT is the critical next step for pursuing the promising leads we saw for the prevention of prostate cancer," said Ford, who is responsible for all aspects of NCI's involvement in SELECT. "The only way to determine the real value of these supplements for prostate cancer is to do a large clinical trial focused specifically on this disease." Study investigators hope to recruit all the study participants during the first five years of the trial, so that each man can be followed for at least seven years. Men in the study from East Tennessee visit the study site of their choice once every six months. Upon enrollment, they are assigned by chance to one of four groups. One group will take 200 micrograms of selenium daily plus an inactive capsule, or placebo, that looks like vitamin E. Another group will take 400 milligrams of vitamin E daily along with a placebo that looks like selenium. A third group will take both selenium and vitamin E. And a final group will be given two placebos. Men who join SELECT will not need to change their diet in any way. However, they must stop taking any supplements they buy themselves that contain selenium or vitamin E. Participants who wish to take a multivitamin will receive, without charge, a specially formulated one that does not contain selenium or vitamin E. To participate, men must: Be age 55 or older; age 50 or older for African-Americans Have never had prostate cancer or any other cancer, except non-melanoma skin cancer, in the last five years Be generally in good health To join the study, call Brenda Morris, R.N., at Thompson Cancer Survival Center at Methodist (865-481-1664) or Jamie Breeden, R.N., at Thompson Cancer Survival Center (865-541-2421). For more information about SELECT or prostate cancer, contact one of the following: In the United States, including Puerto Rico, call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for English and Spanish versions. People with TTY equipment should call 1-800-332-8615. In Canada, call the Canadian Cancer Society's Cancer Information Service at 1-888-939-333 for English and French versions. Visit NCI's SELECT web site at http://www.cancer.gov. *Clark LC, Combs GF Jr., Turnbull BW, et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group. JAMA 276: 1957-1963, 1996. ( back) **Heinonen OP, Albanes D, Huttunen JK, et al. Prostate cancer and supplementation with alpha-tocopherol and beta-carotene: incidence and mortality in a controlled trial. J Natl Cancer Institute 90: 440-6, 1998. ( back)

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