Development of a Novel, Non-Invasive Diagnostic Test for Prostate Cancer

Abstract : Hypothesis: The overall objective is to provide for routine clinical use a simple and reliable method for identifying patients with prostate cancer so that transrectal ultrasound guided biopsies can be restricted to men harboring PCa. Our broad strategy will involve the use of selected markers for sensitive detection of cancer cells in ejaculate. Objectives: (1) To recruit patients for a prospective clinical trial in a screening assay of patient ejaculate and urine samples from which PCa cells will be isolated by (2) immunocapture using antibodies to specific cell-surface markers and (3) detected by real-time PCR with a combination of genes upregulated in PCa. These methods will be refined for application for routine laboratory use. Logistic regression analysis will be used with the above combination of PS MA DD3 and Hepsin to determine each patient%s probability of harboring PCa. This data will be correlated with clinical data obtained by conventional diagnostic methods. Relevance: It is our strong expectation that this research will lead to provision of a simple and reliable approach for diagnosing PCa in the longer term reducing the need for the invasive imprecise and unpleasant procedure of TRUS-guided prostatic biopsies. In addition we expect that the earlier detection will be associated with and even greater proportion of cancer localised to the prostate at time of diagnosis.