Detection of clinically significant prostate cancer in biopsy‐naïve men: direct comparison of systematic biopsy, multiparametric MRI‐ and contrast‐ultrasound‐dispersion imaging‐targeted biopsy

Objectives To compare and evaluate a multiparametric magnetic resonance imaging (mpMRI)‐targeted biopsy (TBx) strategy, contrast‐ultrasound‐dispersion imaging (CUDI)‐TBx strategy and systematic biopsy (SBx) strategy for the detection of clinically significant prostate cancer (csPCa) in biopsy‐naïve...

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Veröffentlicht in:BJU international 2020-10, Vol.126 (4), p.481-493
Hauptverfasser: Mannaerts, Christophe K., Engelbrecht, Marc R.W., Postema, Arnoud W., Kollenburg, Rob A.A., Hoeks, Caroline M.A., Savci‐Heijink, Cemile Dilara, Van Sloun, Ruud J.G., Wildeboer, Rogier R., De Reijke, Theo M., Mischi, Massimo, Wijkstra, Hessel
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container_end_page 493
container_issue 4
container_start_page 481
container_title BJU international
container_volume 126
creator Mannaerts, Christophe K.
Engelbrecht, Marc R.W.
Postema, Arnoud W.
Kollenburg, Rob A.A.
Hoeks, Caroline M.A.
Savci‐Heijink, Cemile Dilara
Van Sloun, Ruud J.G.
Wildeboer, Rogier R.
De Reijke, Theo M.
Mischi, Massimo
Wijkstra, Hessel
description Objectives To compare and evaluate a multiparametric magnetic resonance imaging (mpMRI)‐targeted biopsy (TBx) strategy, contrast‐ultrasound‐dispersion imaging (CUDI)‐TBx strategy and systematic biopsy (SBx) strategy for the detection of clinically significant prostate cancer (csPCa) in biopsy‐naïve men. Patients and Methods A prospective, single‐centre paired diagnostic study included 150 biopsy‐naïve men, from November 2015 to November 2018. All men underwent pre‐biopsy mpMRI and CUDI followed by a 12‐core SBx taken by an operator blinded from the imaging results. Men with suspicious lesions on mpMRI and/or CUDI also underwent MRI‐TRUS fusion‐TBx and/or cognitive CUDI‐TBx after SBx by a second operator. A non‐inferiority analysis of the mpMRI‐ and CUDI‐TBx strategies in comparison with SBx for International Society of Urological Pathology Grade Group [GG] ≥2 PCa in any core with a non‐inferiority margin of 1 percentage point was performed. Additional analyses for GG ≥2 PCa with cribriform growth pattern and/or intraductal carcinoma (CR/IDC), and GG ≥3 PCa were performed. Differences in detection rates were tested using McNemar’s test with adjusted Wald confidence intervals. Results After enrolment of 150 men, an interim analysis was performed. Both the mpMRI‐ and CUDI‐TBx strategies were inferior to SBx for GG ≥2 PCa detection and the study was stopped. SBx found significantly more GG ≥2 PCa: 39% (56/142), as compared with 29% (41/142) and 28% (40/142) for mpMRI‐TBx and CUDI‐TBx, respectively (P 
doi_str_mv 10.1111/bju.15093
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Patients and Methods A prospective, single‐centre paired diagnostic study included 150 biopsy‐naïve men, from November 2015 to November 2018. All men underwent pre‐biopsy mpMRI and CUDI followed by a 12‐core SBx taken by an operator blinded from the imaging results. Men with suspicious lesions on mpMRI and/or CUDI also underwent MRI‐TRUS fusion‐TBx and/or cognitive CUDI‐TBx after SBx by a second operator. A non‐inferiority analysis of the mpMRI‐ and CUDI‐TBx strategies in comparison with SBx for International Society of Urological Pathology Grade Group [GG] ≥2 PCa in any core with a non‐inferiority margin of 1 percentage point was performed. Additional analyses for GG ≥2 PCa with cribriform growth pattern and/or intraductal carcinoma (CR/IDC), and GG ≥3 PCa were performed. Differences in detection rates were tested using McNemar’s test with adjusted Wald confidence intervals. Results After enrolment of 150 men, an interim analysis was performed. Both the mpMRI‐ and CUDI‐TBx strategies were inferior to SBx for GG ≥2 PCa detection and the study was stopped. SBx found significantly more GG ≥2 PCa: 39% (56/142), as compared with 29% (41/142) and 28% (40/142) for mpMRI‐TBx and CUDI‐TBx, respectively (P &lt; 0.05). SBx found significantly more GG = 1 PCa: 14% (20/142) compared to 1% (two of 142) and 3% (four of 142) with mpMRI‐TBx and CUDI‐TBx, respectively (P &lt; 0.05). Detection of GG ≥2 PCa with CR/IDC and GG ≥3 PCa did not differ significantly between the strategies. The mpMRI‐ and CUDI‐TBx strategies were comparable in detection but the mpMRI‐TBx strategy had less false‐positive findings (18% vs 53%). Conclusions In our study in biopsy‐naïve men, the mpMRI‐ and CUDI‐TBx strategies had comparable PCa detection rates, but the mpMRI‐TBX strategy had the least false‐positive findings. Both strategies were inferior to SBx for the detection of GG ≥2 PCa, despite reduced detection of insignificant GG = 1 PCa. Both strategies did not significantly differ from SBx for the detection of GG ≥2 PCa with CR/IDC and GG ≥3 PCa.</description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/bju.15093</identifier><identifier>PMID: 32315112</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Aged ; Biopsy ; Clinical significance ; Cognitive ability ; Contrast Media ; detection ; diagnosis ; Growth patterns ; Humans ; Image-Guided Biopsy ; imaging ; Magnetic resonance imaging ; Male ; Middle Aged ; MRI ; Multiparametric Magnetic Resonance Imaging ; Neoplasm Grading ; Prospective Studies ; Prostate cancer ; prostatic neoplasms ; Prostatic Neoplasms - diagnostic imaging ; Prostatic Neoplasms - pathology ; Sensitivity and Specificity ; Ultrasonic imaging ; Ultrasonography ; Ultrasound</subject><ispartof>BJU international, 2020-10, Vol.126 (4), p.481-493</ispartof><rights>2020 The Authors BJU International © 2020 BJU International Published by John Wiley &amp; Sons Ltd</rights><rights>2020 The Authors BJU International © 2020 BJU International Published by John Wiley &amp; Sons Ltd.</rights><rights>BJUI © 2020 BJU International</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3883-562dd56476669573873abc069f2ba8f0010ded946eb12d39bf1c361c9855c4ee3</citedby><cites>FETCH-LOGICAL-c3883-562dd56476669573873abc069f2ba8f0010ded946eb12d39bf1c361c9855c4ee3</cites><orcidid>0000-0002-3824-5631 ; 0000-0003-2845-0495</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbju.15093$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbju.15093$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32315112$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mannaerts, Christophe K.</creatorcontrib><creatorcontrib>Engelbrecht, Marc R.W.</creatorcontrib><creatorcontrib>Postema, Arnoud W.</creatorcontrib><creatorcontrib>Kollenburg, Rob A.A.</creatorcontrib><creatorcontrib>Hoeks, Caroline M.A.</creatorcontrib><creatorcontrib>Savci‐Heijink, Cemile Dilara</creatorcontrib><creatorcontrib>Van Sloun, Ruud J.G.</creatorcontrib><creatorcontrib>Wildeboer, Rogier R.</creatorcontrib><creatorcontrib>De Reijke, Theo M.</creatorcontrib><creatorcontrib>Mischi, Massimo</creatorcontrib><creatorcontrib>Wijkstra, Hessel</creatorcontrib><title>Detection of clinically significant prostate cancer in biopsy‐naïve men: direct comparison of systematic biopsy, multiparametric MRI‐ and contrast‐ultrasound‐dispersion imaging‐targeted biopsy</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>Objectives To compare and evaluate a multiparametric magnetic resonance imaging (mpMRI)‐targeted biopsy (TBx) strategy, contrast‐ultrasound‐dispersion imaging (CUDI)‐TBx strategy and systematic biopsy (SBx) strategy for the detection of clinically significant prostate cancer (csPCa) in biopsy‐naïve men. Patients and Methods A prospective, single‐centre paired diagnostic study included 150 biopsy‐naïve men, from November 2015 to November 2018. All men underwent pre‐biopsy mpMRI and CUDI followed by a 12‐core SBx taken by an operator blinded from the imaging results. Men with suspicious lesions on mpMRI and/or CUDI also underwent MRI‐TRUS fusion‐TBx and/or cognitive CUDI‐TBx after SBx by a second operator. A non‐inferiority analysis of the mpMRI‐ and CUDI‐TBx strategies in comparison with SBx for International Society of Urological Pathology Grade Group [GG] ≥2 PCa in any core with a non‐inferiority margin of 1 percentage point was performed. Additional analyses for GG ≥2 PCa with cribriform growth pattern and/or intraductal carcinoma (CR/IDC), and GG ≥3 PCa were performed. Differences in detection rates were tested using McNemar’s test with adjusted Wald confidence intervals. Results After enrolment of 150 men, an interim analysis was performed. Both the mpMRI‐ and CUDI‐TBx strategies were inferior to SBx for GG ≥2 PCa detection and the study was stopped. SBx found significantly more GG ≥2 PCa: 39% (56/142), as compared with 29% (41/142) and 28% (40/142) for mpMRI‐TBx and CUDI‐TBx, respectively (P &lt; 0.05). SBx found significantly more GG = 1 PCa: 14% (20/142) compared to 1% (two of 142) and 3% (four of 142) with mpMRI‐TBx and CUDI‐TBx, respectively (P &lt; 0.05). Detection of GG ≥2 PCa with CR/IDC and GG ≥3 PCa did not differ significantly between the strategies. The mpMRI‐ and CUDI‐TBx strategies were comparable in detection but the mpMRI‐TBx strategy had less false‐positive findings (18% vs 53%). Conclusions In our study in biopsy‐naïve men, the mpMRI‐ and CUDI‐TBx strategies had comparable PCa detection rates, but the mpMRI‐TBX strategy had the least false‐positive findings. Both strategies were inferior to SBx for the detection of GG ≥2 PCa, despite reduced detection of insignificant GG = 1 PCa. Both strategies did not significantly differ from SBx for the detection of GG ≥2 PCa with CR/IDC and GG ≥3 PCa.</description><subject>Aged</subject><subject>Biopsy</subject><subject>Clinical significance</subject><subject>Cognitive ability</subject><subject>Contrast Media</subject><subject>detection</subject><subject>diagnosis</subject><subject>Growth patterns</subject><subject>Humans</subject><subject>Image-Guided Biopsy</subject><subject>imaging</subject><subject>Magnetic resonance imaging</subject><subject>Male</subject><subject>Middle Aged</subject><subject>MRI</subject><subject>Multiparametric Magnetic Resonance Imaging</subject><subject>Neoplasm Grading</subject><subject>Prospective Studies</subject><subject>Prostate cancer</subject><subject>prostatic neoplasms</subject><subject>Prostatic Neoplasms - diagnostic imaging</subject><subject>Prostatic Neoplasms - pathology</subject><subject>Sensitivity and Specificity</subject><subject>Ultrasonic imaging</subject><subject>Ultrasonography</subject><subject>Ultrasound</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU9u1TAQxiNERUthwQWQJTYg8Vo7dpyYHZQ_LSpCQlRiFzn25MlPiZPaTqvsOAI34RBd9hachHnklQUS3tjf6DefxvNl2RNGjxie42YzHbGCKn4vO2BCipVg9Nv9uzdVcj97GOOGUizI4kG2z3POCsbyg-z2LSQwyQ2eDC0xnfPO6K6bSXRr71oUPpExDDHpBASVgUCcJ40bxjj_-v7D65ufV0B68K-IdQG9iBn6UQcXF884xwS9Ts7sml6SfuqSQ0T3kALWP305QyeivcVen4KOCTVC-Bomb1FYF0cIcTun6_Xa-TUWkw5rHN_ujB9le63uIjze3YfZxft3X09OV-efP5ydvD5fGV5VfFXI3NpCilJKqYqSVyXXjaFStXmjqxa3RC1YJSQ0LLdcNS0zXDKjqqIwAoAfZs8XX9zL5QQx1b2LBrpOeximWOdccSq4LAWiz_5BN8MUPE5X50JUpVKMbqkXC2Vw0TFAW48BfxnmmtF6m3CNCdd_Ekb26c5xanqwf8m7SBE4XoBr18H8f6f6zceLxfI3QBm6tQ</recordid><startdate>202010</startdate><enddate>202010</enddate><creator>Mannaerts, Christophe K.</creator><creator>Engelbrecht, Marc R.W.</creator><creator>Postema, Arnoud W.</creator><creator>Kollenburg, Rob A.A.</creator><creator>Hoeks, Caroline M.A.</creator><creator>Savci‐Heijink, Cemile Dilara</creator><creator>Van Sloun, Ruud J.G.</creator><creator>Wildeboer, Rogier R.</creator><creator>De Reijke, Theo M.</creator><creator>Mischi, Massimo</creator><creator>Wijkstra, Hessel</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3824-5631</orcidid><orcidid>https://orcid.org/0000-0003-2845-0495</orcidid></search><sort><creationdate>202010</creationdate><title>Detection of clinically significant prostate cancer in biopsy‐naïve men: direct comparison of systematic biopsy, multiparametric MRI‐ and contrast‐ultrasound‐dispersion imaging‐targeted biopsy</title><author>Mannaerts, Christophe K. ; Engelbrecht, Marc R.W. ; Postema, Arnoud W. ; Kollenburg, Rob A.A. ; Hoeks, Caroline M.A. ; Savci‐Heijink, Cemile Dilara ; Van Sloun, Ruud J.G. ; Wildeboer, Rogier R. ; De Reijke, Theo M. ; Mischi, Massimo ; Wijkstra, Hessel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3883-562dd56476669573873abc069f2ba8f0010ded946eb12d39bf1c361c9855c4ee3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Biopsy</topic><topic>Clinical significance</topic><topic>Cognitive ability</topic><topic>Contrast Media</topic><topic>detection</topic><topic>diagnosis</topic><topic>Growth patterns</topic><topic>Humans</topic><topic>Image-Guided Biopsy</topic><topic>imaging</topic><topic>Magnetic resonance imaging</topic><topic>Male</topic><topic>Middle Aged</topic><topic>MRI</topic><topic>Multiparametric Magnetic Resonance Imaging</topic><topic>Neoplasm Grading</topic><topic>Prospective Studies</topic><topic>Prostate cancer</topic><topic>prostatic neoplasms</topic><topic>Prostatic Neoplasms - diagnostic imaging</topic><topic>Prostatic Neoplasms - pathology</topic><topic>Sensitivity and Specificity</topic><topic>Ultrasonic imaging</topic><topic>Ultrasonography</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mannaerts, Christophe K.</creatorcontrib><creatorcontrib>Engelbrecht, Marc R.W.</creatorcontrib><creatorcontrib>Postema, Arnoud W.</creatorcontrib><creatorcontrib>Kollenburg, Rob A.A.</creatorcontrib><creatorcontrib>Hoeks, Caroline M.A.</creatorcontrib><creatorcontrib>Savci‐Heijink, Cemile Dilara</creatorcontrib><creatorcontrib>Van Sloun, Ruud J.G.</creatorcontrib><creatorcontrib>Wildeboer, Rogier R.</creatorcontrib><creatorcontrib>De Reijke, Theo M.</creatorcontrib><creatorcontrib>Mischi, Massimo</creatorcontrib><creatorcontrib>Wijkstra, Hessel</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mannaerts, Christophe K.</au><au>Engelbrecht, Marc R.W.</au><au>Postema, Arnoud W.</au><au>Kollenburg, Rob A.A.</au><au>Hoeks, Caroline M.A.</au><au>Savci‐Heijink, Cemile Dilara</au><au>Van Sloun, Ruud J.G.</au><au>Wildeboer, Rogier R.</au><au>De Reijke, Theo M.</au><au>Mischi, Massimo</au><au>Wijkstra, Hessel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Detection of clinically significant prostate cancer in biopsy‐naïve men: direct comparison of systematic biopsy, multiparametric MRI‐ and contrast‐ultrasound‐dispersion imaging‐targeted biopsy</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2020-10</date><risdate>2020</risdate><volume>126</volume><issue>4</issue><spage>481</spage><epage>493</epage><pages>481-493</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>Objectives To compare and evaluate a multiparametric magnetic resonance imaging (mpMRI)‐targeted biopsy (TBx) strategy, contrast‐ultrasound‐dispersion imaging (CUDI)‐TBx strategy and systematic biopsy (SBx) strategy for the detection of clinically significant prostate cancer (csPCa) in biopsy‐naïve men. Patients and Methods A prospective, single‐centre paired diagnostic study included 150 biopsy‐naïve men, from November 2015 to November 2018. All men underwent pre‐biopsy mpMRI and CUDI followed by a 12‐core SBx taken by an operator blinded from the imaging results. Men with suspicious lesions on mpMRI and/or CUDI also underwent MRI‐TRUS fusion‐TBx and/or cognitive CUDI‐TBx after SBx by a second operator. A non‐inferiority analysis of the mpMRI‐ and CUDI‐TBx strategies in comparison with SBx for International Society of Urological Pathology Grade Group [GG] ≥2 PCa in any core with a non‐inferiority margin of 1 percentage point was performed. Additional analyses for GG ≥2 PCa with cribriform growth pattern and/or intraductal carcinoma (CR/IDC), and GG ≥3 PCa were performed. Differences in detection rates were tested using McNemar’s test with adjusted Wald confidence intervals. Results After enrolment of 150 men, an interim analysis was performed. Both the mpMRI‐ and CUDI‐TBx strategies were inferior to SBx for GG ≥2 PCa detection and the study was stopped. SBx found significantly more GG ≥2 PCa: 39% (56/142), as compared with 29% (41/142) and 28% (40/142) for mpMRI‐TBx and CUDI‐TBx, respectively (P &lt; 0.05). SBx found significantly more GG = 1 PCa: 14% (20/142) compared to 1% (two of 142) and 3% (four of 142) with mpMRI‐TBx and CUDI‐TBx, respectively (P &lt; 0.05). Detection of GG ≥2 PCa with CR/IDC and GG ≥3 PCa did not differ significantly between the strategies. The mpMRI‐ and CUDI‐TBx strategies were comparable in detection but the mpMRI‐TBx strategy had less false‐positive findings (18% vs 53%). Conclusions In our study in biopsy‐naïve men, the mpMRI‐ and CUDI‐TBx strategies had comparable PCa detection rates, but the mpMRI‐TBX strategy had the least false‐positive findings. Both strategies were inferior to SBx for the detection of GG ≥2 PCa, despite reduced detection of insignificant GG = 1 PCa. Both strategies did not significantly differ from SBx for the detection of GG ≥2 PCa with CR/IDC and GG ≥3 PCa.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32315112</pmid><doi>10.1111/bju.15093</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-3824-5631</orcidid><orcidid>https://orcid.org/0000-0003-2845-0495</orcidid><oa>free_for_read</oa></addata></record>
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subjects Aged
Biopsy
Clinical significance
Cognitive ability
Contrast Media
detection
diagnosis
Growth patterns
Humans
Image-Guided Biopsy
imaging
Magnetic resonance imaging
Male
Middle Aged
MRI
Multiparametric Magnetic Resonance Imaging
Neoplasm Grading
Prospective Studies
Prostate cancer
prostatic neoplasms
Prostatic Neoplasms - diagnostic imaging
Prostatic Neoplasms - pathology
Sensitivity and Specificity
Ultrasonic imaging
Ultrasonography
Ultrasound
title Detection of clinically significant prostate cancer in biopsy‐naïve men: direct comparison of systematic biopsy, multiparametric MRI‐ and contrast‐ultrasound‐dispersion imaging‐targeted biopsy
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