Selection of Surrogate Endpoint Biomarkers to Evaluate the Efficacy of Lycopene/Tomatoes for the Prevention/Progression of Prostate Cancer

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Abstract
The use of surrogate endpoint biomarkers (SEBs)3 is essential to the crafting of cost-effective clinical trials to evaluate not only the efficacy of lycopene/tomatoes but also combinations of bioactive compounds. An SEB can be defined as a measurable biological process or molecule that is closely linked to the progression pathway to invasive cancer and that undergoes change in concert with neoplastic regression (1). The closer the SEB is in the pathway to prostate cancer expression or progression, the more likely its predictive value. High-grade prostate intraepithelial neoplasia (HGPIN), microvessel density, and prostate-specific antigen (PSA) have been exploited for these purposes, and their sensitivity and specificity in predicting clinically relevant prostate cancer can be determined. Modulation of a number of signaling pathways distinguishes neoplastic cells, and patterns or combinations of these changes may be more predictive of cancer progression. The sensitivity and specificity of SEBs can be assessed through their incorporation in case-control and longitudinal studies in men at higher risk and men diagnosed with prostate cancer.

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