Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study
Whether multiparametric MRI improves the detection of clinically significant prostate cancer and avoids the need for systematic biopsy in biopsy-naive patients remains controversial. We aimed to investigate whether using this approach before biopsy would improve detection of clinically significant p...
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| Veröffentlicht in: | The lancet oncology 2019-01, Vol.20 (1), p.100-109 |
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| creator | Rouvière, Olivier Puech, Philippe Renard-Penna, Raphaële Claudon, Michel Roy, Catherine Mège-Lechevallier, Florence Decaussin-Petrucci, Myriam Dubreuil-Chambardel, Marine Magaud, Laurent Remontet, Laurent Ruffion, Alain Colombel, Marc Crouzet, Sébastien Schott, Anne-Marie Lemaitre, Laurent Rabilloud, Muriel Grenier, Nicolas Barry Delongchamps, Nicolas Boutier, Romain Bratan, Flavie Brunelle, Serge Camparo, Philippe Colin, Pierre Corréas, Jean-Michel Cornélis, François Cornud, François Cros, Fanny Descotes, Jean-Luc Eschwege, Pascal Fiard, Gaelle Fendler, Jean-Philippe Habchi, Hocine Hallouin, Philippe Khairoune, Ahmed Lang, Hervé Lebras, Yann Lefèvre, Frédéric Malavaud, Bernard Moldovan, Paul Cezar Mottet, Nicolas Mozer, Pierre Nevoux, Pierre Pagnoux, Gaele Pasticier, Gilles Portalez, Daniel Potiron, Eric Thammavong, Athivada Soto Timsit, Marc-Olivier Viller, Arnault Walz, Jochen |
| description | Whether multiparametric MRI improves the detection of clinically significant prostate cancer and avoids the need for systematic biopsy in biopsy-naive patients remains controversial. We aimed to investigate whether using this approach before biopsy would improve detection of clinically significant prostate cancer in biopsy-naive patients.
In this prospective, multicentre, paired diagnostic study, done at 16 centres in France, we enrolled patients aged 18–75 years with prostate-specific antigen concentrations of 20 ng/mL or less, and with stage T2c or lower prostate cancer. Eligible patients had been referred for prostate multiparametric MRI before a first set of prostate biopsies, with a planned interval of less than 3 months between MRI and biopsies. An operator masked to multiparametric MRI results did a systematic biopsy by obtaining 12 systematic cores and up to two cores targeting hypoechoic lesions. In the same patient, another operator targeted up to two lesions seen on MRI with a Likert score of 3 or higher (three cores per lesion) using targeted biopsy based on multiparametric MRI findings. Patients with negative multiparametric MRI (Likert score ≤2) had systematic biopsy only. The primary outcome was the detection of clinically significant prostate cancer of International Society of Urological Pathology grade group 2 or higher (csPCa-A), analysed in all patients who received both systematic and targeted biopsies and whose results from both were available for pathological central review, including patients who had protocol deviations. This study is registered with ClinicalTrials.gov, number NCT02485379, and is closed to new participants.
Between July 15, 2015, and Aug 11, 2016, we enrolled 275 patients. 24 (9%) were excluded from the analysis. 53 (21%) of 251 analysed patients had negative (Likert ≤2) multiparametric MRI. csPCa-A was detected in 94 (37%) of 251 patients. 13 (14%) of these 94 patients were diagnosed by systematic biopsy only, 19 (20%) by targeted biopsy only, and 62 (66%) by both techniques. Detection of csPCa-A by systematic biopsy (29·9%, 95% CI 24·3–36·0) and targeted biopsy (32·3%, 26·5–38·4) did not differ significantly (p=0·38). csPCa-A would have been missed in 5·2% (95% CI 2·8–8·7) of patients had systematic biopsy not been done, and in 7·6% (4·6–11·6) of patients had targeted biopsy not been done. Four grade 3 post-biopsy adverse events were reported (3 cases of prostatitis, and 1 case of urinary retention with haematuria) |
| doi_str_mv | 10.1016/S1470-2045(18)30569-2 |
| format | Article |
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In this prospective, multicentre, paired diagnostic study, done at 16 centres in France, we enrolled patients aged 18–75 years with prostate-specific antigen concentrations of 20 ng/mL or less, and with stage T2c or lower prostate cancer. Eligible patients had been referred for prostate multiparametric MRI before a first set of prostate biopsies, with a planned interval of less than 3 months between MRI and biopsies. An operator masked to multiparametric MRI results did a systematic biopsy by obtaining 12 systematic cores and up to two cores targeting hypoechoic lesions. In the same patient, another operator targeted up to two lesions seen on MRI with a Likert score of 3 or higher (three cores per lesion) using targeted biopsy based on multiparametric MRI findings. Patients with negative multiparametric MRI (Likert score ≤2) had systematic biopsy only. The primary outcome was the detection of clinically significant prostate cancer of International Society of Urological Pathology grade group 2 or higher (csPCa-A), analysed in all patients who received both systematic and targeted biopsies and whose results from both were available for pathological central review, including patients who had protocol deviations. This study is registered with ClinicalTrials.gov, number NCT02485379, and is closed to new participants.
Between July 15, 2015, and Aug 11, 2016, we enrolled 275 patients. 24 (9%) were excluded from the analysis. 53 (21%) of 251 analysed patients had negative (Likert ≤2) multiparametric MRI. csPCa-A was detected in 94 (37%) of 251 patients. 13 (14%) of these 94 patients were diagnosed by systematic biopsy only, 19 (20%) by targeted biopsy only, and 62 (66%) by both techniques. Detection of csPCa-A by systematic biopsy (29·9%, 95% CI 24·3–36·0) and targeted biopsy (32·3%, 26·5–38·4) did not differ significantly (p=0·38). csPCa-A would have been missed in 5·2% (95% CI 2·8–8·7) of patients had systematic biopsy not been done, and in 7·6% (4·6–11·6) of patients had targeted biopsy not been done. Four grade 3 post-biopsy adverse events were reported (3 cases of prostatitis, and 1 case of urinary retention with haematuria).
There was no difference between systematic biopsy and targeted biopsy in the detection of ISUP grade group 2 or higher prostate cancer; however, this detection was improved by combining both techniques and both techniques showed substantial added value. Thus, obtaining a multiparametric MRI before biopsy in biopsy-naive patients can improve the detection of clinically significant prostate cancer but does not seem to avoid the need for systematic biopsy.
French National Cancer Institute.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(18)30569-2</identifier><identifier>PMID: 30470502</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Biopsy ; Hematuria ; Humans ; Image-Guided Biopsy - adverse effects ; Image-Guided Biopsy - methods ; Life Sciences ; Magnetic resonance imaging ; Male ; Medical diagnosis ; Middle Aged ; Multiparametric Magnetic Resonance Imaging ; Prospective Studies ; Prostate - diagnostic imaging ; Prostate - pathology ; Prostate cancer ; Prostate-specific antigen ; Prostate-Specific Antigen - blood ; Prostatic Neoplasms - diagnostic imaging ; Prostatic Neoplasms - pathology ; Prostatitis ; Tumors ; Ultrasonography, Interventional ; Young Adult</subject><ispartof>The lancet oncology, 2019-01, Vol.20 (1), p.100-109</ispartof><rights>2019 Elsevier Ltd</rights><rights>Copyright © 2019 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jan 2019</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c592t-213f8db4c7a91b4923c1ffaadcc05517196b8de0710c76db9cb07816b5b3beda3</citedby><cites>FETCH-LOGICAL-c592t-213f8db4c7a91b4923c1ffaadcc05517196b8de0710c76db9cb07816b5b3beda3</cites><orcidid>0000-0003-3337-4474 ; 0000-0003-0898-9557 ; 0000-0003-1324-0356 ; 0000-0003-3393-4216 ; 0000-0002-0030-478X ; 0000-0003-0512-3459</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1470204518305692$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30470502$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-02180082$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Rouvière, Olivier</creatorcontrib><creatorcontrib>Puech, Philippe</creatorcontrib><creatorcontrib>Renard-Penna, Raphaële</creatorcontrib><creatorcontrib>Claudon, Michel</creatorcontrib><creatorcontrib>Roy, Catherine</creatorcontrib><creatorcontrib>Mège-Lechevallier, Florence</creatorcontrib><creatorcontrib>Decaussin-Petrucci, Myriam</creatorcontrib><creatorcontrib>Dubreuil-Chambardel, Marine</creatorcontrib><creatorcontrib>Magaud, Laurent</creatorcontrib><creatorcontrib>Remontet, Laurent</creatorcontrib><creatorcontrib>Ruffion, Alain</creatorcontrib><creatorcontrib>Colombel, Marc</creatorcontrib><creatorcontrib>Crouzet, Sébastien</creatorcontrib><creatorcontrib>Schott, Anne-Marie</creatorcontrib><creatorcontrib>Lemaitre, Laurent</creatorcontrib><creatorcontrib>Rabilloud, Muriel</creatorcontrib><creatorcontrib>Grenier, Nicolas</creatorcontrib><creatorcontrib>Barry Delongchamps, Nicolas</creatorcontrib><creatorcontrib>Boutier, Romain</creatorcontrib><creatorcontrib>Bratan, Flavie</creatorcontrib><creatorcontrib>Brunelle, Serge</creatorcontrib><creatorcontrib>Camparo, Philippe</creatorcontrib><creatorcontrib>Colin, Pierre</creatorcontrib><creatorcontrib>Corréas, Jean-Michel</creatorcontrib><creatorcontrib>Cornélis, François</creatorcontrib><creatorcontrib>Cornud, François</creatorcontrib><creatorcontrib>Cros, Fanny</creatorcontrib><creatorcontrib>Descotes, Jean-Luc</creatorcontrib><creatorcontrib>Eschwege, Pascal</creatorcontrib><creatorcontrib>Fiard, Gaelle</creatorcontrib><creatorcontrib>Fendler, Jean-Philippe</creatorcontrib><creatorcontrib>Habchi, Hocine</creatorcontrib><creatorcontrib>Hallouin, Philippe</creatorcontrib><creatorcontrib>Khairoune, Ahmed</creatorcontrib><creatorcontrib>Lang, Hervé</creatorcontrib><creatorcontrib>Lebras, Yann</creatorcontrib><creatorcontrib>Lefèvre, Frédéric</creatorcontrib><creatorcontrib>Malavaud, Bernard</creatorcontrib><creatorcontrib>Moldovan, Paul Cezar</creatorcontrib><creatorcontrib>Mottet, Nicolas</creatorcontrib><creatorcontrib>Mozer, Pierre</creatorcontrib><creatorcontrib>Nevoux, Pierre</creatorcontrib><creatorcontrib>Pagnoux, Gaele</creatorcontrib><creatorcontrib>Pasticier, Gilles</creatorcontrib><creatorcontrib>Portalez, Daniel</creatorcontrib><creatorcontrib>Potiron, Eric</creatorcontrib><creatorcontrib>Thammavong, Athivada Soto</creatorcontrib><creatorcontrib>Timsit, Marc-Olivier</creatorcontrib><creatorcontrib>Viller, Arnault</creatorcontrib><creatorcontrib>Walz, Jochen</creatorcontrib><creatorcontrib>MRI-FIRST Investigators</creatorcontrib><title>Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Whether multiparametric MRI improves the detection of clinically significant prostate cancer and avoids the need for systematic biopsy in biopsy-naive patients remains controversial. We aimed to investigate whether using this approach before biopsy would improve detection of clinically significant prostate cancer in biopsy-naive patients.
In this prospective, multicentre, paired diagnostic study, done at 16 centres in France, we enrolled patients aged 18–75 years with prostate-specific antigen concentrations of 20 ng/mL or less, and with stage T2c or lower prostate cancer. Eligible patients had been referred for prostate multiparametric MRI before a first set of prostate biopsies, with a planned interval of less than 3 months between MRI and biopsies. An operator masked to multiparametric MRI results did a systematic biopsy by obtaining 12 systematic cores and up to two cores targeting hypoechoic lesions. In the same patient, another operator targeted up to two lesions seen on MRI with a Likert score of 3 or higher (three cores per lesion) using targeted biopsy based on multiparametric MRI findings. Patients with negative multiparametric MRI (Likert score ≤2) had systematic biopsy only. The primary outcome was the detection of clinically significant prostate cancer of International Society of Urological Pathology grade group 2 or higher (csPCa-A), analysed in all patients who received both systematic and targeted biopsies and whose results from both were available for pathological central review, including patients who had protocol deviations. This study is registered with ClinicalTrials.gov, number NCT02485379, and is closed to new participants.
Between July 15, 2015, and Aug 11, 2016, we enrolled 275 patients. 24 (9%) were excluded from the analysis. 53 (21%) of 251 analysed patients had negative (Likert ≤2) multiparametric MRI. csPCa-A was detected in 94 (37%) of 251 patients. 13 (14%) of these 94 patients were diagnosed by systematic biopsy only, 19 (20%) by targeted biopsy only, and 62 (66%) by both techniques. Detection of csPCa-A by systematic biopsy (29·9%, 95% CI 24·3–36·0) and targeted biopsy (32·3%, 26·5–38·4) did not differ significantly (p=0·38). csPCa-A would have been missed in 5·2% (95% CI 2·8–8·7) of patients had systematic biopsy not been done, and in 7·6% (4·6–11·6) of patients had targeted biopsy not been done. Four grade 3 post-biopsy adverse events were reported (3 cases of prostatitis, and 1 case of urinary retention with haematuria).
There was no difference between systematic biopsy and targeted biopsy in the detection of ISUP grade group 2 or higher prostate cancer; however, this detection was improved by combining both techniques and both techniques showed substantial added value. Thus, obtaining a multiparametric MRI before biopsy in biopsy-naive patients can improve the detection of clinically significant prostate cancer but does not seem to avoid the need for systematic biopsy.
French National Cancer Institute.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Biopsy</subject><subject>Hematuria</subject><subject>Humans</subject><subject>Image-Guided Biopsy - adverse effects</subject><subject>Image-Guided Biopsy - methods</subject><subject>Life Sciences</subject><subject>Magnetic resonance imaging</subject><subject>Male</subject><subject>Medical diagnosis</subject><subject>Middle Aged</subject><subject>Multiparametric Magnetic Resonance Imaging</subject><subject>Prospective Studies</subject><subject>Prostate - diagnostic imaging</subject><subject>Prostate - pathology</subject><subject>Prostate cancer</subject><subject>Prostate-specific antigen</subject><subject>Prostate-Specific Antigen - blood</subject><subject>Prostatic Neoplasms - diagnostic imaging</subject><subject>Prostatic Neoplasms - pathology</subject><subject>Prostatitis</subject><subject>Tumors</subject><subject>Ultrasonography, 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of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study</title><author>Rouvière, Olivier ; Puech, Philippe ; Renard-Penna, Raphaële ; Claudon, Michel ; Roy, Catherine ; Mège-Lechevallier, Florence ; Decaussin-Petrucci, Myriam ; Dubreuil-Chambardel, Marine ; Magaud, Laurent ; Remontet, Laurent ; Ruffion, Alain ; Colombel, Marc ; Crouzet, Sébastien ; Schott, Anne-Marie ; Lemaitre, Laurent ; Rabilloud, Muriel ; Grenier, Nicolas ; Barry Delongchamps, Nicolas ; Boutier, Romain ; Bratan, Flavie ; Brunelle, Serge ; Camparo, Philippe ; Colin, Pierre ; Corréas, Jean-Michel ; Cornélis, François ; Cornud, François ; Cros, Fanny ; Descotes, Jean-Luc ; Eschwege, Pascal ; Fiard, Gaelle ; Fendler, Jean-Philippe ; Habchi, Hocine ; Hallouin, Philippe ; Khairoune, Ahmed ; Lang, Hervé ; Lebras, Yann ; Lefèvre, Frédéric ; Malavaud, Bernard ; Moldovan, Paul Cezar ; Mottet, Nicolas ; Mozer, Pierre ; Nevoux, Pierre ; Pagnoux, Gaele ; Pasticier, Gilles ; Portalez, Daniel ; Potiron, Eric ; Thammavong, Athivada Soto ; Timsit, Marc-Olivier ; Viller, Arnault ; Walz, Jochen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c592t-213f8db4c7a91b4923c1ffaadcc05517196b8de0710c76db9cb07816b5b3beda3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Biopsy</topic><topic>Hematuria</topic><topic>Humans</topic><topic>Image-Guided Biopsy - adverse effects</topic><topic>Image-Guided Biopsy - methods</topic><topic>Life Sciences</topic><topic>Magnetic resonance imaging</topic><topic>Male</topic><topic>Medical diagnosis</topic><topic>Middle Aged</topic><topic>Multiparametric Magnetic Resonance Imaging</topic><topic>Prospective Studies</topic><topic>Prostate - diagnostic imaging</topic><topic>Prostate - pathology</topic><topic>Prostate cancer</topic><topic>Prostate-specific antigen</topic><topic>Prostate-Specific Antigen - blood</topic><topic>Prostatic Neoplasms - diagnostic imaging</topic><topic>Prostatic Neoplasms - pathology</topic><topic>Prostatitis</topic><topic>Tumors</topic><topic>Ultrasonography, Interventional</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rouvière, Olivier</creatorcontrib><creatorcontrib>Puech, Philippe</creatorcontrib><creatorcontrib>Renard-Penna, Raphaële</creatorcontrib><creatorcontrib>Claudon, Michel</creatorcontrib><creatorcontrib>Roy, Catherine</creatorcontrib><creatorcontrib>Mège-Lechevallier, Florence</creatorcontrib><creatorcontrib>Decaussin-Petrucci, Myriam</creatorcontrib><creatorcontrib>Dubreuil-Chambardel, Marine</creatorcontrib><creatorcontrib>Magaud, Laurent</creatorcontrib><creatorcontrib>Remontet, Laurent</creatorcontrib><creatorcontrib>Ruffion, Alain</creatorcontrib><creatorcontrib>Colombel, Marc</creatorcontrib><creatorcontrib>Crouzet, Sébastien</creatorcontrib><creatorcontrib>Schott, Anne-Marie</creatorcontrib><creatorcontrib>Lemaitre, Laurent</creatorcontrib><creatorcontrib>Rabilloud, Muriel</creatorcontrib><creatorcontrib>Grenier, Nicolas</creatorcontrib><creatorcontrib>Barry Delongchamps, Nicolas</creatorcontrib><creatorcontrib>Boutier, Romain</creatorcontrib><creatorcontrib>Bratan, Flavie</creatorcontrib><creatorcontrib>Brunelle, Serge</creatorcontrib><creatorcontrib>Camparo, Philippe</creatorcontrib><creatorcontrib>Colin, Pierre</creatorcontrib><creatorcontrib>Corréas, Jean-Michel</creatorcontrib><creatorcontrib>Cornélis, François</creatorcontrib><creatorcontrib>Cornud, François</creatorcontrib><creatorcontrib>Cros, Fanny</creatorcontrib><creatorcontrib>Descotes, Jean-Luc</creatorcontrib><creatorcontrib>Eschwege, Pascal</creatorcontrib><creatorcontrib>Fiard, Gaelle</creatorcontrib><creatorcontrib>Fendler, Jean-Philippe</creatorcontrib><creatorcontrib>Habchi, Hocine</creatorcontrib><creatorcontrib>Hallouin, Philippe</creatorcontrib><creatorcontrib>Khairoune, Ahmed</creatorcontrib><creatorcontrib>Lang, Hervé</creatorcontrib><creatorcontrib>Lebras, Yann</creatorcontrib><creatorcontrib>Lefèvre, Frédéric</creatorcontrib><creatorcontrib>Malavaud, Bernard</creatorcontrib><creatorcontrib>Moldovan, Paul Cezar</creatorcontrib><creatorcontrib>Mottet, Nicolas</creatorcontrib><creatorcontrib>Mozer, Pierre</creatorcontrib><creatorcontrib>Nevoux, Pierre</creatorcontrib><creatorcontrib>Pagnoux, Gaele</creatorcontrib><creatorcontrib>Pasticier, Gilles</creatorcontrib><creatorcontrib>Portalez, Daniel</creatorcontrib><creatorcontrib>Potiron, Eric</creatorcontrib><creatorcontrib>Thammavong, Athivada Soto</creatorcontrib><creatorcontrib>Timsit, Marc-Olivier</creatorcontrib><creatorcontrib>Viller, Arnault</creatorcontrib><creatorcontrib>Walz, Jochen</creatorcontrib><creatorcontrib>MRI-FIRST Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest Public Health Database</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 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Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>The lancet oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rouvière, Olivier</au><au>Puech, Philippe</au><au>Renard-Penna, Raphaële</au><au>Claudon, Michel</au><au>Roy, Catherine</au><au>Mège-Lechevallier, Florence</au><au>Decaussin-Petrucci, Myriam</au><au>Dubreuil-Chambardel, Marine</au><au>Magaud, Laurent</au><au>Remontet, Laurent</au><au>Ruffion, Alain</au><au>Colombel, Marc</au><au>Crouzet, Sébastien</au><au>Schott, Anne-Marie</au><au>Lemaitre, Laurent</au><au>Rabilloud, Muriel</au><au>Grenier, Nicolas</au><au>Barry Delongchamps, Nicolas</au><au>Boutier, Romain</au><au>Bratan, Flavie</au><au>Brunelle, Serge</au><au>Camparo, Philippe</au><au>Colin, Pierre</au><au>Corréas, Jean-Michel</au><au>Cornélis, François</au><au>Cornud, François</au><au>Cros, Fanny</au><au>Descotes, Jean-Luc</au><au>Eschwege, Pascal</au><au>Fiard, Gaelle</au><au>Fendler, Jean-Philippe</au><au>Habchi, Hocine</au><au>Hallouin, Philippe</au><au>Khairoune, Ahmed</au><au>Lang, Hervé</au><au>Lebras, Yann</au><au>Lefèvre, Frédéric</au><au>Malavaud, Bernard</au><au>Moldovan, Paul Cezar</au><au>Mottet, Nicolas</au><au>Mozer, Pierre</au><au>Nevoux, Pierre</au><au>Pagnoux, Gaele</au><au>Pasticier, Gilles</au><au>Portalez, Daniel</au><au>Potiron, Eric</au><au>Thammavong, Athivada Soto</au><au>Timsit, Marc-Olivier</au><au>Viller, Arnault</au><au>Walz, Jochen</au><aucorp>MRI-FIRST Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2019-01</date><risdate>2019</risdate><volume>20</volume><issue>1</issue><spage>100</spage><epage>109</epage><pages>100-109</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><abstract>Whether multiparametric MRI improves the detection of clinically significant prostate cancer and avoids the need for systematic biopsy in biopsy-naive patients remains controversial. We aimed to investigate whether using this approach before biopsy would improve detection of clinically significant prostate cancer in biopsy-naive patients.
In this prospective, multicentre, paired diagnostic study, done at 16 centres in France, we enrolled patients aged 18–75 years with prostate-specific antigen concentrations of 20 ng/mL or less, and with stage T2c or lower prostate cancer. Eligible patients had been referred for prostate multiparametric MRI before a first set of prostate biopsies, with a planned interval of less than 3 months between MRI and biopsies. An operator masked to multiparametric MRI results did a systematic biopsy by obtaining 12 systematic cores and up to two cores targeting hypoechoic lesions. In the same patient, another operator targeted up to two lesions seen on MRI with a Likert score of 3 or higher (three cores per lesion) using targeted biopsy based on multiparametric MRI findings. Patients with negative multiparametric MRI (Likert score ≤2) had systematic biopsy only. The primary outcome was the detection of clinically significant prostate cancer of International Society of Urological Pathology grade group 2 or higher (csPCa-A), analysed in all patients who received both systematic and targeted biopsies and whose results from both were available for pathological central review, including patients who had protocol deviations. This study is registered with ClinicalTrials.gov, number NCT02485379, and is closed to new participants.
Between July 15, 2015, and Aug 11, 2016, we enrolled 275 patients. 24 (9%) were excluded from the analysis. 53 (21%) of 251 analysed patients had negative (Likert ≤2) multiparametric MRI. csPCa-A was detected in 94 (37%) of 251 patients. 13 (14%) of these 94 patients were diagnosed by systematic biopsy only, 19 (20%) by targeted biopsy only, and 62 (66%) by both techniques. Detection of csPCa-A by systematic biopsy (29·9%, 95% CI 24·3–36·0) and targeted biopsy (32·3%, 26·5–38·4) did not differ significantly (p=0·38). csPCa-A would have been missed in 5·2% (95% CI 2·8–8·7) of patients had systematic biopsy not been done, and in 7·6% (4·6–11·6) of patients had targeted biopsy not been done. Four grade 3 post-biopsy adverse events were reported (3 cases of prostatitis, and 1 case of urinary retention with haematuria).
There was no difference between systematic biopsy and targeted biopsy in the detection of ISUP grade group 2 or higher prostate cancer; however, this detection was improved by combining both techniques and both techniques showed substantial added value. Thus, obtaining a multiparametric MRI before biopsy in biopsy-naive patients can improve the detection of clinically significant prostate cancer but does not seem to avoid the need for systematic biopsy.
French National Cancer Institute.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30470502</pmid><doi>10.1016/S1470-2045(18)30569-2</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-3337-4474</orcidid><orcidid>https://orcid.org/0000-0003-0898-9557</orcidid><orcidid>https://orcid.org/0000-0003-1324-0356</orcidid><orcidid>https://orcid.org/0000-0003-3393-4216</orcidid><orcidid>https://orcid.org/0000-0002-0030-478X</orcidid><orcidid>https://orcid.org/0000-0003-0512-3459</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2019-01, Vol.20 (1), p.100-109 |
| issn | 1470-2045 1474-5488 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_02180082v1 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adolescent Adult Aged Biopsy Hematuria Humans Image-Guided Biopsy - adverse effects Image-Guided Biopsy - methods Life Sciences Magnetic resonance imaging Male Medical diagnosis Middle Aged Multiparametric Magnetic Resonance Imaging Prospective Studies Prostate - diagnostic imaging Prostate - pathology Prostate cancer Prostate-specific antigen Prostate-Specific Antigen - blood Prostatic Neoplasms - diagnostic imaging Prostatic Neoplasms - pathology Prostatitis Tumors Ultrasonography, Interventional Young Adult |
| title | Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study |
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