Trials try to Light the way to a Cure

Clinical trials are the only road to new standards of care in medicine. Without their scientific rigor, we would not be able to move forward to improve and hopefully someday, eliminate diseases.

There are many different types of clinical trials in cancer care. Here at the Bienes Cancer Center, we do mainly treatment, screening and prevention trials. I want to share an example of a National Cancer Institute funded prevention trial that we are participating in.

The Selenium and Vitamin E Cancer Prevention Trial (SELECT) is a clinical trial to see if one or both of these dietary supplements prevent prostate cancer. Over 35,000 men were enrolled across the USA, Canada and Puerto Rico. The study was based on findings from two separate studies in the past for cancer prevention. One looked at the use of vitamin C in multiple cancers and it indicated a reduced incidence of prostate cancer with this vitamin. The other study was testing the use of vitamin E in the reduction of many cancers and it also showed a reduced incidence of prostate cancer.    

The Bienes Cancer Research department has enrolled 121 men into this study since its inception in 2001. Each subject was randomized to combinations of Vitamin E, selenium or placebo. The men took their pills daily, came into the clinic for annual PSA tests and digital rectal examinations by our physicians. They also received phone calls every six months to gather more health related information. Recently, another component has been added to gather information about the incidental findings for any men in this trial who happened to have had a colonoscopy.

The pills were stopped in August 2008 because the data showed that taking vitamin E and selenium alone or together does not prevent prostate cancer. The data also showed that vitamin E may slightly increase the chance of getting prostate cancer. Selenium may be associated with a slightly increased risk of developing diabetes mellitus. However, these findings are not statistically significant and may be due to chance alone.

These men will remain on trial for another 2-3 years as we gather more health related findings. Although this trial did not reach its goal of a 25% reduction in prostate cancer, it has shown that the previous findings concerning vitamin E & C in the prevention of prostate cancer were not verifiable. Six men, who were not having regular prostate exams and PSAs, were found to have early stage prostate cancer. To read more about this trial, please visit the NCI website. 

If you have been or are enrolled in this trial, we would love to hear about your personal experience and any thoughts you have about this or other prevention trials.

Tags: cancer prevention, clinical trials, National Cancer Institute, Prevention, Prostate Cancer, Screening, SELECT, Selenium, Treatment, vitamin C, Vitamin E

This entry was posted on Monday, May 11th, 2009 at 2:18 pm and is filed under Prostate Cancer, Research and Genetics. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.