A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy.

Autor: Pavlovich CP; The Brady Urological Institute The Johns Hopkins School of Medicine Baltimore MD USA., Hyndman ME; Southern Alberta Institute of Urology and Prostate Cancer Centre Calgary AB Canada., Eure G; Urology of Virginia Department of Urology Eastern Virginia Medical School Virginia Beach VA USA., Ghai S; Joint Department of Medical imaging University Health Network University of Toronto Toronto ON Canada., Caumartin Y; Centre de Recherche en Cancérologie de l'Université Laval Quebec City QC Canada., Herget E; Southern Alberta Institute of Urology and Prostate Cancer Centre Calgary AB Canada., Young JD; Urology of Virginia Department of Urology Eastern Virginia Medical School Virginia Beach VA USA., Wiseman D; Southern Alberta Institute of Urology and Prostate Cancer Centre Calgary AB Canada., Caughlin C; Southern Alberta Institute of Urology and Prostate Cancer Centre Calgary AB Canada., Gray R; Southern Alberta Institute of Urology and Prostate Cancer Centre Calgary AB Canada., Wason S; Urology of Virginia Department of Urology Eastern Virginia Medical School Virginia Beach VA USA., Mettee L; The Brady Urological Institute The Johns Hopkins School of Medicine Baltimore MD USA., Lodde M; Centre de Recherche en Cancérologie de l'Université Laval Quebec City QC Canada., Toi A; Joint Department of Medical imaging University Health Network University of Toronto Toronto ON Canada., Dujardin T; Centre de Recherche en Cancérologie de l'Université Laval Quebec City QC Canada., Lance R; Urology of Virginia Department of Urology Eastern Virginia Medical School Virginia Beach VA USA., Schatz SM; Houston Methodist Institute for Academic Medicine Houston TX USA., Fabrizio M; Urology of Virginia Department of Urology Eastern Virginia Medical School Virginia Beach VA USA., Malcolm JB; Urology of Virginia Department of Urology Eastern Virginia Medical School Virginia Beach VA USA., Fradet V; Centre de Recherche en Cancérologie de l'Université Laval Quebec City QC Canada.
Jazyk: angličtina
Zdroj: BJUI compass [BJUI Compass] 2020 Nov 28; Vol. 2 (2), pp. 126-133. Date of Electronic Publication: 2020 Nov 28 (Print Publication: 2021).
DOI: 10.1002/bco2.59
Abstrakt: Objectives: To study high-frequency 29 MHz transrectal side-fire micro-ultrasound (micro-US) for the detection of clinically significant prostate cancer (csPCa) on prostate biopsy, and validate an image interpretation protocol for micro-US imaging of the prostate.
Materials and Methods: A prospective randomized clinical trial was performed where 1676 men with indications for prostate biopsy and without known prostate cancer were randomized 1:1 to micro-US vs conventional end-fire ultrasound (conv-US) transrectal-guided prostate biopsy across five sites in North America. The trial was split into two phases, before and after training on a micro-US image interpretation protocol that was developed during the trial using data from the pre-training micro-US arm. Investigators received a standardized training program mid-trial, and the post-training micro-US data were used to examine the training effect.
Results: Detection of csPCa (the primary outcome) was no better with the first-generation micro-US system than with conv-US in the overall population (34.6% vs 36.6%, respectively, P  = .21). Data from the first portion of the trial were, however, used to develop an image interpretation protocol termed PRI-MUS in order to address the lack of understanding of the appearance of cancer under micro-US. Micro-US sensitivity in the post-training group improved to 60.8% from 24.6% ( P  < .01), while specificity decreased (from 84.2% to 63.2%). Detection of csPCa in the micro-US arm increased by 7% after training (32% to 39%, P  < .03), but training instituted mid-trial did not affect the overall results of the comparison between arms.
Conclusion: Micro-US provided no clear benefit over conv-US for the detection of csPCa at biopsy. However, it became evident during the trial that training and increasing experience with this novel technology improved the performance of this first-generation system.
Competing Interests: Dr. Pavlovich reports grants and personal fees from Exact Imaging during the conduct of the study.
(© 2020 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.)
Databáze: MEDLINE
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