By Tien-Shun Lee
Queens Hospital Center in Flushing began recruiting men last Monday for a study on the effect of selenium and vitamin E on the prevention of prostate cancer.
The study is part of a nationwide program, launched in July 2001 by the National Cancer Institute, which seeks to study 32,000 men in more than 400 sites across the United States, Canada and Puerto Rico.
“In prior studies, there has been evidence that vitamin E and selenium have prevented prostate cancer,” said Sharon Parness, the clinical trials coordinator at QHC. “Prior trials lay the groundwork for additional trials.”
According to the NCI, 1,000 men and women took selenium, a non-metallic trace element that is relatively abundant in seafood, meats and Brazil nuts, for a study in 1996 on the effect of the element on preventing skin cancer.
While the study found no benefit from selenium in preventing skin cancer, it did find that there were more than 60 percent fewer new cases of prostate cancer in those men taking selenium than in those not taking selenium.
Similarly, a 1998 study of 29,000 male smokers in Finland found that vitamin E had no benefit in preventing lung cancer, but did have an effect in preventing prostate cancer. The men in the study who took vitamin E had 32 percent fewer new cases of prostate cancer than those who took a placebo.
The new study, called the Selenium and Vitamin E Cancer Prevention Trial, or SELECT, is a four-armed trial that will give one group of men vitamin E and a placebo, another group selenium and a placebo, a third group a combination of selenium and vitamin E, and a fourth group two placebos.
In order to participate in the trial, men must be 55 or older if they are non-black, and 50 or older if they are black. The age requirement is lower for blacks because black men tend to get the disease at an earlier age. In addition, black men in the United States have the highest incidence of prostate cancer in the world.
In addition to fulfilling the age requirement, participants must have no prior history of prostate cancer and no history of any other cancer, except non-melanoma skin cancer, in the last five years.
Participants also must pass a digital rectal examination, where a doctor uses a gloved finger to feel the prostate gland through the rectal wall for bumps or abnormal areas, and a PSA test, which checks for the level of a protein produced by prostate gland cells in the blood.
“We expect to recruit 100 patients for the trial,” Parness said.
Depending on which study group they are placed in, participants will take 200 micrograms of selenium and/or 400 milligrams of vitamin E per day, if they are not in the placebo group. They will be asked to return to the study site every six months for 12 years to be evaluated, and to pick up more capsules.
If a participant develops prostate cancer during the course of study, he will be referred for treatment, and will be told to stop taking the study supplements.
In addition to the SELECT trial, QHC also is participating in a nationwide trial to determine the effect of two drugs, Tamoxifen and Raloxifene on the prevention of breast cancer. Close to 15,000 women are already participating in the three-year-old study, named the Study of Tamoxifen and Raloxifene, or STAR trial.
In order to participate in STAR, women must be post-menopausal, and must be considered at risk for breast cancer, based on family and personal history.
Tamoxifen is being studied for breast cancer prevention because it has been proven in previous trials to prevent breast cancer recurrence, Parness said. Raloxifene, which has been approved for treating osteoporosis, has been shown to reduce the incidence of breast cancer.
More women die from breast cancer in Queens than in the rest of the country, in part because Queens has a higher percentage of late-stage cancer detection than in the rest of the country, Parness said.
“There’s a large minority population in Queens,” Parness said. “Breast cancer, even though it’s more common in Caucasian women than in African-American women, more African-American women die from it than Caucasian women because it’s generally diagnosed at a later stage, because of the unavailability of services and lack of education.”
Recruitment for the STAR trial began in July. People interested in participating in either the STAR trial or SELECT can call 883-3751 for more information.
Reach reporter Tien-Shun Lee by e-mail at Timesledger@aol.com, or call 229-0300, ext. 155.
