Background: Prostate biopsy false negative percentages are 21% to 47% and 16% to 30% for systematic and fused biopsy, respectively. An intuitive three-dimensional (3D) observed user interface may help reduce these percentages by providing real-time guidance and feedback during transrectal or transperineal biopsy. Materials and Methods: We track the moving prostate (including template locations and regions of interest), the transrectal ultrasound (TRUS) probe, and the biopsy device to construct a 3D environment. Users observe, aim, sample, and receive feedback in real time. Using a simulator with simulated TRUS, 48 participants performed freehand systematic prostate biopsy with traditional TRUS guidance and afterward with visualized prostate biopsy (vPBx). Results: During simulated biopsy, vPBx reduced the false negative percentage for a 0.5-mL spherical apical lesion from 52% to 2% (p < 0.001). Conclusions: Preliminary results during simulated systematic biopsy warrant retrofitting the vPBx to actual TRUS equipment as a step toward clinical trials with patients.
Keywords: biopsy; false negatives; prostate cancer; three-dimensional observation.