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NATIONAL INSTITUTES OF HEALTH
National Cancer Institute
SELECT Selenium and Vitamin E Cancer Prevention Trial:
SELECT Men Fighting to Prevent Prostate Cancer

WHAT is SELECT?
The Selenium and Vitamin E Cancer Prevention Trial is a very important research study taking place in the United States, Puerto Rico, and Canada. SELECT is trying to find out if taking selenium and/or vitamin E supplements can prevent prostate cancer. We already have some evidence that selenium and vitamin E may be able to prevent prostate cancer, but we don't know for sure.

SELECT is sponsored by the U.S. National Cancer Institute, a government agency. The study is coordinated by a group of researchers known as the Southwest Oncology Group. More than 32,000 men will take part in SELECT.

WHAT ARE MY CHANCES OF GETTING PROSTATE CANCER?
Prostate cancer is the most common type of cancer, after skin cancer, among men in the United States and Canada

Men of all ages, races, and ethnic groups can get prostate cancer. You are at higher risk if:

• you are age 55 or older.
• you are African-American.
• you have a father or brother with prostate cancer.

Our bodies need selenium and vitamin E We get selenium in our water and food, especially in seafood, meats, and Brazil nuts. We get vitamin E in a wide range of foods, especially vegetables, vegetable oils, nuts, and egg yolks. Selenium and vitamin E are anti-oxidants. It is believed that they help control the cell damage that can lead to cancer.

Two studies that looked at preventing other cancers suggested that selenium and vitamin E might prevent prostate cancer. In a study in the United States, men who took selenium were less likely to get prostate cancer. In a study in Finland, men who took vitamin E were less likely to get prostate cancer. But neither of these studies focused directly on prostate cancer.

SELECT is the first study to look directly at the effect of selenium and/or vitamin E on the risk of prostate cancer. This study is being done to find out if selenium and/or vitamin E can really prevent prostate cancer.

The amount of selenium and vitamin E used in SELECT is 200 micrograms (µg) of selenium and 400 International Units (TU) of vitamin E per day. Previous studies have shown that these amounts are safe.

WHO CAN PARTICIPATE IN SELECT?
You may be able to participate in SELECT if:

• you are a man age 55 or older, or an African-American man age 50 or older. This age difference is because prostate cancer appears at younger ages in African-American men than in men of other ethnic groups.
• you have never had prostate cancer.
• you have not had any other cancer for the last five years (except skin cancer).
• you are in generally good health.

WHAT WILL HAPPEN IF I PARTICIPATE IN SELECT?
If you decide to participate in our study, you will read and sign a consent form that explains SELECT in more detail. You will also be asked to complete other study forms

You will then be assigned by chance to take selenium, vitamin E, both, or inactive capsules that look like selenium or vitamin E. These inactive capsules are called placebos. They do not contain selenium or vitamin E. Neither you nor the researchers will know which of the capsules you are taking. All capsules are provided free of charge.

We will give you two bottles of capsules. One will contain selenium or a placebo that looks like selenium. The other will contain vitamin E or a placebo that looks like vitamin E. You should take one capsule from each bottle every day. You don't need to change your diet.

We will offer you and your significant other a free multivitamin that does not have selenium or vitamin E. If you are already taking supplements that contain selenium or vitamin E, we will ask you to stop taking them.

You will need to visit your Study Site every six months to pick up new bottles of capsules and to discuss your progress on the study. During the first year, we will contact you twice by phone to see how you are doing.

We will ask you to stay on the study for 7 to 12 years, depending on when you join. It is important for you to plan to stick with the study until it ends. However, if you change your mind, you may leave the study at any time for any reason.

WHY MIGHT I WANT TO PARTICIPATE IN SELECT?
As a SELECT participant, you will be a partner in medical research and may reduce your chance of getting prostate cancer. You will also have a chance to help future generations, including your sons and grandsons, become free of prostate cancer. Please discuss this brochure with your doctor, family, and friends.

HOW CAN I JOIN SELECT?
More than 400 study sites in the United States, Puerto Rico, and Canada are enrolling men in SELECT. If you are interested in participating, or want to find out more about the study, please call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The number for callers with TTY equipment is 1-800-332-8615. If you live in Canada, please call the Canadian Cancer Society's Cancer Information Service at 1-888-939-3333.

Information about how to join the study is also available at the SELECT Web site. To reach the Web site, go to http://swog.org and click on the link titled "SELECT." You can also call your local SELECT Study Site for information on how to join.

NATIONAL CANCER INSTITUTE
NIH Publication No. 01-4978
June 2001

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