Bergh, R.C.N. (Roderick) van den

Briers, E. (Erik)

Cornford, P. (Philip)

Cumberbatch, M.G. (Marcus G.)

Fanti, S. (Stefano)

Fossati, N. (Nicola)

Gandaglia, G. (Giorgio)

Grivas, N. (Nikolaos)

Grummet, J. (Jeremy)

Kwast, Th.H. (Theo) van der

Lam, T.B. (Thomas B.)

Lardas, M. (Michael)

Liew, M. (Matthew)

Mason, M.D. (Malcolm)

Moris, L. (Lisa)

Mottet, N. (Nicolas)

Oprea-Lager, D.E. (Daniela E.)

Ploussard, G. (Guillaume)

Poel, H.G. (Henk) van der

Rouvière, O. (Olivier)

Santis, M. (Maria) de

Schoots, I.G. (Ivo)

Tilki, D. (Derya)

van den Broeck, T. (Thomas)

Wiegel, T. (Thomas)

Willemse, P.-P.M. (Peter-Paul M.)

Erasmus University Digital Repository

EURURO-8916; No. of Pages 4Platinum Priority – EditorialReferring to the article published on pp. x–y of this issueE U R O P E A N U R O L O G Y X X X ( 2 0 1 9 ) X X X – X X Xava i lable at www.sc iencedirect .comjourna l homepage: www.europea nurology.comRe: Andrew Vickers, Sigrid V. Carlsson, MatthewCooperberg. Routine Use of Magnetic ResonanceImaging for Early Detection of Prostate Cancer Is NotJustified by the Clinical Trial Evidence. Eur Urol. Inpress. https://doi.org/10.1016/j.eururo.2020.04.016Prebiopsy MRI: Through the Looking GlassA diagnostic test can be defined as any test used to determinethe presence, nature, or severity of a particular condition. Inour technology-driven era, we may like to believe that thebest diagnostic test is the one that provides the most detailswith the highest accuracy for the condition being investigat-ed. However, the most sophisticated and precise test isuseless if its results do not change patient management orimprove relevant outcomes. In other words, it is thephysician’s responsibility to define the right level of detailof the diagnostic test, beyond which further magnificationdoes not result in additional clinical consequences. Thisdilemma applies to many diagnostic tests used in urologicalpractice (Does ultrasensitive prostate-specific antigen [PSA]detect relevant biochemical recurrence? Does novel imagingdetect relevant metastasis?). It also applies to developmentsin prostate biopsy indication and procedure. Is the develop-ment aimed at providing the most accurate representation ofthe tissue of the whole gland, and particularly of the differentprostate cancer (PCa) foci that may be present? Or is it (only)aimed at retrieving the necessary information to adequatelyrisk stratify a patient for clinical decision-making?In their Platinum Opinion paper, Vickers et al [1] arguethat routinely performing magnetic resonance imaging(MRI) before a first set of prostate biopsies is not justified,which is in contradiction to clinical practice guidelines thatnow recommend using MRI in this setting on the basis oflevel 1 evidence [2]. Two main arguments against the use ofMRI are provided: systematic biopsy (SB) provides sufficientdetection of clinically significant PCa (csPCa), and the use ofMRI lesion–targeted biopsy (TB) induces a grade migrationthat may lead to overtreatment. Does our new looking glassmostly cause tunnel vision?DOI of original article: https://doi.org/10.1016/j.eururo.2020.04.016.Please cite this article in press as: van den Bergh RCN, et al. Re: AndUse of Magnetic Resonance Imaging for Early Detection of ProstateIn press. https://doi.org/10.1016/j.eururo.2020.04.016. Eur Urol (2https://doi.org/10.1016/j.eururo.2020.06.0050302-2838/© 2020 Published by Elsevier B.V. on behalf of European AssociaFirst, although SB maintains added value in the popula-tion of biopsy-naïve patients [3–5], it seems difficult tobelieve that it provides adequate detection of csPCa. In theDanish cohort cited by Vickers et al, among patients withnegative SB, the true 20-yr PCa-specific mortality at 20 yrwas 5.2% [6]. The rate of 0.7% cited must be interpreted withcaution, as these data only relate to a subgroup of patientswith PSA < 10 ng/mL, and PSA measurements at diagnosiswere available for only 22% of the cohort. In the Göteborgscreening trial, for men with negative SB in the firstscreening round and PSA levels of 3–10 ng/ml the 20-yrcumulative PCa mortality was 0.6%; for those with PSA> 10 ng/mL the PCa mortality was 21.4% [7]. Metastasis andPCa mortality do occur after negative SB and an imperfectdiagnostic strategy may be a cause.Second, there is no doubt that use of MRI and TBincreases the detection of grade group 2 cancers [3–5,8,9]. We agree with Vickers et al that the use of a moresensitive test may induce stage/grade migration due to theWill Rogers effect (Fig. 1). A grade group 2 cancer onlydetected at TB is on average a different tumour to a gradegroup 2 lesion already found at SB; it is likely to be onaverage smaller (and if risk is a combination of grade andtumour size, also of lower risk). Notably, stage/grademigration constantly occurred during the last 50 yr as thebiopsy indication and technique evolved from digital rectalexamination–guided biopsy to PSA-based transrectal ultra-sound (TRUS)-guided six-core (sextant) lateralised biopsy,to TRUS-guided 12-core (or more) biopsy. The 2005 Inter-national Society of Urological Pathology (ISUP) reclassifica-tion of the Gleason grading system into grade groups led toanother grade migration.But a stage/grade shift is not a reason to abandon the MRIlooking glass and stick to blind sampling of the gland,because it does not rule out the chance that additional csPCawill also be detected after MRI and TB. Not all grade group2 cancers detected by MRI/TB and missed by SB areinsignificant cancers. Improved prostate mapping usingMRI and TB, by providing a more sensitive test for ISUP score(one of the most robust predictors of clinical outcomes), isrew Vickers, Sigrid V. Carlsson, Matthew Cooperberg. Routine Cancer Is Not Justified by the Clinical Trial Evidence. Eur Urol.020), https://doi.org/10.1016/j.eururo.2020.06.005tion of Urology.Fig. 1 – Schematic representation of different scenarios for a newdiagnostic test versus a reference test. The low-risk group is consideredfor expectant management, while high-risk cases are considered fortreatment. Reference test: established risk groups represent thesignificance of the disease. Insignificant cases are overdetected andsignificant cases are underdetected. Scenario A for the new test: stageshift only for the risk groups with no difference in the significance ofthe disease and a risk of overtreatment. Scenario B for the new test: nodetection of insignificant disease and detection of only significantdisease, which represents a perfect test. Scenario C for the new test:combined effect, with a lower rate of testing, a reduction inoverdetection of insignificant disease, and improved detection ofsignificant disease.E U R O P E A N U R O L O G Y X X X ( 2 0 1 9 ) X X X – X X X2EURURO-8916; No. of Pages 4likely to provide additional parameters and allow furtherrefinement of current risk groups using clinical outcomes ofMRI-based diagnosed PCa [10].While waiting for data for patients with TB-diagnosedPCa to mature, we believe that rather than rejecting MRI forbiopsy-naïve patients, the urological community shouldadopt a pragmatic approach by mitigating the potentialconsequences of stage/grade migration. Thus, recognisingthat improved targeting could artificially inflate the ISUPgrade of the tumours by focusing the sampling at areas ofhigh-grade cancer, a recent ISUP consensus conference hasalready suggested the use of an aggregated ISUP gradesummarising the results of all the targeted biopsy coresrather than the worst core from the same MRI-identifiedlesion [11]. In addition, results from TB should also not beinterpreted as stand-alone but in the light of the clinicalcontext, MRI parameters such as the apparent diffusioncoefficient and tumour size, PSA density, and SB results. As aresult, a greater proportion of grade group 2 cancers maybecome eligible for active surveillance [12].An essential point not addressed by Vickers et al is thatconcordant studies suggest that a biopsy indication strategycombining high-quality MRI and clinical and biochemicaldata (such as PSA density) improves the selection forPlease cite this article in press as: van den Bergh RCN, et al. Re: AndUse of Magnetic Resonance Imaging for Early Detection of ProstateIn press. https://doi.org/10.1016/j.eururo.2020.04.016. Eur Urol (2prostate biopsy [2]. TB has the potential to dramaticallydecrease the number of unnecessary biopsies and resultingpostbiopsy complications. Although SB is currently stillrecommended in addition to TB, the strategy has thepotential to also reduce diagnosis of grade group 1 cancers[2].In conclusion, there is clear evidence that MRI and TBimprove the detection of grade group 2 cancer over SB.This higher rate should be interpreted with care. Somedetected cancers may correspond to small cancers as aresult of stage/grade migration, while others may beaggressive tumours that would otherwise have beenmissed. The urological community should adapt riskclassification in order to correctly separate the wheat fromthe chaff in the MRI era. Importantly, growing evidencesuggests that MRI, in combination with clinical data, couldalso help in selecting patients with very low-risk cancerwho do not need to undergo biopsy at all. The advantages ofusing prebiopsy MRI clearly outweigh the suggested harms.Appendix A. Members of the EAU-EANM-ESTRO-ESUR-SIOG Prostate Cancer Guidelines Panel who contributedto group authorship of this letterErik Briers, Hasselt, BelgiumThomas Van den Broeck, Department of Urology,University Hospitals Leuven, and Laboratory of MolecularEndocrinology, KU Leuven, Leuven, BelgiumPhilip Cornford, Royal Liverpool and Broadgreen Hospi-tals NHS Trust, Liverpool, UKMarcus G. Cumberbatch, Academic Urology Unit, Uni-versity of Sheffield, Sheffield, UKMaria De Santis, Charite Universitätsmedizin, Berlin,Germany, and Department of Urology, Medical University ofVienna, Vienna, AustriaStefano Fanti, Department of Nuclear Medicine, Policli-nico S. Orsola, University of Bologna, Bologna, ItalyNicola Fossati, Unit of Urology/Division of Oncology,Urological Research Institute, IRCCS Ospedale San Raffaele,and Università Vita-Salute San Raffaele, Milan, ItalyGiorgio Gandaglia, Unit of Urology/Division of Oncology,Urological Research Institute, IRCCS Ospedale San Raffaele,and Università Vita-Salute San Raffaele, Milan, ItalyNikolaos Grivas, Department of Urology, NetherlandsCancer Institute, Amsterdam, The NetherlandsJeremy Grummet, Department of Surgery, Central Clini-cal School, Monash University, Caulfield North, Victoria,AustraliaThomas B. Lam, Academic Urology Unit, University ofAberdeen, and Department of Urology, Aberdeen RoyalInfirmary, Aberdeen, UKMichael Lardas, Department of Urology, Leto Hospital,Athens, GreeceMatthew Liew, Department of Urology, Wrightington,Wigan and Leigh NHS Foundation Trust, Wigan, UKLisa Moris, Department of Urology, University HospitalsLeuven, and Laboratory of Molecular Endocrinology, KULeuven, Leuven, Belgiumrew Vickers, Sigrid V. Carlsson, Matthew Cooperberg. Routine Cancer Is Not Justified by the Clinical Trial Evidence. Eur Urol.020), https://doi.org/10.1016/j.eururo.2020.06.005E U R O P E A N U R O L O G Y X X X ( 2 0 1 9 ) X X X – X X X 3EURURO-8916; No. of Pages 4Malcolm D. Mason, Division of Cancer & Genetics, Schoolof Medicine Cardiff University, Velindre Cancer Centre,Cardiff, UKNicolas Mottet, Department of Urology, UniversityHospital, St. Etienne, FranceDaniela E. Oprea-Lager, Department of Radiology &Nuclear Medicine, Amsterdam University Medical Centers,VU University Medical Center, Amsterdam, The NetherlandsGuillaume Ploussard, Department of Urology, Clinique LaCroix du Sud-St. Jean Languedoc, and Institut Universitairedu Cancer, Toulouse, FranceIvo G. Schoots, Department of Radiology & NuclearMedicine, Amsterdam University Medical Centers, VUUniversity Medical Center, Amsterdam, The NetherlandsDerya Tilki, Martini-Klinik Prostate Cancer Center andDepartment of Urology, University Hospital Hamburg-Eppendorf, Hamburg, GermanyHenk G. van der Poel, Department of Urology,Netherlands Cancer Institute, Amsterdam, The NetherlandsThomas Wiegel, Department of Radiation Oncology,University Hospital Ulm, Ulm, GermanyPeter-Paul M. Willemse, Department of Urology, Univer-sity Hospital Groningen, Groningen, The NetherlandsConflicts of interest: Erik Briers has received grant and research supportfrom IPSEN and the European Association of Urology, and Bayer; is an exofficio board member for Europa UOMO; is an ethics committee andadvisory group member for REQUITE; is a patient advisory boardmember for PAGMI; and is a member of SCA and EMA PCWP. PhilipCornford is a company consultant for Astellas, Ipsen, and Ferring; hasreceived company speaker honoraria from Astellas, Janssen, Ipsen, andPfizer; has participated in trials run by Ferring; and has receivedfellowships and travel grants from Astellas and Janssen. Maria De Santisis a company consultant for Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Dendreon, Eisai Inc., ESSA, Ferring, GSK, Incyte,IPSEN, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre FabreOncologie, Roche, Sanofi Aventis, SeaGen, Shionogi, Synthon, Takeda,Teva, OncoGenex, and Sandoz; receives speaker honoraria from Amgen,Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Ferring, GSK, IPSEN,Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie,Roche, Sanofi Aventis, Synthon, and Takeda; participates in trials run byTechnical University Munich, Amgen, Astellas, AstraZeneca, Bayer,Bristol-Myers Squibb, Celgene, Dendreon, Eisai Inc., Ferring, GSK, IPSEN,Incyte, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre FabreOncologie, Roche, Sanofi Aventis, SOTIO, and Cancer Research UK; andas a member of the EORTC GU group participates in various trials. She hasreceived research grants from Pierre Fabre Oncologie and travel grantsfrom Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene,Dendreaon, Ferring, GSK, IPSEN, Incyte, Janssen Cilag, Merck, MSD,Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, SeaGen,Shionogi, Synthon, Takeda, and Teva/OncoGenex. Stefano Fanti is acompany consultant for Bayer and ANMI; has received speaker honorariafrom Bayer, Genzyme, ANMI, and GE Healthcare; and participates intrials by Amgen, Bayer, BMS, Genzyme, Janssen, Merck, and Novartis.Jeremy Grummet has received a speaker honorarium from Mundi-pharma, a travel grant from Astellas, and a research grant from CancerAustralia. He is the owner of MRI PRO Pty Ltd., an online trainingplatform. Thomas B. Lam is a company consultant for and has receivedcompany speaker honoraria from Pfizer, GSK, Astellas, and IPSEN.Malcolm D. Mason is a company consultant for Ellipses Pharma andPlease cite this article in press as: van den Bergh RCN, et al. Re: AndUse of Magnetic Resonance Imaging for Early Detection of ProstateIn press. https://doi.org/10.1016/j.eururo.2020.04.016. Eur Urol (2Oncotherics. Nicolas Mottet is a company consultant for Janssen, GE,BMS, Sanofi, and Astellas; has received speaker honoraria from Astellas,Pierre Fabre, Steba, Janssen, and Ferring; and has received fellowshipsand travel grants from Astellas, Ipsen, Sanofi, Janssen, and Roche. DeryaTilki has received a speaker honorarium from Astellas and a travel grantfrom Janssen. Henk G. van der Poel is a company consultant for IntuitiveSurgical; has participated in trials for Astellas and Steba Biotech; and hasreceived grant and research support from Astellas. Thomas Wiegel is anadvisory board member for IPSEN; receives company speaker honorariafrom IPSEN and Hexal; is a member of the Janssen Steering Committee;and has participated in the ATLAS/AUO trial. The remaining authors havenothing to disclose.’References[1] Vickers A, Carlsson SV, Cooperberg M. Routine use of magneticresonance imaging for early detection of prostate cancer is notjustified by the clinical trial evidence. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.04.016.[2] Mottet N, Cornford P, van den Bergh RCN, et al. EAU-EANM-ESTRO-ESUR-SIOG guidelines on prostate cancer. Arnhem,The Netherlands: European Association of Urology; 2020.[3] Drost FH, Osses DF, Nieboer D, et al. Prostate MRI, with or withoutMRI-targeted biopsy, and systematic biopsy for detecting prostatecancer. Cochrane Database Syst Rev 2019;2019:CD012663.[4] Rouviere O, Puech P, Renard-Penna R, et al. Use of prostate system-atic and targeted biopsy on the basis of multiparametric MRI inbiopsy-naive patients (MRI-FIRST): a prospective, multicentre,paired diagnostic study. Lancet Oncol 2019;20:100–9.[5] van der Leest M, Cornel E, Israel B, et al. Head-to-head comparisonof transrectal ultrasound-guided prostate biopsy versus multipara-metric prostate resonance imaging with subsequent magnetic res-onance-guided biopsy in biopsy-naive men with elevated prostate-specific antigen: a large prospective multicenter clinical study. EurUrol 2019;75:570–8.[6] Klemann N, Roder MA, Helgstrand JT, et al. Risk of prostate cancerdiagnosis and mortality in men with a benign initial transrectalultrasound-guided biopsy set: a population-based study. LancetOncol 2017;18:221–9.[7] Palmstedt E, Mansson M, Franlund M, et al. Long-term outcomes formen in a prostate screening trial with an initial benign prostatebiopsy: a population-based cohort. Eur Urol Oncol 2019;2:716–22.[8] Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracyof multi-parametric MRI and TRUS biopsy in prostate cancer(PROMIS): a paired validating confirmatory study. Lancet2017;389:815–22.[9] Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-targeted orstandard biopsy for prostate-cancer diagnosis. N Engl J Med2018;378:1767–77.[10] Ploussard G, Manceau C, Beauval JB, et al. Decreased accuracy of theprostate cancer EAU risk group classification in the era of imaging-guided diagnostic pathway: proposal for a new classification basedon MRI-targeted biopsies and early oncologic outcomes aftersurgery. World J Urol. In press. https://doi.org/10.1007/s00345-019-03053-6.[11] Van Leenders GJ, Van der Kwast T, Grignon D, et al. The 2019 Inter-national Society of Urological Pathology (ISUP) Consensus Confer-ence on Grading of Prostatic Carcinoma. Am J Surg Pathol. In press.[12] Ploussard G, Beauval JB, Lesourd M, et al. Active surveillance eligi-bility of MRI-positive patients with grade group 2 prostate cancer: apathological study. World J Urol. In press. https://doi.org/10.1007/s00345-019-02973-7.rew Vickers, Sigrid V. Carlsson, Matthew Cooperberg. Routine Cancer Is Not Justified by the Clinical Trial Evidence. Eur Urol.020), https://doi.org/10.1016/j.eururo.2020.06.005E U R O P E A N U R O L O G Y X X X ( 2 0 1 9 ) X X X – X X X4EURURO-8916; No. of Pages 4Roderick C.N. van den Bergha,*Olivier RouvièrebcTheodorus van der Kwastdon behalf of the EAU-EANM-ESTRO-ESUR-SIOG Prostate CancerGuidelines PanelyaDepartment of Urology, St. Antonius Hospital, Utrecht, The NetherlandsbHospices Civils de Lyon, Department of Urinary and Vascular Imaging,Hôpital Edouard Herriot, Lyon, FrancecUniversité de Lyon, Université Lyon 1, Faculté de Médecine Lyon Est, Lyon,FrancedDepartment of Pathology, Erasmus University Medical Center, Rotterdam,The NetherlandsPlease cite this article in press as: van den Bergh RCN, et al. Re: AndUse of Magnetic Resonance Imaging for Early Detection of ProstateIn press. https://doi.org/10.1016/j.eururo.2020.04.016. Eur Urol (2*Corresponding author. Department of Urology, St. Antonius Hospital,Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.Tel. +31 623 456800, Fax: +31 88 3203000.E-mail addresses: roodvdb@hotmail.com (R.C. van den Bergh).r.van.den.bergh@antoniusziekenhuis.nl (R.C. van den Bergh).yMembers of the EAU-EANM-ESTRO-ESUR-SIOG Prostate CancerGuidelines Panel who contributed to group authorship of this letter arelisted in Appendix A.June 4, 2020rew Vickers, Sigrid V. Carlsson, Matthew Cooperberg. Routine Cancer Is Not Justified by the Clinical Trial Evidence. Eur Urol.020), https://doi.org/10.1016/j.eururo.2020.06.005

Re: Andrew Vickers, Sigrid V. Carlsson, Matthew Cooperberg. Routine Use of Magnetic Resonance Imaging for Early Detection of Prostate Cancer Is Not Justified by the Clinical Trial Evidence. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.04.016: Prebiopsy MRI: Through the Looking Glass

https://repub.eur.nl/pub/129191/Repub_129191.pdf

Re: Andrew Vickers, Sigrid V. Carlsson, Matthew Cooperberg. Routine Use of Magnetic Resonance Imaging for Early Detection of Prostate Cancer Is Not Justified by the Clinical Trial Evidence. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.04.016: Prebiopsy MRI: Through the Looking Glass

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