Good Early Response for New Prostate Cancer Prevention Study

Research sites around the country are reporting an enthusiastic early response to the announcement by the National Cancer Institute and the Southwest Oncology Group (SWOG) of their new prostate cancer Selenium and Vitamin E Cancer Prevention Trial, called SELECT. The study seeks 32,400 healthy men age 55 and older to test whether selenium or vitamin E, or both, can reduce the incidence of prostate cancer. It is estimated that the disease will be diagnosed in more than 198,000 American men this year and will kill 31,500, according to the American Cancer Society and the NCI. SELECT is being conducted at more than 400 sites in the United States, Canada, and Puerto Rico, including 38 Veterans Administration hospitals. Earlier studies have suggested that both Vitamin E and selenium can reduce prostate cancer risk, but a large confirmatory study is needed, researchers said in announcing SELECT. Two factors are getting credit for the positive early response from men interested in taking part in the study—The two nutritional supplements are well known and available over the counter, and media coverage of the July 24th announcement of the trial was extensive. The NCI's Cancer Information Service received 7,300 phone calls and Web site hits in the first 24 hours following the announcement. The Seattle center of the Cancer Information Service, which serves a six-state region, received more than 2,600 phone and computer inquiries in the first 24 hours. The Arizona Cancer Center in Tucson received more than 400 phone inquiries within the first three days of the announcement. Baylor University Medical Center in Dallas received about 250 inquiries in two days, and the University of Pittsburgh Cancer Institute received more than 100 calls in two days. About 75 calls were received at Rush Presbyterian St. Luke's Medical Center, one of 16 Chicago-area hospitals taking part in SELECT. “There has been a massive response from men, and we're very happy about that,” said Charles A. Coltman, Jr., MD, Chairman of SWOG and Director of the San Antonio Cancer Institute. SELECT is based on two earlier studies that were designed to test selenium and vitamin E as agents to prevent other kinds of cancer. Both showed promise for reducing the incidence of prostate cancer. The first study was reported in 1996 by Arizona Cancer Center epidemiologist Larry Clark, PhD—who died last year from prostate cancer at age 46. The study was designed to show whether selenium could prevent non-melanoma skin cancer. About 1,000 men and women took part in the trial, which failed to show a benefit with regard to skin cancer, but did show 60% fewer cases of prostate cancer in men randomized to selenium. The second study, reported in 1998, was designed to test vitamin E and beta carotene for their ability to prevent lung cancer in 29,000 Finnish men who smoked. Neither supplement prevented lung cancer, and, in fact, the men who smoked and took beta carotene were more likely to get lung cancer and die of it than those who did not take the supplement. But like the Arizona Cancer Center study, the Finnish study showed an unexpected result—a 32% reduction in prostate cancer in men randomized to vitamin E. “SELECT is the critical next step for pursuing the promising leads we saw for the prevention of prostate cancer,” said Leslie Ford, MD, Associate Director for Clinical Research in NCI's Division of Cancer Prevention. “The only way to determine the real value of these supplements for prostate cancer is to do a large clinical trial focused specifically on this disease.” 4 Treatment Groups Men who enroll in SELECT will be randomized to one of four treatment groups. One will take 200 micrograms of selenium daily plus a placebo that looks like vitamin E. A second group will take 400 milligrams of vitamin E daily and a placebo that looks like selenium. The third group will take both vitamin E and selenium, and the fourth will be given two placebos. Men will be asked to stay on their study drug for at least seven years and up to 12 years, or the full length of the study. Men who meet the eligibility criteria will be screened by digital rectal exam and PSA test, and those tests will be repeated annually for the duration of the study. Men with benign prostatic hyperplasia are eligible, but those with a history of prostate cancer or a diagnosis in the past five years of any other cancer, except for non-melanoma skin cancer, are excluded. Men who take vitamin E and selenium supplements can still enroll, but they have to agree to stop taking their supplements while they are in the study. While SELECT targets healthy men 55 and older, the minimum age is 50 for African-American men, who are more likely to develop prostate cancer than men in other racial and ethnic groups, and at a younger age. “We especially encourage them to consider joining this trial,” Dr. Ford said. To that end, the NCI and SWOG have partnered with the National Medical Association, the organization of African-American physicians, to help the study achieve its goal of 20 percent—about 6,500—African-American participants. Baylor University Medical Center's recruitment effort will include working with community centers and senior health centers that serve men of diverse racial and ethnic groups. Michael Goldstein, MD, a urologist and Chief of Clinical Research at the center, said outreach includes educating medical staff about the study and encouraging other physicians to refer their patients. “Our enrollment goal is 100 patients, but we hope to enroll many more than that,” Dr. Goldstein said. Gary E. Goodman, MD, SELECT principal investigator at Seattle's Swedish Cancer Institute and an investigator with the Hutchinson Center's Public Health Sciences Division, will oversee the largest group of participants: 5,000 men from Seattle and surrounding areas. “It is ambitious,” Dr. Goodman said, “but I'm quite hopeful that we can accomplish it.” Researchers agree that the relative safety of vitamin E and selenium will benefit recruitment efforts. But according to SELECT's Recruitment and Adherence Coordinator, challenges still need to be overcome. “We're asking men to take two supplements every day for the next seven to 12 years. That's difficult for a lot of people,” said Karen Anderson, who is with the Cancer Research and Biostatics Center in Seattle. The private company is under contract with Fred Hutchinson Cancer Research Center, which is overseeing data collection for the entire study. “And it's an aging population we're looking at,” Ms Anderson noted, “and they often have many other drugs to take, and may find it easy to say this is too much trouble.” Inquiries from Significant Others Ms. Anderson and others said a number of the inquiries about SELECT have been coming from spouses and significant others. Both participants and their partners will be offered a multivitamin that does not contain selenium or vitamin E, to take daily for the duration of the trial—a strategy designed to strengthen the support participants get at home for taking part in the study. In addition, Ms. Anderson said, wives and significant others can be made aware of opportunities to join clinical trials such as the Study of Tamoxifen and Raloxifene (STAR), which is comparing the two drugs for their safety and ability to prevent breast cancer. SELECT is the fourth largest cancer prevention trial funded by the NCI. The Breast Cancer Prevention Trial, involving more than 13,000 women, showed tamoxifen can reduce breast cancer incidence in healthy women by at least 50 percent. The STAR trial, which seeks to enroll 22,000 women, is ongoing. The Prostate Cancer Prevention Trial, which enrolled more than 18,000 men who were randomly assigned to the drug finasteride or a placebo, is nearing completion. SELECT is expected to cost about $180 million. Research sites will be paid $1,000 for each participant, to cover the costs of data collection and analysis, Dr. Ford said. Four pharmaceutical firms are donating the selenium, vitamin E, and placebos: Roche Vitamins Inc. of Parsippany, NJ; Sabinsa Corp. of Piscataway, NJ; Nutricia Manufacturing USA Inc. of Greenville, SC; and BioAdvantex Pharma Inc., of Mississauga, Ontario. Further information about SELECT is available from the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237), or the Canadian Cancer Society's Cancer Information Service at 1-888-939-3333; or from the NCI Web site at http://cancer.gov/select or the SWOG Web site at www.swog.org and click on SELECT.

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