Archive ouverte HAL - 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

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 23 Jm Corréas 24 François Cornelis 25 François Cornud 26 Fanny Cros 20 Jean-Luc Descotes 27, 28 Pascal Eschwege 29 Gaelle Fiard 27, 28 J.P. Fendler 30 Hocine Habchi 31 Philippe Hallouin Ahmed Khairoune 32 Herve Lang 33 Yann Lebras 34 Frédéric Lefèvre 35 Bernard Malavaud 36 Paul Cezar Moldovan 12 Nicolas Mottet Pierre Mozer 27 Pierre Nevoux Gaele Pagnoux 12 Gilles Pasticier 37 Daniel Portalez 38 Eric Potiron 39 Athivada Soto Thammavong 40 M.O. Timsit 41, 42, 32 Arnault Viller 43 Jochen Walz 21
17 Biostatistiques santé
Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]
27 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 ClinicalTrials.gov, 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.
Type de document :
Article dans une revue
Liste complète des métadonnées

https://hal.archives-ouvertes.fr/hal-02180082
Contributeur : Catherine Zoppis <>
Soumis le : lundi 5 août 2019 - 15:30:49
Dernière modification le : mercredi 4 septembre 2019 - 13:52:08

Identifiants

Citation

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. The Lancet Oncology, 2019, 20 (1), pp.100-109. ⟨10.1016/S1470-2045(18)30569-2⟩. ⟨hal-02180082⟩

Partager

Métriques

Consultations de la notice

58