Clinical models for testing chemopreventative agents in prostate cancer and overview of SELECT: The selenium and vitamin E cancer prevention trial

Target populations for chemoprevention trials should include those at higher than average risk for the development of prostate cancer as defined by explicit epidemiologic and genetic criteria. Such populations include a "primary prevention" group without histologic or clinical evidence of cancer, and several clinical models of "secondary prevention;" including those with clinically evident disease prior to definitive therapy and those at high risk of recurrence after therapy based on histology and/or biochemical status. Each risk group and clinical model has potential advantages and disadvantages, and the mechanisms which underlie disease development and progression in each group may be unique. These observations give rise to many potential clinical trials of specific agents. These trials should also include collection of data on potentially confounding influences on disease development and progression. Preclinical, epidemiologic, and Phase II data suggest that both selenium and vitamin E have potential efficacy in prostate cancer prevention. The experience of the Prostate Cancer Prevention Trial (PCPT) demonstrates the interest and dedication of healthy men to long-term studies of cancer prevention. SELECT, the Selenium and Vitamin E Cancer Prevention Trial, is an intergroup phase III, randomized, double-blind, placebo-controlled, population-based clinical trial designed to test the efficacy of selenium and vitamin. E alone and in combination in the prevention of prostate cancer which builds on secondary analyses of large-scale chemoprevention trials for other cancers and the lessons of PCPT.