Vitamin E and Selenium to be Tested as Prevention Agents

Several Omaha Health Care Providers to Participate

in Largest-Ever Prostate Cancer Prevention Trial

 

Healthy men age 55 and older are needed for the largest-ever prostate

cancer prevention study, launched today by the National Cancer Institute.

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, after skin cancer, in men.

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.

In Omaha, the University of Nebraska Medical Center and the Missouri

Valley Cancer Consortium will head the research study. For UNMC, Ralph

Hauke, M.D., an oncologist in the UNMC Eppley Cancer Center, will serve

as principal investigator. James Mailliard, M.D., a Creighton University

oncologist, will serve as principal investigator for the Missouri Valley

Cancer Consortium.

The UNMC portion of the study will allow men to participate at UNMC/Nebraska

Health System, Methodist Cancer Center, and Midwest Urology Associates.

The Missouri Valley Cancer Consortium portion of the study will allow men

to participate at Creighton Cancer Center, Alegent Health (Bergan Mercy

Medical Center and Immanuel Medical Center), and the Cancer Resource Center

in Lincoln. Each site is required to enroll at least 100 men over the first

five years of the study.

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, Dr. Hauke said. Previous research involving vitamin

E and selenium suggested that these nutrients might prevent prostate cancer,

but we dont know for sure. When SELECT is finished, we will know whether

these supplements can prevent prostate cancer.

Were delighted that Nebraska is part of this important national study,

Dr. Mailliard said. With multiple sites participating in Omaha and one

site in Lincoln, it should be very convenient for people to take part in

the study.

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 Nebraska, 1,200 men will get prostate cancer and 200 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 Leslie Ford, M.D., associate director for clinical research

in NCIs Division of Cancer Prevention. 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 the Southwest Oncology Group 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.

In a 1996 study of selenium to prevent one type of nonmelanoma skin

cancer in 1,000 men and women, 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, beta carotene and vitamin E were

tested to prevent lung cancer in 29,000 Finnish men who smoked. Neither

beta carotene nor vitamin E prevented lung cancer, but those who took vitamin

E had 32 percent less prostate 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 didnt take this supplement.

SELECT is the critical next step for pursuing the promising leads we

saw for the prevention of prostate cancer, said Dr. Ford, who is responsible

for all aspects of NCIs 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.

In Nebraska, men participating in the study will be required to visit

their participating health 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, 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 may contain

selenium or vitamin E. If participants wish to take a multivitamin, they

will receive, 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 nonmelanoma skin cancer, in the last five years;

·  are generally in good health.

For more information about the study or prostate cancer:

 · In the United States (including Puerto Rico), call the National

Cancer Institutes 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.

· Visit NCIs Web site at http://cancer.gov/select or visit Southwest

Oncology Groups Web site at http://swog.org and choose SELECT.

· Contact the NCI Press Office, (301) 496-6641, or the Southwest Oncology

Group, (210) 677-8808.

Four pharmaceutical companies are providing selenium and vitamin E capsules

and multivitamins for the study: Roche Vitamins Inc., Parsipanny, N.J.;

Sabinsa Corporation, Piscataway, N.J.; Nutricia Manufacturing USA Inc.,

Greenville, S.C.; and BioAdvantex Pharma Inc., Mississauga, Ontario, Canada.