SEATTLE — July 24, 2001 — Earlier today the National Cancer Institute announced the launch of the largest-ever prostate-cancer prevention study, a 12-year initiative that will involve 32,400 men in the United States, Canada and Puerto Rico. The study will seek to determine whether vitamin E and the trace element selenium can protect against prostate cancer, the most common form of malignancy, after skin cancer, in men.
The Fred Hutchinson Cancer Research Center houses the group that will oversee data analysis for this massive international effort, called the Selenium and Vitamin E Cancer Prevention Trial, or SELECT.
Local study participants will be recruited through Northwest Prostate Institute, Puget Sound Cancer Centers (two locations: Seattle and Edmonds), Swedish Cancer Institute, VA Puget Sound Health Care System and Virginia Mason Medical Center. Participants also will be enrolled at clinical sites in Spokane and Tacoma.
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.
A network of 400 research sites are recruiting participants for the study, all of which belong to a consortium of cancer-care centers and physicians known as the Southwest Oncology Group, or SWOG. The Hutchinson Center's Public Health Sciences Division houses the SWOG Statistical Center, which designed the statistical structure of the study and will lead the data management and analysis effort.
Overseeing the statistical center is the Hutchinson Center's John Crowley, Ph.D., a primary investigator for the $180 million, NCI-funded study. The Hutchinson Center received 20 percent of this research funding to conduct the study's data management and analysis.
Other key SELECT investigators from the Hutchinson Center's Public Health Sciences Division include lead statistician Phyllis Goodman, M.S.; nutritional epidemiologist Alan Kristal, Dr.P.H.; behavioral psychologist Carol Moinpour, Ph.D.; and molecular epidemiologist Janet L. Stanford, Ph.D.
Selenium is a trace element in grains, meat and fish. Vitamin E is found in vegetable oil, dark green, leafy vegetables and whole-grain cereal. Both are antioxidants that neutralize the effects of toxins known as "free radicals" that otherwise might damage the genetic material of cells and possibly lead to cancer.
The theory that selenium cuts prostate risk arose from an Arizona skin-cancer study, said Crowley, a member of the Hutchinson Center's Public Health Sciences Division and a professor of biostatistics at the University of Washington School of Public Health and Community Medicine.
"The trial showed that the selenium had no effect on the incidence of skin cancer. But churning through the data, they found an apparent reduction in the incidence of prostate cancer."
Similarly, a Finnish study to determine whether beta-carotene could reduce the incidence of lung cancer also included a vitamin E component. The trial showed, contrary to prevailing theory, that beta-carotene seemed to increase the risk of lung cancer while vitamin E appeared to be associated with a reduced number of prostate cancers.
Crowley said that while scientists don't know how either antioxidant might prevent prostate cancer specifically, some studies have shown that they inhibit or reduce tumor growth.
"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 medical oncologist Gary E. Goodman, M.D., principal investigator of the SELECT Study Center at Swedish Cancer Institute, the largest recruitment hub in Washington state.
"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," said Goodman, also an affiliate investigator in the Hutchinson Center's Public Health Sciences Division.
Men enrolled in the study will visit their local study site 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. The final group will be given two placebos.
Men who join SELECT need not change their diet, but if they wish to take a multivitamin, the study will provide, without charge, a specially formulated variety that contains neither selenium nor vitamin E.
Men may be able to participate in SELECT if they:
This year alone, 198,100 Americans will be diagnosed with prostate cancer and more than 31,500 men will die of it. In the state of Washington, 3,400 men will get prostate cancer and 500 men will die of it. Risk factors for the disease include being over age 55 or having a father or brother with prostate cancer. African-American males also have a higher incidence of the disease compared to men from other racial and ethnic groups.
"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 vs. 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."
For more information about the study or prostate cancer, call the NCI'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://www.cancer.gov/select or visit SWOG's Web site at http://www.swog.org and choose SELECT.
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Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the center's four scientific divisions collaborate to form a unique environment for conducting basic and applied science. Fred Hutchinson, in collaboration with its clinical and research partners, UW Medicine and Children's Hospital and Regional Medical Center, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest and is one of 40 nationwide. For more information, visit the center's website at www.fhcrc.org.