Method and device for the detection and characterization of inhomogeneities of the prostate : the Quantitative Digital Rectal Exam (QDRE)

Abstract

Prostate cancer is the most common cancer diagnosed in American males. However, current methods of screening for prostate cancer have low sensitivity and specificity for diagnosing patients with prostate cancer. A new methodology of screening for prostate cancer was formulated by developing a method and device to quantify the traditional digital rectal exam. The Quantitative Digital Rectal Exam (QDRE) measures the relative compliance at discrete locations on the posterior surface of the prostate. The Test Head of the QDRE indents the prostate and measures the pressure distribution across a rigid disk using an matrix of pressure transducers. The position of the Test Head is tracked by the Location Tracking System. The Mapping Algorithm analyzes each Test Head measurement and the position information recorded by the Location Tracking System, and generates a map showing magnitudes and locations of relative compliance across the measured surface of the prostate. A proof of concept test used a mock-up of the Test Head, a mechanical Location Tracking System and a rudimentary Mapping Algorithm to examine a clinical model of the prostate which had one nodule. The results were presented as a map of the measured surface of the prostate model, and results showed the size of the nodule (6.4 mm in diameter) and the relative compliance of the nodule (0.08 relative to the healthy tissue of the model), as well as the location within the measured surface.