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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

Olivier Rouvière 1 Philippe Puech 2, 3, 4 Raphaele Renard-Penna 5 Michel Claudon 6, 7 Catherine Roy 8 Florence Mège-Lechevallier 1 Myriam Decaussin-Petrucci 9 Marine Dubreuil-Chambardel 1 Laurent Magaud 9 Laurent Remontet 10, 11 Alain Ruffion 12, 13, 14 Marc Colombel 15 Sébastien Crouzet 16 Anne-Marie Schott 9 Laurent Lemaître 4, 3 Muriel Rabilloud 17 Nicolas Grenier 18 Nicolas Barry Delongchamps 19 Romain Boutier 20 Flavie Bratan 14 Serge Brunelle 21 Philippe Camparo 22 Pierre Colin Jm Corréas 23 François Cornelis 24 François Cornud 25 Fanny Cros 20 Jean-Luc Descotes 26, 27 Pascal Eschwege 28 Gaelle Fiard 26, 27 J.P. Fendler 29 Hocine Habchi 30 Philippe Hallouin Ahmed Khairoune 31 Herve Lang 32 Yann Lebras 33 Frédéric Lefèvre 34 Bernard Malavaud 35 Paul Cezar Moldovan 12 Nicolas Mottet Pierre Mozer 26 Pierre Nevoux Gaele Pagnoux 12 Gilles Pasticier 36 Daniel Portalez 37 Eric Potiron 38 Athivada Soto Thammavong 39 M.O. Timsit 40, 41, 31 Arnault Viller 42 Jochen Walz 21
17 Biostatistiques santé
Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]
26 TIMC-IMAG-GMCAO - Gestes Medico-chirurgicaux Assistés par Ordinateur
TIMC-IMAG - Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525
Abstract : BACKGROUND: 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. METHODS: 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, number NCT02485379, and is closed to new participants. FINDINGS: 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). INTERPRETATION: 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.
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Contributeur : Catherine Zoppis <>
Soumis le : lundi 5 août 2019 - 15:30:49
Dernière modification le : lundi 10 février 2020 - 16:36:57



Olivier Rouvière, Philippe Puech, Raphaele Renard-Penna, Michel Claudon, Catherine Roy, et al.. 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. Lancet Oncology, Elsevier, 2019, 20 (1), pp.100-109. ⟨10.1016/S1470-2045(18)30569-2⟩. ⟨hal-02180082⟩



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