A New Ultrasound Probe and Robot for Prostate Biopsy and Focal Therapy

PROJECT SUMMARY/ABSTRACT Prostate cancer (PCa) is the most commonly diagnosed type of cancer and the second leading cause of cancer related deaths among US men. The proposed project aims to improve prostate image-guided interventions (IGI) with a novel ultrasound probe and robot developed by our team, ProBot. We propose a Phase 1 clinical trial to evaluate the safety and feasibility of the new device at biopsy. We also propose to improve the technology and expand it to focal therapy of PCa. ProBot is an entirely new concept including a novel ultrasound probe and robot kinematics specifically designed for prostate IGI. A novel feature is that it does not change the deformation of the prostate gland, allowing more accurate MRI-ultrasound co-registration and needle targeting. In addition to accurate MRI targeted biopsy (TB), at systematic biopsy (SB), instead of using the usual template plan, our innovative software optimizes the plan to ensure appropriate biopsy spacing and obtain diagnosis representative of whole gland histology. ProBot will also be uniquely capable of transrectal (TR) and transperineal (TP) biopsy and focal therapies. ProBot is ready for immediate clinical assessment as proposed. It is a refined prototype and has already attained approval by the FDA for clinical trial evaluation. We recently completed 2 TR biopsy cases with ProBot with IRB approval. We propose to extend the approval for TP biopsy and perform the trial for TR and TP biopsies. Focal therapy is a promising, minimally invasive treatment strategy to selectively treat localized PCa while minimizing the side effects associated with whole gland treatment options. Focal therapies aim to deliver ablative energy to PCa lesions sampled at biopsy. Repeatably targeting a lesion between biopsy and therapy may be improved if the same device, such as ProBot, is used to guide both procedures. As a research aim, we also propose to further develop ProBot for percutaneous interstitial ablative treatment, an innovative approach to be integrated with ablative technology and tested in a future trial. ProBot is a small, lightweight (1.3Kg ultrasound probe and robot), inexpensive to manufacture device that could ultimately provide a cost-effective solution for PCa care. The ProBot allows hands-free operation of its ultrasound probe at 3D image scanning and needle targeting. This device could reduce the level of physician training and skill currently needed while minimizing the variability in outcomes among physicians, and ultimately improve the accuracy of biopsy targeting and reliability in the results of biopsy. An early-stage clinical trial is required to evaluate the safety and feasibility of the new device and biopsy approaches.