Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naïve Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study

There is growing interest to implement multiparametric magnetic resonance imaging (mpMRI) and MR-guided biopsy (MRGB) for biopsy-naïve men with suspected prostate cancer. Primary objective was to compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biops...

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Veröffentlicht in:European urology 2019-04, Vol.75 (4), p.570-578
Hauptverfasser: van der Leest, Marloes, Cornel, Erik, Israël, Bas, Hendriks, Rianne, Padhani, Anwar R., Hoogenboom, Martijn, Zamecnik, Patrik, Bakker, Dirk, Setiasti, Anglita Yanti, Veltman, Jeroen, van den Hout, Huib, van der Lelij, Hans, van Oort, Inge, Klaver, Sjoerd, Debruyne, Frans, Sedelaar, Michiel, Hannink, Gerjon, Rovers, Maroeska, Hulsbergen-van de Kaa, Christina, Barentsz, Jelle O.
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container_end_page 578
container_issue 4
container_start_page 570
container_title European urology
container_volume 75
creator van der Leest, Marloes
Cornel, Erik
Israël, Bas
Hendriks, Rianne
Padhani, Anwar R.
Hoogenboom, Martijn
Zamecnik, Patrik
Bakker, Dirk
Setiasti, Anglita Yanti
Veltman, Jeroen
van den Hout, Huib
van der Lelij, Hans
van Oort, Inge
Klaver, Sjoerd
Debruyne, Frans
Sedelaar, Michiel
Hannink, Gerjon
Rovers, Maroeska
Hulsbergen-van de Kaa, Christina
Barentsz, Jelle O.
description There is growing interest to implement multiparametric magnetic resonance imaging (mpMRI) and MR-guided biopsy (MRGB) for biopsy-naïve men with suspected prostate cancer. Primary objective was to compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biopsy-naïve men with prostate-specific antigen levels of ≥3ng/ml. A prospective, multicenter, powered, comparative effectiveness study included 626 biopsy-naïve patients (from February 2015 to February 2018). All patients underwent prebiopsy mpMRI followed by systematic TRUSGB. Men with suspicious lesions on mpMRI also underwent MRGB prior to TRUSGB. MRGB was performed using the in-bore approach. Clinically significant prostate cancer (csPCa) was defined as grade group ≥2 (Gleason score ≥3+4) in any core. The main secondary objectives were the number of men who could avoid biopsy after nonsuspicious mpMRI, the number of biopsy cores taken, and oncologic follow-up. Differences in proportions were tested using McNemar's test with adjusted Wald confidence intervals for differences of proportions with matched pairs. The MRI pathway detected csPCa in 159/626 (25%) patients and insignificant prostate cancer (insignPCa) in 88/626 patients (14%). TRUSGB detected csPCa in 146/626 patients (23%) and insignPCa in 155/626 patients (25%). Relative sensitivity of the MRI pathway versus the TRUSGB pathway was 1.09 for csPCa (p=0.17) and 0.57 for insignPCa (p
doi_str_mv 10.1016/j.eururo.2018.11.023
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Primary objective was to compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biopsy-naïve men with prostate-specific antigen levels of ≥3ng/ml. A prospective, multicenter, powered, comparative effectiveness study included 626 biopsy-naïve patients (from February 2015 to February 2018). All patients underwent prebiopsy mpMRI followed by systematic TRUSGB. Men with suspicious lesions on mpMRI also underwent MRGB prior to TRUSGB. MRGB was performed using the in-bore approach. Clinically significant prostate cancer (csPCa) was defined as grade group ≥2 (Gleason score ≥3+4) in any core. The main secondary objectives were the number of men who could avoid biopsy after nonsuspicious mpMRI, the number of biopsy cores taken, and oncologic follow-up. Differences in proportions were tested using McNemar's test with adjusted Wald confidence intervals for differences of proportions with matched pairs. The MRI pathway detected csPCa in 159/626 (25%) patients and insignificant prostate cancer (insignPCa) in 88/626 patients (14%). TRUSGB detected csPCa in 146/626 patients (23%) and insignPCa in 155/626 patients (25%). Relative sensitivity of the MRI pathway versus the TRUSGB pathway was 1.09 for csPCa (p=0.17) and 0.57 for insignPCa (p&lt;0.0001). The total number of biopsy cores reduced from 7512 to 849 (–89%). The MRI pathway enabled biopsy avoidance in 309/626 (49%) patients due to nonsuspicious mpMRI. Immediate TRUSGB detected csPCa in only 3% (10/309) of these patients, increasing to 4% (13/309) with 1-yr follow-up. At the same time, TRUSGB would overdetect insignPCa in 20% (63/309). “Focal saturation” by four additional perilesional cores to MRGB improved the detection of csPCa in 21/317 (7%) patients. Compared with the literature, our proportion of nonsuspicious mpMRI cases is significantly higher (27–36% vs 49%) and that of equivocal cases is lower (15–28% vs 6%). This is probably due to the high-quality standard in this study. Therefore, a limitation is the duplication of these results in less experienced centers. In biopsy-naïve men, the MRI pathway compared with the TRUSGB pathway results in an identical detection rate of csPCa, with significantly fewer insignPCa cases. In this high-quality standard study, almost half of men have nonsuspicious MRI, which is higher compared with other studies. Not performing TRUS biopsy is at the cost of missing csPCa only in 4%. We compared magnetic resonance imaging (MRI) with MRI-guided biopsy against standard transrectal ultrasound biopsy for the diagnosis of prostate cancer in biopsy-naïve men. Our results show that patients can benefit from MRI because biopsy may be omitted in half of men, and fewer indolent cancers are detected, without compromising the detection of harmful disease. Men also need fewer needles to make a diagnosis. In biopsy-naïve patients, a magnetic resonance imaging (MRI) pathway compared with a transrectal ultrasound-guided biopsy pathway significantly reduces the detection rate of insignificant prostate cancer without impairing the detection rate of clinically significant prostate cancer. There is a potential to reduce the number of men requiring biopsy after nonsuspicious MRI to half, with an acceptable underdetection rate of 4%.</description><identifier>ISSN: 0302-2838</identifier><identifier>EISSN: 1873-7560</identifier><identifier>DOI: 10.1016/j.eururo.2018.11.023</identifier><identifier>PMID: 30477981</identifier><language>eng</language><publisher>Switzerland: Elsevier B.V</publisher><subject>Magnetic resonance-guided biopsy ; Multiparametric magnetic resonance imaging ; Prostate cancer ; Prostate Imaging Reporting and Data System ; Transrectal ultrasound-guided biopsy</subject><ispartof>European urology, 2019-04, Vol.75 (4), p.570-578</ispartof><rights>2018 The Authors</rights><rights>Copyright © 2018 The Authors. Published by Elsevier B.V. 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The MRI pathway detected csPCa in 159/626 (25%) patients and insignificant prostate cancer (insignPCa) in 88/626 patients (14%). TRUSGB detected csPCa in 146/626 patients (23%) and insignPCa in 155/626 patients (25%). Relative sensitivity of the MRI pathway versus the TRUSGB pathway was 1.09 for csPCa (p=0.17) and 0.57 for insignPCa (p&lt;0.0001). The total number of biopsy cores reduced from 7512 to 849 (–89%). The MRI pathway enabled biopsy avoidance in 309/626 (49%) patients due to nonsuspicious mpMRI. Immediate TRUSGB detected csPCa in only 3% (10/309) of these patients, increasing to 4% (13/309) with 1-yr follow-up. At the same time, TRUSGB would overdetect insignPCa in 20% (63/309). “Focal saturation” by four additional perilesional cores to MRGB improved the detection of csPCa in 21/317 (7%) patients. Compared with the literature, our proportion of nonsuspicious mpMRI cases is significantly higher (27–36% vs 49%) and that of equivocal cases is lower (15–28% vs 6%). This is probably due to the high-quality standard in this study. Therefore, a limitation is the duplication of these results in less experienced centers. In biopsy-naïve men, the MRI pathway compared with the TRUSGB pathway results in an identical detection rate of csPCa, with significantly fewer insignPCa cases. In this high-quality standard study, almost half of men have nonsuspicious MRI, which is higher compared with other studies. Not performing TRUS biopsy is at the cost of missing csPCa only in 4%. We compared magnetic resonance imaging (MRI) with MRI-guided biopsy against standard transrectal ultrasound biopsy for the diagnosis of prostate cancer in biopsy-naïve men. Our results show that patients can benefit from MRI because biopsy may be omitted in half of men, and fewer indolent cancers are detected, without compromising the detection of harmful disease. Men also need fewer needles to make a diagnosis. In biopsy-naïve patients, a magnetic resonance imaging (MRI) pathway compared with a transrectal ultrasound-guided biopsy pathway significantly reduces the detection rate of insignificant prostate cancer without impairing the detection rate of clinically significant prostate cancer. 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Primary objective was to compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biopsy-naïve men with prostate-specific antigen levels of ≥3ng/ml. A prospective, multicenter, powered, comparative effectiveness study included 626 biopsy-naïve patients (from February 2015 to February 2018). All patients underwent prebiopsy mpMRI followed by systematic TRUSGB. Men with suspicious lesions on mpMRI also underwent MRGB prior to TRUSGB. MRGB was performed using the in-bore approach. Clinically significant prostate cancer (csPCa) was defined as grade group ≥2 (Gleason score ≥3+4) in any core. The main secondary objectives were the number of men who could avoid biopsy after nonsuspicious mpMRI, the number of biopsy cores taken, and oncologic follow-up. Differences in proportions were tested using McNemar's test with adjusted Wald confidence intervals for differences of proportions with matched pairs. The MRI pathway detected csPCa in 159/626 (25%) patients and insignificant prostate cancer (insignPCa) in 88/626 patients (14%). TRUSGB detected csPCa in 146/626 patients (23%) and insignPCa in 155/626 patients (25%). Relative sensitivity of the MRI pathway versus the TRUSGB pathway was 1.09 for csPCa (p=0.17) and 0.57 for insignPCa (p&lt;0.0001). The total number of biopsy cores reduced from 7512 to 849 (–89%). The MRI pathway enabled biopsy avoidance in 309/626 (49%) patients due to nonsuspicious mpMRI. Immediate TRUSGB detected csPCa in only 3% (10/309) of these patients, increasing to 4% (13/309) with 1-yr follow-up. At the same time, TRUSGB would overdetect insignPCa in 20% (63/309). “Focal saturation” by four additional perilesional cores to MRGB improved the detection of csPCa in 21/317 (7%) patients. Compared with the literature, our proportion of nonsuspicious mpMRI cases is significantly higher (27–36% vs 49%) and that of equivocal cases is lower (15–28% vs 6%). This is probably due to the high-quality standard in this study. Therefore, a limitation is the duplication of these results in less experienced centers. In biopsy-naïve men, the MRI pathway compared with the TRUSGB pathway results in an identical detection rate of csPCa, with significantly fewer insignPCa cases. In this high-quality standard study, almost half of men have nonsuspicious MRI, which is higher compared with other studies. Not performing TRUS biopsy is at the cost of missing csPCa only in 4%. We compared magnetic resonance imaging (MRI) with MRI-guided biopsy against standard transrectal ultrasound biopsy for the diagnosis of prostate cancer in biopsy-naïve men. Our results show that patients can benefit from MRI because biopsy may be omitted in half of men, and fewer indolent cancers are detected, without compromising the detection of harmful disease. Men also need fewer needles to make a diagnosis. In biopsy-naïve patients, a magnetic resonance imaging (MRI) pathway compared with a transrectal ultrasound-guided biopsy pathway significantly reduces the detection rate of insignificant prostate cancer without impairing the detection rate of clinically significant prostate cancer. There is a potential to reduce the number of men requiring biopsy after nonsuspicious MRI to half, with an acceptable underdetection rate of 4%.</abstract><cop>Switzerland</cop><pub>Elsevier B.V</pub><pmid>30477981</pmid><doi>10.1016/j.eururo.2018.11.023</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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source Elsevier ScienceDirect Journals
subjects Magnetic resonance-guided biopsy
Multiparametric magnetic resonance imaging
Prostate cancer
Prostate Imaging Reporting and Data System
Transrectal ultrasound-guided biopsy
title Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naïve Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study
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