Negative Prebiopsy Magnetic Resonance Imaging and Risk of Significant Prostate Cancer: Baseline and Long-Term Followup Results

No AccessJournal of UrologyAdult Urology1 Mar 2021Negative Prebiopsy Magnetic Resonance Imaging and Risk of Significant Prostate Cancer: Baseline and Long-Term Followup Results Julie Buisset, Joseph M. Norris, Philippe Puech, Xavier Leroy, Nassima Ramdane, Elodie Drumez, Arnauld Villers, and Jonathan Olivier Julie BuissetJulie Buisset Department of Urology, Univ. Lille, Lille, France , Joseph M. NorrisJoseph M. Norris Division of Surgery and Interventional Science, University College London, London, UK , Philippe PuechPhilippe Puech Department of Radiology, Univ. Lille, Lille, France , Xavier LeroyXavier Leroy Department of Histopathology, Univ. Lille, Lille, France , Nassima RamdaneNassima Ramdane CHU Lille, Department of Biostatistics, Lille, France Univ. Lille, CHU Lille, ULR 2694—METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, Lille, France , Elodie DrumezElodie Drumez CHU Lille, Department of Biostatistics, Lille, France Univ. Lille, CHU Lille, ULR 2694—METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, Lille, France , Arnauld VillersArnauld Villers Department of Urology, Univ. Lille, Lille, France UMR8161/CNRS-Institut de Biologie de Lille, Lille, France , and Jonathan OlivierJonathan Olivier *Correspondence: Service d'Urologie, Hôpital Claude Huriez, Rue Michel Polonowski, 59037Lille, France [telephone: +33(0)674249071; E-mail Address: [email protected] Department of Urology, Univ. Lille, Lille, France UMR8161/CNRS-Institut de Biologie de Lille, Lille, France View All Author Informationhttps://doi.org/10.1097/JU.0000000000001414AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Prostate biopsy should be discussed with the patient in cases of negative magnetic resonance imaging and low clinical suspicion of prostate cancer.Our primary objective was to describe the risk of clinically significant prostate cancer in a negative magnetic resonance imaging biopsy naïve population at baseline and during long-term followup. The secondary objective was to evaluate clinical factors and prostate specific antigen as predictors of clinically significant prostate cancer at baseline. Materials and Methods: All 503 consecutive patients who were biopsy naïve referred from 2007 to 2017 for biopsy with negative magnetic resonance imaging (PI-RADS™ 1–2) who had systematic 12-core biopsies at baseline were included. Clinical factors were digital rectal examination, prostate cancer family history and prostate specific antigen. In case of suspicious digital rectal examination or prostate specific antigen kinetics during followup, magnetic resonance imaging and biopsy were performed. Clinically significant prostate cancer was defined as either Gleason Grade 1 with cancer core length greater than 5 mm or 3 or more positive systematic 12-core biopsies in addition to Gleason Grade 2 or greater (clinically significant prostate cancer-1) or any Gleason Grade 2 or greater (clinically significant prostate cancer-2). Nonclinically significant prostate cancer was defined as either Gleason Grade 1 with cancer core length 5 mm or less and fewer than 3 positive systematic 12-core biopsies (nonclinically significant prostate cancer-1) or any Gleason Grade 1 (nonclinically significant prostate cancer-2). Definition of high risk clinically significant prostate cancer was Gleason Grade 3 or greater. Univariate and multivariate models were fitted to identify predictors of clinically significant prostate cancer risk. Results: At baseline, biopsy showed clinically significant prostate cancer-1 in 9% (45), clinically significant prostate cancer-2 in 6% (29) and nonclinically significant prostate cancer in 22% (111). At median followup of 4 years (IQR 1.6–7.1), 31% (95% CI 27–36) of 415 untreated patients had a second magnetic resonance imaging and 24% (95% CI 20–28) a second biopsy that showed clinically significant prostate cancer-1 in 5% (21/415, 95% CI 3–7), clinically significant prostate cancer-2 in 2% (7/415, 95% CI 1–3) and nonclinically significant prostate cancer in 8%. Overall incidence was 13% (66/503, 95% CI 7–21) for clinically significant prostate cancer-1, 7% (36/503, 95% CI 5–9%) for clinically significant prostate cancer-2 and 2% (12/503, 95% CI 1.1–3.7) for high risk prostate cancer. Predictors of clinically significant prostate cancer risk were prostate specific antigen density 0.15 ng/ml/ml or greater (OR 2.43, 1.19–4.21), clinical stage T2a or greater (OR 3.32, 1.69–6.53) and prostate cancer family history (OR 2.38, 1.10–6.16). Performing biopsy in patients with negative magnetic resonance imaging and prostate specific antigen density 0.15 ng/ml/ml or greater or abnormal digital rectal examination or prostate cancer family history would have decreased from 9% to 2.4% the risk of missing clinically significant prostate cancer-1 at baseline while avoiding biopsy in 56% of cases. Conclusions: The risk of clinically significant prostate cancer in a negative magnetic resonance imaging biopsy naïve population was 6% to 9% at baseline and 7% to 13% at long-term followup depending on clinically significant prostate cancer definitions. References 1. : [French ccAFU guidelines—update 2018-2020: prostate cancer]. Prog Urol, suppl., 2018; 28: S79. Google Scholar 2. : EAU-ESTRO-SIOG guidelines on prostate cancer. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol 2017; 71: 618. Google Scholar 3. : Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet 2017; 389: 815. Google Scholar 4. : MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med 2018; 378: 1767. Google Scholar 5. : Role of magnetic resonance imaging before initial biopsy: comparison of magnetic resonance imaging-targeted and systematic biopsy for significant prostate cancer detection. BJU Int 2011; 108: E171. Google Scholar 6. : PRECISION delivers on the PROMIS of MRI in early detection. Nat Rev Urol 2018; 15: 529. Google Scholar 7. : 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 Oncol 2019; 20: 100. Google Scholar 8. : What is the negative predictive value of multiparametric magnetic resonance imaging in excluding prostate cancer at biopsy? A systematic review and meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol 2017; 72: 250. Google Scholar 9. : Negative multiparametric magnetic resonance imaging for prostate cancer: what's next?Eur Urol 2018; 74: 48. Google Scholar 10. : Predictive factors of missed clinically significant prostate cancers in men with negative MRI: a systematic review and meta-analysis. J Urol 2020; 22: 24. Google Scholar 11. : Use of 5α-reductase inhibitors for benign prostate hypertrophy and risk of high grade prostate cancer: a French population-based study. BJU Int 2019; 123: 293. Google Scholar 12. : PI-RADS prostate imaging—reporting and data system: 2015, version 2. Eur Urol 2016; 69: 16. Google Scholar 13. : International Society of Urological Pathology (ISUP) grading of prostate cancer—an ISUP consensus on contemporary grading. APMIS 2016; 124: 433. Google Scholar 14. Prostate Cancer Nomograms: PSA Doubling Time. Memorial Sloan Kettering Cancer Center 2020. Available at https://www.mskcc.org/nomograms/prostate/psa_doubling_time. Accessed February 20, 2020]. Google Scholar 15. : What type of prostate cancer is systematically overlooked by multiparametric magnetic resonance imaging? An analysis from the PROMIS cohort. Eur Urol 2020; 78: 163. Google Scholar 16. : Multiparametric magnetic resonance imaging and follow-up to avoid prostate biopsy in 4259 men. BJU Int 2019; 124: 775. Google Scholar 17. : Diagnostic pathway with multiparametric magnetic resonance imaging versus standard pathway: results from a randomized prospective study in biopsy-naïve patients with suspected prostate cancer. Eur Urol 2017; 72: 282. Google Scholar 18. : Assessment of the diagnostic accuracy of biparametric magnetic resonance imaging for prostate cancer in biopsy-naive men: the biparametric MRI for detection of prostate cancer (BIDOC) study. JAMA Netw Open 2018; 1: e180219. Google Scholar 19. : Prostate imaging-reporting and data system steering committee: PI-RADS v2 status Update and future directions. Eur Urol 2019; 75: 385. Google Scholar 20. : Prostate cancer visibility on multiparametric magnetic resonance imaging: high Gleason grade and increased tumour volume are not the only important histopathological features. BJU Int 2020; 126: 237. Google Scholar 21. : Determination of the role of negative magnetic resonance imaging of the prostate in clinical practice: is biopsy still necessary?Urology 2017; 102: 190. Google Scholar 22. : Usefulness of pre-biopsy multiparametric magnetic resonance imaging and clinical variables to reduce initial prostate biopsy in men with suspected clinically localized prostate cancer. J Urol 2013; 190: 502. Link, Google Scholar 23. : Which patients with negative magnetic resonance imaging can safely avoid biopsy for prostate cancer?J Urol 2019; 201: 268. Link, Google Scholar 24. : Ruling out clinically significant prostate cancer with negative multi-parametric MRI. Int Urol Nephrol 2018; 50: 7. Google Scholar 25. : Abdominal obesity as risk factor for prostate cancer diagnosis and high grade disease: a prospective multicenter Italian cohort study. Urol Oncol 2013; 31: 997. Google Scholar 26. : Refined analysis of prostate-specific antigen kinetics to predict prostate cancer active surveillance outcomes. Eur Urol 2018; 74: 211. Google Scholar 27. : Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int 2017; 119: 449. Google Scholar 28. : Multiparametric prostate MRI: technical conduct, standardized report and clinical use. Minerva Urol Nefrol 2018; 70: 9. Google Scholar 29. : Is there additional value of 68Ga-PSMA PET/CT in patients with suspicion of prostate cancer despite negative MRI and systematic biopsy?Minerva Urol Nefrol 2020; 10: 23736. Google Scholar We obtained the agreement of all the patients after information for the use of their data and the study was declared to the CNIL (French data protection authority). © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited BySmith J (2020) This Month in Adult UrologyJournal of Urology, VOL. 205, NO. 3, (647-648), Online publication date: 1-Mar-2021. Volume 205Issue 3March 2021Page: 725-731Supplementary Materials Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.Keywordsprostate cancernegative MRIPSA densityPredictive factorsbiopsyMetricsAuthor Information Julie Buisset Department of Urology, Univ. Lille, Lille, France More articles by this author Joseph M. Norris Division of Surgery and Interventional Science, University College London, London, UK More articles by this author Philippe Puech Department of Radiology, Univ. Lille, Lille, France More articles by this author Xavier Leroy Department of Histopathology, Univ. Lille, Lille, France More articles by this author Nassima Ramdane CHU Lille, Department of Biostatistics, Lille, France Univ. Lille, CHU Lille, ULR 2694—METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, Lille, France More articles by this author Elodie Drumez CHU Lille, Department of Biostatistics, Lille, France Univ. Lille, CHU Lille, ULR 2694—METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, Lille, France More articles by this author Arnauld Villers Department of Urology, Univ. Lille, Lille, France UMR8161/CNRS-Institut de Biologie de Lille, Lille, France More articles by this author Jonathan Olivier Department of Urology, Univ. Lille, Lille, France UMR8161/CNRS-Institut de Biologie de Lille, Lille, France *Correspondence: Service d'Urologie, Hôpital Claude Huriez, Rue Michel Polonowski, 59037Lille, France [telephone: +33(0)674249071; E-mail Address: [email protected] More articles by this author Expand All We obtained the agreement of all the patients after information for the use of their data and the study was declared to the CNIL (French data protection authority). Advertisement Loading ...