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1. Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trialResearch in context

Author

Marc Sapoval, Nicolas Thiounn, Aurélien Descazeaud, Carole Déan, Alain Ruffion, Gaële Pagnoux, Ricardo Codas Duarte, Grégoire Robert, Francois Petitpierre, Gilles Karsenty, Vincent Vidal, Thibaut Murez, Hélène Vernhet-Kovacsik, Alexandre de la Taille, Hicham Kobeiter, Romain Mathieu, Jean-Francois Heautot, Stéphane Droupy, Julien Frandon, Nicolas Barry Delongchamps, Virginie Korb-Savoldelli, Isabelle Durand-Zaleski, Helena Pereira, Gilles Chatellier, Olivier Pellerin, Brigitte Sabatier, Charles Dariane, Benjamin Gabay, Paul Cezar Moldovan, Olivier Rouvière, Jean Champagnac, Samuel Lagabrielle, Nicolas Grenier, Romain Boissier, Éric Lechevallier, Jalal-Jean Izaaryene, Farouk Tradi, Raphaele Arrouasse, Julien Defontaines, Xavier Joseph, Philippe Le Corvoisier, Emilie Sbidian, Cécile Champy, Mélanie Chiaradia, Armand Chevrot, Cyrille Blion, Jean Goupil, Julie Bulsei, and Alexandra Vappereau

Subjects
Lower urinary tract symptoms, Benign prostatic hyperplasia, International prostatic symptom score, Erectile function, Prostatic artery embolisation, Alpha-blockers, Public aspects of medicine, RA1-1270
Abstract

Summary: Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was −10.0 (95% confidence interval [CI]: −11.8 to −8.3) and −5.7 (95% CI: −7.5 to −3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (−4.4 [95% CI: −6.9 to −1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9–13.5) and −2.8 (95% CI: −8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively. Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months. Funding: French Ministry of Health and a complementary grant from Merit Medical.

Published
2023
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2. The current role of prostate multiparametric magnetic resonance imaging

Author

Olivier Rouviere and Paul Cezar Moldovan

Subjects
Diseases of the genitourinary system. Urology, RC870-923
Abstract

Prostate multi-parametric magnetic resonance imaging (mpMRI) has shown excellent sensitivity for Gleason ≥7 cancers, especially when their volume is ≥0.5 mL. As a result, performing an mpMRI before prostate biopsy could improve the detection of clinically significant prostate cancer (csPCa) by adding targeted biopsies to systematic biopsies. Currently, there is a consensus that targeted biopsies improve the detection of csPCa in the repeat biopsy setting and at confirmatory biopsy in patients considering active surveillance. Several prospective multicentric controlled trials recently showed that targeted biopsy also improved csPCa detection in biopsy-naïve patients. The role of mpMRI and targeted biopsy during the follow-up of active surveillance remains unclear. Whether systematic biopsy could be omitted in case of negative mpMRI is also a matter of controversy. mpMRI did show excellent negative predictive values (NPV) in the literature, however, since NPV depends on the prevalence of the disease, negative mpMRI findings should be interpreted in the light of a priori risk for csPCa of the patient. Nomograms combining mpMRI findings and classical risk predictors (age, prostate-specific antigen density, digital rectal examination, etc.) will probably be developed in the future to decide whether a prostate biopsy should be obtained. mpMRI has a good specificity for detecting T3 stage cancers, but its sensitivity is low. It should therefore not be used routinely for staging purposes in low-risk patients. Nomograms combining mpMRI findings and other clinical and biochemical data will also probably be used in the future to better assess the risk of T3 stage disease. Keywords: Prostate cancer, Magnetic resonance imaging, Prostate biopsy, Active surveillance, Nomograms

Published
2019
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3. Combined model-based and deep learning-based automated 3D zonal segmentation of the prostate on T2-weighted MR images: clinical evaluation

Author

Olivier Rouvière, Paul Cezar Moldovan, Anna Vlachomitrou, Sylvain Gouttard, Benjamin Riche, Alexandra Groth, Mark Rabotnikov, Alain Ruffion, Marc Colombel, Sébastien Crouzet, Juergen Weese, Muriel Rabilloud, Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Philips Research [Germany], Philips Research, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Centre pour l'innovation en cancérologie de Lyon (CICLY), Université de Lyon-Université de Lyon, Philips Research Europe - Hamburg, Sector Medical Imaging Systems, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, Deep Learning, [SDV]Life Sciences [q-bio], Image Processing, Computer-Assisted, Prostate, Humans, Radiology, Nuclear Medicine and imaging, General Medicine, Magnetic Resonance Imaging, ComputingMilieux_MISCELLANEOUS, Algorithms, Pelvis
Abstract

To train and to test for prostate zonal segmentation an existing algorithm already trained for whole-gland segmentation.The algorithm, combining model-based and deep learning-based approaches, was trained for zonal segmentation using the NCI-ISBI-2013 dataset and 70 T2-weighted datasets acquired at an academic centre. Test datasets were randomly selected among examinations performed at this centre on one of two scanners (General Electric, 1.5 T; Philips, 3 T) not used for training. Automated segmentations were corrected by two independent radiologists. When segmentation was initiated outside the prostate, images were cropped and segmentation repeated. Factors influencing the algorithm's mean Dice similarity coefficient (DSC) and its precision were assessed using beta regression.Eighty-two test datasets were selected; one was excluded. In 13/81 datasets, segmentation started outside the prostate, but zonal segmentation was possible after image cropping. Depending on the radiologist chosen as reference, algorithm's median DSCs were 96.4/97.4%, 91.8/93.0% and 79.9/89.6% for whole-gland, central gland and anterior fibromuscular stroma (AFMS) segmentations, respectively. DSCs comparing radiologists' delineations were 95.8%, 93.6% and 81.7%, respectively. For all segmentation tasks, the scanner used for imaging significantly influenced the mean DSC and its precision, and the mean DSC was significantly lower in cases with initial segmentation outside the prostate. For central gland segmentation, the mean DSC was also significantly lower in larger prostates. The radiologist chosen as reference had no significant impact, except for AFMS segmentation.The algorithm performance fell within the range of inter-reader variability but remained significantly impacted by the scanner used for imaging.• Median Dice similarity coefficients obtained by the algorithm fell within human inter-reader variability for the three segmentation tasks (whole gland, central gland, anterior fibromuscular stroma). • The scanner used for imaging significantly impacted the performance of the automated segmentation for the three segmentation tasks. • The performance of the automated segmentation of the anterior fibromuscular stroma was highly variable across patients and showed also high variability across the two radiologists.

Published
2022

4. Prostatic arterial embolization versus holmium laser enucleation of the prostate: 1-year outcomes

Author

Emilien Seizilles de Mazancourt, Gaelle Pagnoux, Ricardo Codas Duarte, Paul Cezar Moldovan, Alain Ruffion, Marc Colombel, Lionel Badet, and Hakim Fassi-Fehri

Subjects
Urology
Abstract

Holmium Laser Enucleation of the Prostate (HoLEP) and Prostatic Artery Embolization (PAE) are novel techniques for the treatment of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS). The objective of this study was to describe and compare the functional results and complications of these two techniques at one year follow-up.We performed a retrospective, monocentric study of all patients consecutively treated in our center with HoLEP or PAE for symptomatic or complicated BPH between January 2016 and December 2019. Data regarding patient and perioperative characteristics, follow-up biological results, functional questionnaires and uroflowmetry were collected from medical records.A total of 490 and 57 patients were treated with HoLEP and PAE, respectively. The demographic and clinical characteristics of the two groups were similar. The operative time was significantly higher for PAE (p 0.001) and hospitalization time longer after HoLEP (p = 0.0006). The urinary catheterization time was longer after PAE (p 0.001). The prostatic volume treated was higher with HoLEP than with PAE (56% versus 26%, p 0.001). The mean difference in IPSS from baseline to 12 months was significantly higher after HoLEP than after PAE: - 17.58 versus - 8 (p 0.001). The mean difference in QoL-IPSS from baseline to 12 months was significantly higher after HoLEP: - 4.09 versus - 2.27 (p 0.001). The rate of postoperative adverse events in the first three months was similar between the two groups:35% after HoLEP and 33% after PAE (p = 0.88).HoLEP and PAE both significantly improved BPH-LUTS, with HoLEP having an advantage over PAE.

Published
2022

5. 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

Author

Athivada Soto Thammavong, Raphaële Renard-Penna, Gilles Pasticier, Jean-Philippe Fendler, Flavie Bratan, Romain Boutier, Hervé Lang, Pascal Eschwege, Jochen Walz, Arnault Viller, Myriam Decaussin-Petrucci, Alain Ruffion, Nicolas Barry Delongchamps, Y. Lebras, François Cornud, Pierre Mozer, Jean-Michel Correas, Olivier Rouvière, Laurent Lemaitre, Michel Claudon, Paul C. Moldovan, Marine Dubreuil-Chambardel, Fanny Cros, Pierre Colin, Bernard Malavaud, Sebastien Crouzet, Hocine Habchi, Ahmed Khairoune, F Lefèvre, Anne-Marie Schott, Nicolas Grenier, G. Pagnoux, S. Brunelle, Marc Colombel, Laurent Magaud, Laurent Remontet, Philippe Camparo, Philippe Puech, François Cornelis, Florence Mège-Lechevallier, Muriel Rabilloud, Pierre Nevoux, E. Potiron, Daniel Portalez, Marc-Olivier Timsit, Nicolas Mottet, Gaelle Fiard, Jean-Luc Descotes, Catherine Roy, Philippe Hallouin, Hospices Civils de Lyon (HCL), Therapies Interventionnelles Assistees Par l'Image et la Simulation, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 (ONCO-THAI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université de Lille, Service d'urologie et transplantation rénales [CHU Pitié-Salpétrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département de Radiologie adultes [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Université de Lorraine (UL), Imagerie Adaptative Diagnostique et Interventionnelle (IADI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), CHU Strasbourg, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Service de Biostatistiques [Lyon], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Hôpital Edouard Herriot [CHU - HCL], Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon], Centre Léon Bérard [Lyon], Service d'urologie [Centre Hospitalier Lyon Sud - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Centre de recherche cerveau et cognition (CERCO), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS)-Institut des sciences du cerveau de Toulouse. (ISCT), Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Toulouse - Jean Jaurès (UT2J)-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Biostatistiques santé, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Imagerie moléculaire et fonctionnelle: de la physiologie à la thérapie, Université Bordeaux Segalen - Bordeaux 2-IFR8-Centre National de la Recherche Scientifique (CNRS), Centre de Recherches en Cancérologie de Toulouse (CRCT), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de Lyon, Departement de Neurologie (HCL), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), CHU Amiens-Picardie, Service de radiologie [CHU Necker], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Bordeaux (UB), Service Maladies infectieuses et tropicales [AP-HP Hôpital Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Gestes Medico-chirurgicaux Assistés par Ordinateur (TIMC-IMAG-GMCAO), Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Centre Hospitalier Universitaire [Grenoble] (CHU), Service d'Urologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre hospitalier Saint Joseph - Saint Luc [Lyon], Centre Hospitalier Universitaire de Reims (CHU Reims), CHU Necker - Enfants Malades [AP-HP], Service d'urologie [Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Bordeaux [Bordeaux], Centre d'Energétique et de Thermique de Lyon (CETHIL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'urologie, andrologie et transplantation rénale, Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Service d'Hématologie [IUCT Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Lille 2 - Faculté de Médecine, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université Paris Descartes - Paris 5 (UPD5), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Therapies Interventionnelles Assistees Par l'Image et la Simulation - U 703 (Thiais), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut des sciences du cerveau de Toulouse. (ISCT), Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), MRI-FIRST Investigators: Nicolas Barry Delongchamps, Romain Boutier, Flavie Bratan, Serge Brunelle, Philippe Camparo, Pierre Colin, Jean-Michel Corréas, François Cornélis, François Cornud, Fanny Cros, Jean-Luc Descotes, Pascal Eschwege, Gaelle Fiard, Jean-Philippe Fendler, Hocine Habchi, Philippe Hallouin, Ahmed Khairoune, Hervé Lang, Yann Lebras, Frédéric Lefèvre, Bernard Malavaud, Paul Cezar Moldovan, Nicolas Mottet, Pierre Mozer, Pierre Nevoux, Gaele Pagnoux, Gilles Pasticier, Daniel Portalez, Eric Potiron, Athivada Soto Thammavong, Marc-Olivier Timsit, Arnault Viller, Jochen Walz, Thérapies Laser Assistées par l'Image pour l'Oncologie (ONCO-THAI), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Université de Lorraine (UL), Centre de Recherche en Cancérologie de Lyon (CRCL), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Service d'Urologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), and CCSD, Accord Elsevier

Subjects
Adult, Image-Guided Biopsy, Male, medicine.medical_specialty, Adolescent, [SDV]Life Sciences [q-bio], 030232 urology & nephrology, Prostatitis, Young Adult, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Prostate, Biopsy, medicine, Humans, Prospective Studies, Multiparametric Magnetic Resonance Imaging, Stage (cooking), Prospective cohort study, Ultrasonography, Interventional, Aged, medicine.diagnostic_test, Urinary retention, business.industry, Prostatic Neoplasms, Cancer, Middle Aged, Prostate-Specific Antigen, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, Radiology, medicine.symptom, business
Abstract

Summary 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. Funding French National Cancer Institute.

Published
2019

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