SELECT Prostate Cancer Trial Ends Recruitment

Goal Expected to be Reached Two Years Early

Recruitment ends this month for more than 400 institutions participating in the Selenium and Vitamin E Cancer Prevention Trial (SELECT), since the overall recruitment goal of 32,400 men will be met - two years early.

The recruitment process began in July 2001 and was expected to extend to 2006, says Karen Anderson, the study's recruitment and adherence coordinator with Cancer Research and Biostatistics (CRAB), the company collecting data for the trial. The study is administered by Southwest Oncology Group and sponsored by the National Cancer Institute.

It is very exciting that we are reaching our goal so early," Anderson says. "The research plan allowed for five years of recruitment. They thought there would be an initial surge of interest in the trial but that interest would wane, but it hasn't."

Study details

The study, which is being conducted at sites throughout the United States, Canada and Puerto Rico, was created to determine whether the mineral selenium and vitamin E prevent prostate cancer, the third-leading cancer killer in men.

Participants take one of the following combinations of pills:

• Two placebos
• Selenium and a placebo
• Vitamin E and a placebo
• Selenium and Vitamin E

Not knowing which pills they have been assigned, men in the study take the supplements and/or placebos daily for seven to 12 years. They return to their study site every six months for follow-up visits.

Trial results could be available in nine years, Anderson says. Results could be announced sooner, however, if the study's data safety and monitoring committee were to discover any significant findings that prove or disprove the theory that selenium or vitamin E can prevent prostate cancer.

Minority efforts

SELECT has succeeded in its efforts to recruit African-Americans, who are more likely to be diagnosed with prostate cancer and are twice as likely to die from the disease than men of any other racial or ethnic background.

African-American recruitment is currently at 15% of the total enrollees, Anderson says. The success of minority accrual is due to a widespread effort. Taking the lead has been SELECT's National Minority and Medically Underserved Subcommittee chaired by Elise D. Cook, M.D., principal investigator on the M. D. Anderson SELECT study and assistant professor in the Department of Clinical Cancer Prevention.

Using recruitment data from the trial's web-based database, the committee has been able to identify study sites with low African-American recruitment that could benefit from minority recruitment workshops. It also focused recruitment efforts in cities with high African-American populations.

"The beauty of the web-based program is that we can see how sites are doing," Cook says. "If sites are having trouble getting data submitted, we can send staff there to mentor them, and turn sites around."

The M. D. Anderson SELECT trial has an African-American recruitment rate of 27%, the 10th highest in the study, and was expected to surpass its overall recruitment goal of 350 by the end of the month.

"It is going extremely well," Cook says. "Interest has been high, and we are hoping for good results. What is so exciting about this trial is that on secondary analysis from other trials, these agents - selenium and vitamin E - showed a 30% to 50% reduction in incidence of prostate cancer. And if we can see the minimum benefit of 30% reduction in incidence of this cancer in the men on the SELECT study, this would provide significant public health benefit.

"If these supplements produce the same results in the general population, with an expected 200,000 new cases of prostate cancer annually, that could mean that 60,000 men would not have to hear the words, 'you have prostate cancer'."