Phase I study of a new tablet-based image guided surgical system in robot-assisted radical prostatectomy.

Robot-assisted radical prostatectomy is, currently, the most commonly utilized procedure for the treatment of localized prostate cancer. Image-guided surgical systems have been proposed in the literature as a valuable tool for the better utilization of the preoperative data in theatre. In this Phase 1 trial, we tested the feasibility and safety of a new, cutting-edge tablet-based surgical imaging system designed for robot-assisted radical prostatectomy (RARP). It utilizes the preoperative MRI images of the prostate, mapping them intra-operatively, real time to the patient by magnetic tracking to fixed points of the pelvis. The system is comprised of a tablet computer with a touch screen display; a tracking system housed in a portable cart, a magnetic field generator and position sensors. It updates image data over 20 times per second to compensate with anatomical alterations during the operation. Four patients diagnosed with prostate adenocarcinoma were enrolled in this study. All four had negative surgical margins along with satisfactory functional recovery regarding continence and potency. The navigational accuracy and the real time information provided by the imaging system was mainly utilized in the more challenging parts of the operation including the apical dissection, the nerve sparing procedure and the bladder neck dissection. The system proved to be safe and its clinical efficacy is due to be assessed with a Phase II clinical study.