MEDIA CONTACT: Mike Goodkind, (650) 725-5376, firstname.lastname@example.org, or M.A. Malone, (650) 723-6912,
COMMENT: Joseph Presti, MD, associate professor of urology, (650) 725-5544
PATIENT CONTACT: Interested volunteers may contact the Department of Urology at (650) 736-0697
Stanford physicians begin
enrolling men today in
largest-ever prostate cancer prevention trial
STANFORD, Calif. -- Healthy men age 55 and older are needed for the largest-ever prostate cancer prevention study, launched today by the National Cancer Institute (NCI) and the Department of Urology at Stanford University. The Selenium and Vitamin E Cancer Prevention Trial, or SELECT, seeks to learn if these two dietary supplements can protect against prostate cancer -- the most common form of cancer, after skin cancer, in men.
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 Joseph Presti, Jr., MD, associate professor of urology and director of the Genitouriary Oncology Program at Stanford University Medical Center. 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.
During this year alone, prostate cancer will be diagnosed in about 198,100 Americans and more than 31,500 men are expected to die of the disease, according to NCI figures. In California 17,500 men will get prostate cancer and 2,800 men will die as a result of the disease. Risk factors for the disease 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, MD, 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 African-American men at a younger age, so they will be eligible to enroll in the study at age 50, as opposed to age 55 for other racial and ethnic groups. There is no upper age limit for participation in SELECT.
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, Presti said.
In a study of selenium to prevent one type of nonmelanoma skin cancer in 1,000 men and women, 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, he said. The results were reported in 1996 in the Journal of the American Medical Association.
In another trial, in which beta carotene and vitamin E were tested to prevent lung cancer in 29,000 Finnish men who smoked, the incidence of prostate cancer was reduced by 32 percent. Neither beta carotene nor vitamin E prevented lung cancer, researchers reported in 1998 in the Journal of the National Cancer Institute. 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 of the NCI. 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 the Bay Area will visit the Department of Urology at Stanford University Medical Center once every six months. Upon enrollment, they will be 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, but they must stop taking any supplements they buy themselves that contain selenium or vitamin E. If participants wish to take a multivitamin, they will receive, without charge, a specially formulated one that does not contain selenium or vitamin E.
For more information about the study or prostate cancer:
Call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for information in English or Spanish. The number for callers with TTY equipment is 1-800-332-8615.
Visit NCI's Web site at http://cancer.gov/select or visit the Web site for the Southwest Oncology Group (which includes Stanford) at http://swog.org and choose SELECT.
Four pharmaceutical companies are providing selenium and vitamin E capsules and multivitamins for the study: Roche Vitamins Inc., Parsipanny, N.J.; Sabinsa Corporation, Piscataway, N.J.; Nutricia Manufacturing USA Inc., Greenville, S.C.; and BioAdvantex Pharma Inc., Mississauga, Ontario, Canada.
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This document was last modified:
Friday, 23-Jan-2009 18:26:19 PST