To evaluate safety and feasibility in a first in human trial of direct MRI-guided prostate biopsy using a novel robotic device.
MrBot is an MRI-safe robotic device constructed entirely of nonconductive, nonmetallic, and nonmagnetic materials, developed by our group. A safety and feasibility clinical trial was designed to assess the safety and feasibility of direct MRI-guided biopsy with MrBot and determine its targeting accuracy. Men with elevated PSA, prior negative prostate biopsy and cancer suspicious region (CSR) on MRI were enrolled in the study. Biopsies targeting CSR's in addition to sextant locations were performed.
Five men underwent biopsy with MrBot. Two men required Foley catheter insertion after the procedure, with no other complications or adverse events. Even though this was not a study designed to detect prostate cancer, biopsies confirmed the presence of clinically significant cancer in 2 patients. On a total of 30 biopsy sites, the robot achieved an MRI-based targeting accuracy of 2.55mm and precision of 1.59 mm normal to the needle, with no trajectory corrections and no unsuccessful attempts to target a site.
Robot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that clinically significant prostate cancer (≥5mm radius, 0.5 cm(3)) depicted in MRI may be accurately targeted. Direct confirmation of needle placement in the CSR may present an advantage over fusion-based technology, and gives more confidence in a negative biopsy result. Additional study is warranted to evaluate the efficacy of this approach.
Urology. 2017 Jul 19 [Epub ahead of print]
Mark W Ball, Ashley E Ross, Kamyar Ghabili, Chunwoo Kim, Changhan Jun, Doru Petrisor, Li Pan, Jonathan I Epstein, Katarzyna J Macura, Dan S Stoianovici, Mohamad E Allaf
James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD., Siemens Healthcare, Baltimore, MD., Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD., Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD., James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address: .