This protocol for the use of human subjects in a prospective observational clinical trial of a new diagnostic test for prostate cancer that is based on collection and analyzes tumor stroma or microenvironment tissue. No treatment and no devices other than standard of care are proposed. Consenting patients of the UCIMC and the Orange County Urology Associates (OCUA) will be asked to provide an extra or 13th core of tissue during their clinical 12-core biopsy procedure that will be used for research purposes and patient diagnoses, as necessary. All collected tissue will be analyzed in the UCI Pathology Molecular Genetics CLIA lab. The data will be used to determine the probability that the biopsy contains tumor using the SPECS algorithm for determination of “presence of tumor”. In order to validate the accuracy of this diagnosis, the frequency of positive and negative diagnoses will be compared to the true frequency of diagnosis as defined by clinical pathology diagnoses observed in repeat biopsy results of the same cases, i.e. by Chi-square test. All patients will be followed by shadow chart development by entry into the IRB-approved HS# 2005-4806, Dr. Mercola UCI SPECS prostate program database, which is hosted on two servers one maintained by the HSIS group and the other, in compliance with disaster preparedness, is maintained at the Vaccine Research Institute in San Diego, CA 92121 by a co-PI of this study, M. McClelland who is also a UCI Pathology Visiting Professor with an experimental program in Pathology. As will be summarized under risk assessment, the protocol actually reduces the risk of adverse events affecting participating patients by providing clinical data on the 13th biopsy thereby minimizing the risk of a false negative biopsy, now rated at ~30%.
