ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation

The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.

The purpose of this study is to collect information on prostate biopsies using the ClariCore System. The ClariCore System is designed to improve how the biopsies are being collected from the prostate by using light sensors (fiber optics) that can see changes in the prostate tissue. Researchers will study the information collected from the light sensors to study a method that has been developed to tell the difference between normal and suspicious (possibly cancerous) prostate tissue during the biopsy. This information will be given to the doctor in real-time. From this study, researchers hope to learn if this method can tell the difference between normal and suspicious prostate tissue, and if this can improve the evaluation of prostate tissue (biopsies).