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The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0-72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3-82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.

Objectives: To evaluate the impact of susceptibility artifacts from hip prosthesis on cancer detection rate (CDR) in prostate MRI., Materials and Methods: This three-center retrospective study included prostate MRI studies for patients without known prostate cancer between 2017 and 2021. Exams with hip prosthesis were searched on MRI reports. The degree of susceptibility artifact on diffusion-weighted images was retrospectively categorized into mild, moderate, and severe (> 66%, 33-66%, and < 33% of the prostate volume are evaluable) by blind reviewers. CDR was defined as the number of exams with Gleason score ≥7 detected by MRI (PI-RADS ≥3) divided by the total number of exams. For each artifact grade, control exams without hip prosthesis were matched (1:6 match), and CDR was compared. The degree of CDR reduction was evaluated with ratio, and influential factors were evaluated by expanding the equation., Results: Hip arthroplasty was present in 548 (4.8%) of the 11,319 MRI exams. CDR of the cases and matched control exams for each artifact grade were as follows: mild (n = 238), 0.27 vs 0.25, CDR ratio = 1.09 [95% CI: 0.87-1.37]; moderate (n = 143), 0.18 vs 0.27, CDR ratio = 0.67 [95% CI: 0.46-0.96]; severe (n = 167), 0.22 vs 0.28, CDR ratio = 0.80 [95% CI: 0.59-1.08]. When moderate and severe artifact grades were combined, CDR ratio was 0.74 [95% CI: 0.58-0.93]. CDR reduction was mostly attributed to the increased frequency of PI-RADS 1-2., Conclusion: With moderate to severe susceptibility artifacts from hip prosthesis, CDR was decreased to 74% compared to the matched control., Clinical Relevance Statement: Moderate to severe susceptibility artifacts from hip prosthesis may cause a non-negligible CDR reduction in prostate MRI. Expanding indications for systematic prostate biopsy may be considered when PI-RADS 1-2 was assigned., Key Points: • We proposed cancer detection rate as a diagnostic performance metric in prostate MRI. • With moderate to severe susceptibility artifacts secondary to hip arthroplasty, cancer detection rate decreased to 74% compared to the matched control. • Expanding indications for systematic prostate biopsy may be considered when PI-RADS 1-2 is assigned., (© 2023. The Author(s), under exclusive licence to European Society of Radiology.)

Objective: Automated surgical step recognition (SSR) using AI has been a catalyst in the "digitization" of surgery. However, progress has been limited to laparoscopy, with relatively few SSR tools in endoscopic surgery. This study aimed to create a SSR model for transurethral resection of bladder tumors (TURBT), leveraging a novel application of transfer learning to reduce video dataset requirements., Materials and Methods: Retrospective surgical videos of TURBT were manually annotated with the following steps of surgery: primary endoscopic evaluation, resection of bladder tumor, and surface coagulation. Manually annotated videos were then utilized to train a novel AI computer vision algorithm to perform automated video annotation of TURBT surgical video, utilizing a transfer-learning technique to pre-train on laparoscopic procedures. Accuracy of AI SSR was determined by comparison to human annotations as the reference standard., Results: A total of 300 full-length TURBT videos (median 23.96 min; IQR 14.13-41.31 min) were manually annotated with sequential steps of surgery. One hundred and seventy-nine videos served as a training dataset for algorithm development, 44 for internal validation, and 77 as a separate test cohort for evaluating algorithm accuracy. Overall accuracy of AI video analysis was 89.6%. Model accuracy was highest for the primary endoscopic evaluation step (98.2%) and lowest for the surface coagulation step (82.7%)., Conclusion: We developed a fully automated computer vision algorithm for high-accuracy annotation of TURBT surgical videos. This represents the first application of transfer-learning from laparoscopy-based computer vision models into surgical endoscopy, demonstrating the promise of this approach in adapting to new procedure types., Competing Interests: AA, MZ, OB, TW, and DA were employed by Theator Inc. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Deol, Tollefson, Antolin, Zohar, Bar, Ben-Ayoun, Mynderse, Lomas, Avant, Miller, Elliott, Boorjian, Wolf, Asselmann and Khanna.)

Purpose: The aim of this study was to evaluate the utility of cancer detection rate (CDR) and abnormal interpretation rate (AIR) in prostate MRI for patients with low-grade prostate cancer (PCa)., Methods: This three-center retrospective study included patients who underwent prostate MRI from 2017 to 2021 with known low-grade PCa (Gleason score 6) without prior treatment. Patient-level highest Prostate Imaging Reporting & Data System (PI-RADS®) score and pathologic diagnosis within 1 year after MRI were used to evaluate the diagnostic performance of prostate MRI in detecting clinically significant PCa (csPCa; Gleason score ≥ 7). The metrics AIR, CDR, and CDR adjusted for pathologic confirmation rate were calculated. Radiologist-level AIR-CDR plots were shown. Simulation AIR-CDR lines were created to assess the effects of different diagnostic performances of prostate MRI and the prevalence of csPCa., Results: A total of 3,207 examinations were interpreted by 33 radiologists. Overall AIR, CDR, and CDR adjusted for pathologic confirmation rate at PI-RADS 3 to 5 (PI-RADS 4 and 5) were 51.7% (36.5%), 22.1% (18.8%), and 30.7% (24.6%), respectively. Radiologist-level AIR and CDR at PI-RADS 3 to 5 (PI-RADS 4 and 5) were in the 36.8% to 75.6% (21.9%-57.5%) range and the 16.3%-28.7% (10.9%-26.5%) range, respectively. In the simulation, changing parameters of diagnostic performance or csPCa prevalence shifted the AIR-CDR line., Conclusions: The authors propose CDR and AIR as performance metrics in prostate MRI and report reference performance values in patients with known low-grade PCa. There was variability in radiologist-level AIR and CDR. Combined use of AIR and CDR could provide meaningful feedback for radiologists to improve their performance by showing relative performance to other radiologists., (Copyright © 2023 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Purpose: To report cancer detection rate (CDR) and abnormal interpretation rate (AIR) in prostate MRI performed for clinical suspicion of prostate cancer (PCa)., Materials and Methods: This retrospective single-institution, three-center study included patients who underwent MRI for clinical suspicion of PCa between 2017 and 2021. Patients with known PCa were excluded. Patient-level Prostate Imaging-Reporting and Data System (PI-RADS) score was extracted from the radiology report. AIR was defined as number of abnormal MRI (PI-RADS score 3-5) / total number of MRIs. CDR was defined as number of clinically significant PCa (csPCa: Gleason score ≥7) detected at abnormal MRI / total number of MRI. AIR, CDR, and CDR adjusted for pathology confirmation rate were calculated for each of three centers and pre-MRI biopsy status (biopsy-naive and previous negative biopsy)., Results: A total of 9,686 examinations (8,643 unique patients) were included. AIR, CDR, and CDR adjusted for pathology confirmation rate were 45.4%, 23.8%, and 27.6% for center I; 47.2%, 20.0%, and 22.8% for center II; and 42.3%, 27.2%, and 30.1% for center III, respectively. Pathology confirmation rate ranged from 81.6% to 88.0% across three centers. AIR and CDR for biopsy-naive patients were 45.5% to 52.6% and 24.2% to 33.5% across three centers, respectively, and those for previous negative biopsy were 27.2% to 39.8% and 11.7% to 14.2% across three centers, respectively., Conclusion: We reported CDR and AIR in prostate MRI for clinical suspicion of PCa. CDR needs to be adjusted for pathology confirmation rate and pre-MRI biopsy status for interfacility comparison., (Copyright © 2023 American College of Radiology. Published by Elsevier Inc. All rights reserved.)