Dataset Information

Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device.

ABSTRACT: 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.

SUBMITTER: Ball MW

PROVIDER: S-EPMC7226682 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device.

Ball Mark W MW Ross Ashley E AE Ghabili Kamyar K Kim Chunwoo C Jun Changhan C Petrisor Doru D Pan Li L Epstein Jonathan I JI Macura Katarzyna J KJ Stoianovici Dan S DS Allaf Mohamad E ME

Urology 20170719

<h4>Objective</h4>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.<h4>Methods</h4>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 ac ...[more]

PMID: 28735018

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Project description:ImportanceTransrectal, ultrasonography-guided prostate biopsy often fails to disclose the severity of underlying pathologic findings for prostate cancer. Magnetic resonance imaging (MRI)-guided biopsy may improve the characterization of prostate pathologic results, but few studies have examined its use for the decision to enter active surveillance.ObjectiveTo evaluate whether confirmatory biopsy findings by MRI guidance are associated with the risk of pathologic disease upgrading among patients with prostate cancer during active surveillance.Design, settings, and participantsThis retrospective cohort study used prospectively obtained registry data from 332 men with prostate cancer of Gleason grade group (GG) 2 or lower who were referred for active surveillance at a large academic medical center from January 1, 2009, through December 31, 2017.ExposuresAll confirmatory and follow-up biopsies were performed using MRI guidance with an MRI-ultrasonography fusion device. Patients underwent repeated MRI-guided biopsies every 12 to 24 months. At follow-up sessions, in addition to obtaining systematic samples, lesions seen on MRI were targeted and foci of low-grade prostate cancer were obtained again using tracking technology. Active surveillance was terminated with detection of at least GG3 disease or receipt of treatment.Main outcomes and measuresThe primary outcome was upgrading to at least GG3 disease during active surveillance. Secondary outcomes were the associations of MRI lesion grade, prostate-specific antigen (PSA) level, PSA density, and biopsy method (targeted, systematic, or tracked) with the primary outcome.ResultsOf 332 patients (mean [SD] age, 62.8 [7.6] years), 39 (11.7%) upgraded to at least GG3 disease during follow-up. The incidence of upgrading was 7.9% (9 of 114) when the confirmatory biopsy finding was normal, 11.4% (20 of 175) when the finding showed GG1 disease, and 23.3% (10 of 43) when the finding was GG2 disease (P = .03). Men with GG2 disease were almost 8 times more likely to upgrade during surveillance compared with those with normal findings but only among those with low PSA density (hazard ratio [HR], 7.82; 95% CI, 2.29-26.68). A PSA density of at least 0.15 ng/mL/mL was associated with increased risk of upgrading among patients with normal findings (HR, 7.21; 95% CI, 1.98-26.24) or GG1 disease (HR, 2.86; 95% CI, 1.16 to 7.03) on confirmatory biopsy. A total of 46% of pathologic disease upgrades would have been missed if only the targeted biopsy was performed and 65% of disease upgrades were detected only with tracked biopsy.Conclusions and relevanceThe findings suggest that confirmatory biopsy with MRI guidance is significantly associated with future disease upgrading of prostate cancer, especially when combined with PSA density, and should be considered as an appropriate entry point for active surveillance. Systematic and targeted biopsies were additive in detection of clinically significant cancers. Repeated biopsy at sites at which findings were previously abnormal (tracking biopsy) facilitated detection of cancers not suitable for continued active surveillance.

Dataset Information

Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device.

Publications

Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device.

Similar Datasets

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