Objective To evaluate safety and feasibility in a first-in-human trial of a direct magnetic resonance imaging (MRI)-guided prostate biopsy using a novel robotic device. Methods MrBot is an MRI-safe robotic device constructed entirely with nonconductive, nonmetallic, and nonmagnetic materials and developed by our group. A safety and feasibility clinical trial was designed to assess the safety and feasibility of a direct MRI-guided biopsy with MrBot and to determine its targeting accuracy. Men with elevated prostate-specific antigen levels, prior negative prostate biopsies, and cancer-suspicious regions (CSRs) on MRI were enrolled in the study. Biopsies targeting CSRs, in addition to sextant locations, were performed. Results 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 a clinically significant cancer in 2 patients. On a total of 30 biopsy sites, the robot achieved an MRI-based targeting accuracy of 2.55 mm and a precision of 1.59 mm normal to the needle, with no trajectory corrections and no unsuccessful attempts to target a site. Conclusion Robot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that a clinically significant prostate cancer (≥5-mm radius, 0.5 cm3) 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.
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