Novel VLP Adjuvant based on the VesiVax system

DESCRIPTION (provided by applicant): Over one million prostate biopsies are performed in the US each year to diagnose approximately 200,000 cases of prostate cancer. The majority of these biopsies are performed needlessly. The overall objective of this project is to develop a secondary prostate cancer diagnostic test that can be performed on men with elevated PSA in order to identify patients in need of prostate biopsies. Towards this objective, we have identified 12 novel markers that are methylated in prostate cancer. We also developed detection assays using quantitative PCR and termination-coupled linear amplification (TCLA). TCLA offers improved sensitivity and specificity when applied to DNA from limited sources such as circulating DNA. A PCA test based on the analysis of methylated markers should reduce the number of repeat biopsies by at least 50% and is commercially valuable as an additional tool to improve prostate cancer diagnosis. In this prospective study, we propose to analyze the methylation ofthe panel of markers in urine DNA from patients with elevated PSA. If we successfully detect prostate cancer with 85% sensitivity and specificity, we will undertake a large validation study during Phase II in preparation for a clinical trial. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Over one million prostate biopsies are performed each year in the US on men with elevated PSA leading to the diagnosis of about 180,000 cases of prostate cancer. The majority of the biopsies are performed onmen who do not suffer from cancer. The aim of this study is to develop a diagnostic test that can detect molecular markers associated with prostate cancer in urine DNA in order to reduce the number of unnecessary biopsies.