Largest-Ever Prostate Cancer Prevention Trial Enters Second Year Of Recruitment
The largest-ever clinical trial focusing on prostate cancer prevention has entered its second year, examining the effectiveness of selenium and vitamin E as potential tools in the prevention of the second leading cause of cancer deaths among men.
Date: 9/6/2002
BIDMC Contact: Jerry Berger
Phone: 617-667-7308
BOSTON –The largest-ever clinical trial focusing on prostate cancer prevention has entered its second year, examining the effectiveness of selenium and vitamin E as potential tools in the prevention of the second leading cause of cancer deaths among men.
SELECT, the Selenium and Vitamin E Cancer Prevention Trial, will ultimately enroll 32,400 men at 435 centers across the United States, Canada and Puerto Rico. Researchers hope to enroll all the participants for this trial during the next four years. Men in the study will be followed for seven to 12 years, depending on when they enroll in the trial.
Launched in July 2001, SELECT is sponsored by the National Cancer Institute (NCI) and seeks to enroll healthy men aged 55 or older (50 or older for African-Americans). This trial is attempting to determine if either selenium or vitamin E can protect against prostate cancer, which ranks only behind skin cancer as a cause of death among men.
“In the 12 months since the launch, Beth Israel Deaconess Medical Center (BIDMC) has worked tirelessly to educate men and their families in Massachusetts about prostate cancer and the potential benefits of participating in this study,” said Dr. Glenn Bubley, the principal investigator. “In this next year, we will continue to talk to men about their prostate cancer risk and ask them if they are willing to help us learn whether the effects of selenium and vitamin E, both separately and together, can prevent the disease.”
Previous research involving selenium and vitamin E for other cancers suggested these nutrients might reduce the risk of prostate cancer by 60 to 30 percent, respectively. Selenium and vitamin E, both naturally occurring nutrients, are anti-oxidants. They are capable of neutralizing toxins known as “free radicals” that might otherwise damage the genetic material of cells and possibly lead to cancer.
During 2002, prostate cancer will be diagnosed in about 189,000 Americans and more than 30,200 men are expected to die of the disease. In 2002,Massachusetts, 4,600 men will get prostate cancer and 700 men will die of it. Risk factors include being over age 55, being African-American, or having a father or brother with prostate cancer.
Of the 13,951 men currently enrolled in SELECT, 1,619 (11 percent) are African-American. Because African-American men are at a greater risk of developing prostate cancer, they are eligible to join SELECT beginning at age 50 (compared with age 55 for other racial and ethnic groups.
“We are obviously quite pleased with the enormous success in the first year,” said Leslie G. Ford, M.D., associate director for clinical research in NCI’s Division of Cancer Prevention who is overseeing SELECT for NCI. “In this next year, we will place increased emphasis on reaching out to African-American men and asking them to consider enrolling in SELECT.
“It is crucial that men of all races and ethnic backgrounds participate in SELECT,” Ford added. Black men in the United States have the highest rate of prostate cancer in the world.
“The men who have joined SELECT thus far have expressed a satisfaction in having the opportunity both to possibly prevent prostate cancer for themselves and to help their sons and grandsons look forward to a future free from the disease,” said Charles A. Coltman, Jr., M.D., chairman of the Southwest Oncology Group (SWOG) and director of the San Antonio Cancer Institute in Texas. SWOG is the research network that is coordinating the study for NCI.
Men in the study from eastern New England will visit BIDMC 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, a specially formulated, free multivitamin will be provided through SELECT 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 African-American men; have never had prostate cancer or any other cancer, except non-melanoma skin cancer, in the last five years; are generally in good health.
For more information about the trial, call (617) 667-9187. For more information about the study or prostate cancer 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. Or visit NCI’s Web site at http://cancer.gov/select or visit SWOG’s Web site at http://swog.org and choose SELECT.
Beth Israel Deaconess Medical Center is a major patient care, research and teaching affiliate of Harvard Medical School and a founding member of CareGroup Healthcare System. Beth Israel Deaconess is the third largest recipient of National Institutes of Health (NIH) research funding among independent U.S. teaching hospitals.
