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.