Wake Forest University Baptist Medical Center has begun enrolling healthy men age 55 and older in the largest-ever prostate cancer prevention study, to determine if selenium and vitamin E prevent prostate cancer.
Launched by the National Cancer Institute (NCI) and a network of researchers known as the Southwest Oncology Group, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) will determine if these two dietary supplements can protect against prostate cancer, the second most common form of cancer in men.
SELECT is the first study to look specifically at the effects of vitamin E and selenium, both separately and together, in preventing prostate cancer. The study, involving 400 sites in the United States, Puerto Rico and Canada, will include a total of 32,400 men and will take up to 12 years to complete. Study investigators hope to recruit all study participants during the first five years of the trial, so that each man can be followed for at least seven years.
"This is an extremely important study," said Electra Paskett, Ph.D., program director of Cancer Control Research at the Comprehensive Cancer Center of Wake Forest University. "Previous research with vitamin E and selenium - in studies focused on other types of cancer - suggested that these nutrients might prevent prostate cancer. SELECT is focused on prostate cancer and, when the study is finished, we will know for sure whether these supplements can prevent the disease," she said.
"It is crucial that men of all races and ethnic backgrounds participate in SELECT," said Paskett. "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 SELECT study at age 50, versus 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 unexpected byproducts of two other large cancer prevention trials.
In a 1996 study of selenium to prevent nonmelanoma skin cancer, 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, those who took vitamin E had 32 percent less prostate cancer. Neither beta carotene nor vitamin E was shown to prevent lung cancer.
Men in the SELECT study will visit their study site once every six months. Upon enrollment, they will be randomly assigned to one of four groups. One group will take 200 micrograms of selenium daily plus an inactive capsule, or placebo, that looks likes 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 may be able to participate in SELECT if they are age 55 or older (50 or older for African-American men); have never had prostate cancer and have not had any other cancer, except nonmelanoma skin cancer, in the last five years; and are generally in good health.
For more information on the SELECT study at Wake Forest University Baptist Medical Center, call Irma Richardson, study coordinator, at 336-716-7589 or 1-877-298-0110 option 4.
Media Contact: Jonnie Rohrer, (336) 716-6972, Mark Wright or Bob Conn, 336-7