The Hutch will play a key role in 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 Selenium and Vitamin E Cancer Prevention Trial, or SELECT, 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 $180 million, National Cancer Institute-funded study - of which the Hutch will receive about $36 million - launched its recruitment phase last week.
The Hutch houses the group that will direct data analysis for the massive international effort. Dr. John Crowley, a researcher in the Public Health Sciences Division and a primary investigator for the study, will oversee the statistical coordinating effort.
Study investigators hope to recruit the study participants during the first five years of the trial so that each man can be followed for at least seven years.
If public response on opening day of the trial is an indication, meeting recruitment goals will not be a problem, said Nancy Zbaren, project director for the NCI's Cancer Information Service Pacific Region.
"We received 119 phone calls about the study in the early afternoon of the first day of recruitment," said Zbaren, whose Hutch office fields inquiries from individuals with questions about cancer from six states.
Local study participants will be recruited through the Northwest Prostate Institute, Puget Sound Cancer Centers, Swedish Cancer Institute, the Veterans Administration Puget Sound Health Care System and Virginia Mason Medical Center. Participants also will be enrolled at clinical sites in Edmonds, Spokane and Tacoma.
Network of 400 sites
A network of 400 research sites is recruiting participants, and all the sites belong to a consortium of cancer-care centers and physicians known as the Southwest Oncology Group, or SWOG. The Hutch's PHS division houses the SWOG Statistical Center, which designed the statistical structure of the study and will lead the data-management and analysis effort.
Other key SELECT investigators from PHS include lead statistician Phyllis Goodman, nutritional epidemiologist Dr. Alan Kristal, behavioral psychologist Dr. Carol Moinpour and molecular epidemiologist Dr. Janet Stanford.
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, also 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," he said. "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 seperately and together, in preventing prostate cancer," said medical oncologist Dr. Gary E. Goodman, 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," said Goodman, also an affiliate investigator in the Hutch PHS division.
"When SELECT is finished, we will know whether these supplements can prevent prostate cancer."
Men enrolled in the study will visit their local study sites 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 special variety that contains neither selenium nor vitamin E.
This year alone, 198,100 Americans will be diagnosed with prostate cancer, and more than 31,500 men will die of it.
In Washington state, 3,400 men will get prostate cancer and 500 men will die of it. Risk factors for the disease include being over age 55, being African American and having a father or brother with prostate cancer.
"It is crucial that men of all races and ethnic backgrounds participate in SELECT," said Dr. Leslie Ford, 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."
Blacks struck younger
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 Dr. Charles Coltman Jr., chairman of SWOG and director of the San Antonio Cancer Institute in San Antonio.
"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."
Crowley said he intends to be involved in the study both from the outside and inside.
"Having recently come of eligibility age, I will at be at Dr. Goodman's office first thing tomorrow morning, ready to sign up as a participant."
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.