SELENIUM AND VITAMIN E CANCER PREVENTION TRIAL (SELECT) FOR PROSTATE CANCER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Definitive prevention trials aimed at breast cancer and prostate cancer were spawned simultaneously in 1993 in the Breast Cancer Prevention Trial (BCPT) and Prostate Cancer Prevention trial (PCPT), respectively. The Southwest Oncology Group (SWOG) launched the offspring of the PCPT in July of 2000 in the form of the Selenium and Vitamin E Prostate Cancer Prevention trials (SELECT). The 1998 report of Prostate Cancer Progress Review Group (PRG) highlighted the issue of prostate cancer prevention, specifically citing the promising epidemiological indication for the use of micronutrients selenium and vitamin E in this setting. According to the Southwest Oncology Group, in reference to both selenium and vitamin E, the strongest evidence for their potential roles in preventing prostate cancer comes from secondary findings of two randomized, placebo-controlled clinical trials. The development of these two supplements has arrived at the stage where a randomized, placebo-controlled intervention is needed to test the primary hypothesis regarding these supplements' prostate cancer chemoprevention effects. Prostate cancer has been the most common malignant tumor (excluding non-melanoma skin cancer) in U.S. men for the last decade. The estimate lifetime risk of developing prostate cancer is 16.6% for Caucasian males and 18.1% for African-American males. The lifetime risk of dying from prostate cancer is 3.5% for Caucasian and 4.3% for African Americans. The SELECT trial had an ambitious recruitment goal of 32,400 and proposes to follow men for up to 12 years. It is hoped that a twenty- percent participation rate among African American males will be attained. A lower age eligibility criterion is the specified for African Americans due to the incidence of an earlier onset of the disease in this ethnic population. While prostate cancer is the primary focus of this trial, secondary objectives will assess the effect of selenium and vitamin E on the incidence of other cancers including lung, colorectal and all cancers combined. Due to rapid accrual this study will close to recruitment late June 2004 after which, follow up and adherence monitoring will become paramount. Companion studies regarding lung function and early detection of colorectal cancer have been proposed and may utilize the GCRC.