Healthy South Florida 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 Cancer Institute at Good Samaritan Medical Center, which is part of a network of research sites known as the Southwest Oncology Group (SWOG). The Selenium and Vitamin E Cancer Prevention Trial, or SELECT, seeks to determine if these two dietary supplements can protect against prostate cancer, the most common form of cancer second to skin cancer, in American 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 Principal Investigator Dr. Neal Rothschild, M.D., of Good Samaritan 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 is estimated to be diagnosed in about 198,100 Americans and more than 31,500 men are expected to die of the disease. In Florida, 15,000 men are estimated to get prostate cancer and 2,400 men are estimated to die of it. Risk factors for the disease include being over age 55, being black, 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, instead of age 55 for other racial and ethnic groups.
There is no upper age limit for participation in SELECT.
"We are looking for quite a few good men to join SELECT," said Charles A. Coltman, Jr., M.D., chairman of SWOG and director of the San Antonio Cancer Institute in San Antonio, Texas. "This study is important for the men who join, not only because they might prevent prostate cancer for themselves, but also because what we learn has the potential to benefit future generations of men."
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.
Men in the study from Palm Beach County and the Treasure Coast will visit Good Samaritan 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, SWOG will provide, without charge, a specially formulated one that does not contain selenium or vitamin E.
Men may be able to participate in SELECT if they:
- are age 55 or older; age 50 or older for black men
- have never had prostate cancer and have not had any other cancer, except nonmelanoma skin cancer, in the last five years
- are generally in good health
Men interested in joining the study can call Dr. Neal Rothschild at (561) 671-7003.
For more information about the study:
- 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 information in English or Spanish. The number for callers with TTY equipment is 1-800-332-8615.
- In Canada, call the Canadian Cancer Society's Cancer Information Service at 1-888-939-3333 for information in English or French.
- Visit NCI's Web site at http://cancer.gov/select or visit SWOG's Web site at http://swog.org and choose SELECT