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CHAO FAMILY COMPREHENSIVE CANCER CENTER AT UC IRVINE BEGINS ENROLLING MEN IN LARGEST-EVER PROSTATE CANCER PREVENTION TRIAL

Vitamin E and Selenium to Be Tested as Prevention Agents

Healthy men age 55 and older are needed for the largest-ever prostate cancer prevention study, launched today by the National Cancer Institute (NCI) and UC Irvine's Chao Family Comprehensive Cancer 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 learn if these two dietary supplements can protect against prostate cancer, the most common form of cancer in men after skin cancer.

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.

"This is a terrific study," said Dr. Anne R. Simoneau, a urologist at UCI Medical Center and principal investigator at this site. "There are strong data that vitamin E and selenium may prevent prostate cancer. We don't know for sure, as some of that information has come from trials where prostate cancer was not the main focus. This trial specifically addresses prostate cancer, and will address whether a combination of the two nutrients versus vitamin E or selenium alone works best in preventing prostate cancer."

During this year alone, prostate cancer will be diagnosed in about 198,100 Americans, and more than 31,500 men are expected to die of the disease. In California, 17,500 men will get prostate cancer, and 2,800 men will 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 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." 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 A. Coltman, Jr., 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.

"I know there is a tendency for people to think 'Why participate? I will just take the supplements,' or 'I won't participate because I may not get both supplements,'" said Dr. Simoneau. "But long-term trials like these are important to advance medical knowledge, in that the scientists' well-thought-out theories and careful study of the data don't always live up to their expectations when the trials are done. Thus, before having whole populations take supplements that involve effort and money, it is important we know for sure that they will be beneficial."

In a study of selenium to prevent one type of non-melanoma skin cancer in 1,000 men and women, reported in 1996, investigators found that while the supplement did not reduce skin cancer, it did decrease the incidence of prostate cancer in men by more than 60 percent.

In another trial, published in 1998, in which beta carotene and vitamin E were tested to prevent lung cancer in 29,000 Finnish men who smoked, those who took vitamin E had 32 percent less prostate cancer. Neither beta carotene nor vitamin E prevented lung cancer. In fact, the men who smoked and took beta carotene were more apt to get lung cancer and die from it than men who didn't take this supplement.

"SELECT is the critical next step for pursuing the promising leads we saw for the prevention of prostate cancer," said Ford, who is responsible for all aspects of NCI's involvement in SELECT. "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." 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.

Men in the study from Orange County and surrounding areas will visit UCI 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 non-melanoma skin cancer, in the last five years
are generally in good health

Men interested in joining the study can call toll-free the Chao Family Comprehensive Cancer Center, located at the UCI Medical Center campus, at 1-888-456-7067.

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.

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.

Four pharmaceutical companies are providing selenium and vitamin E capsules and multivitamins for the study: Roche Vitamins Inc., Parsipanny, N.J.; Sabinsa Corp., Piscataway, N.J.; Nutricia Manufacturing USA Inc., Greenville, S.C.; and BioAdvantex Pharma Inc., Mississauga, Ontario, Canada.

To find out more about the SELECT study at UCI Medical Center or to arrange an interview with Dr. Anne R. Simoneau, members of the media may call Andrew Porterfield at the University of California, Irvine at (949) 824-3969.
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Contact:
Andrew M. Porterfield
(949) 824-3969
amporter@uci.edu

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