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 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.

The Lancet. Oncology. 2018 Nov 21 [Epub]

Olivier Rouvière, Philippe Puech, Raphaële Renard-Penna, Michel Claudon, Catherine Roy, Florence Mège-Lechevallier, Myriam Decaussin-Petrucci, Marine Dubreuil-Chambardel, Laurent Magaud, Laurent Remontet, Alain Ruffion, Marc Colombel, Sébastien Crouzet, Anne-Marie Schott, Laurent Lemaitre, Muriel Rabilloud, Nicolas Grenier, MRI-FIRST Investigators

Service d'Imagerie Urinaire et Vasculaire, Hospices Civils de Lyon, Lyon, France; Faculté de Médecine Lyon Est, Lyon, France. Electronic address: ., Service de Radiologie, CHU Lille, INSERM, Université de Lille, Lille, France; U1189 - ONCO-THAI - Image Assisted Laser Therapy for Oncology, Lille, France., Services de Radiologie, Hôpitaux Tenon et Pitié Salpétrière, AP-HP, GRC-UPMC n°5 Oncotype-URO, Sorbonne Universités, Paris, France., IADI, INSERM, Université de Lorraine, Nancy, France; Service de Radiologie, CHRU Nancy, Nancy, France., CHU de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France., Service d'Anatomo-Pathologie, Hospices Civils de Lyon, Lyon, France., Service d'Anatomo-Pathologie, Hospices Civils de Lyon, Lyon, France; Faculté de Médecine Lyon Sud, Lyon, France., Service d'Imagerie Urinaire et Vasculaire, Hospices Civils de Lyon, Lyon, France., Center Hospitalier Lyon Sud, Pôle de Santé Publique, Hospices Civils de Lyon, Lyon, France; Health Services and Performance Research, EA 7425 HESPER, Université de Lyon, Lyon, France., Service de Biostatistique et Bioinformatique, Hospices Civils de Lyon, Lyon, France; Université Lyon 1, Université de Lyon, Lyon, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France., Hôpital Edouard Herriot, Service d'Urologie, Hospices Civils de Lyon, Lyon, France; Centre de Recherche en Cancérologie de Lyon - INSERM 1052 CNRS 5286, Centre Léon Bérard, Université Lyon 1, Lyon, France., Service d'Urologie, Hospices Civils de Lyon, Lyon, France; Faculté de Médecine Lyon Est, Lyon, France., Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte, CHU de Bordeaux, Université de Bordeaux, France.

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