Thomas Stonier1, Nick Simson2, Taimur Shah3, Niyati Lobo4, Tarik Amer5, Su-Min Lee6, Edward Bass7, Edwin Chau8, Alistair Grey9, Neil McCartan10, Peter Acher8, Imran Ahmad5, Nimalan Arumainayagam7, Dominic Brown11, Alex Chapman7, Deborah Elf11, Thomas Hartington10, Ibrahim Ibrahim5, Hing Leung5, Sidath Liyanage8, Catherine Lovegrove3, Theo Malthouse4, Bilal Mateen12, Kiki Mistry7, Iain Morrison4, Sarika Nalagatla5, Raj Persad6, Alvan Pope13, Heminder Sokhi14, Hira Syed7, Sergey Tadtayev7, Meera Tharmaratnam11, Ahmed Qteishat11, Saiful Miah3, Mark Emberton10, Caroline Moore10, Tom Walton15, Ben Eddy4, Hashim U Ahmed3. 1. King's College Hospital, London, UK; Princess Alexandra Hospital, Harlow, UK. Electronic address: Thomas.stonier@nhs.net. 2. Princess Alexandra Hospital, Harlow, UK; Guy's and St Thomas' Hospital, London, UK. 3. Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Imperial College Healthcare NHS Trust, London, UK. 4. Kent and Canterbury Hospital, East Kent Hospital University Foundation Trust, Kent, UK. 5. Queen Elizabeth University Hospital, Glasgow, UK. 6. Southmead Hospital, North Bristol NHS Trust, Bristol, UK. 7. Ashford and St Peter's Hospitals NHS Foundation Trust, Chertsey, UK. 8. Southend University Hospital NHS Foundation Trust, Southend, UK. 9. Imperial Urology, Imperial College Healthcare NHS Trust, London, UK; Division of Surgical and Interventional Sciences, University College London, London, UK; Department of Urology, Barts Health NHS Trust, London, UK. 10. Division of Surgical and Interventional Sciences, University College London, London, UK. 11. Princess Alexandra Hospital, Harlow, UK. 12. King's College Hospital, London, UK. 13. The Hillingdon Hospitals NHS Foundation Trust, Hillingdon, UK. 14. The Hillingdon Hospitals NHS Foundation Trust, Hillingdon, UK; Paul Strickland Scanner Centre, Mount Vernon Hospital, Northwood, UK. 15. Nottingham University Hospitals NHS Trust, Nottingham, UK.
Abstract
BACKGROUND: Multiparametric magnetic resonance imaging (mpMRI) is now recommended prebiopsy in numerous healthcare regions based on the findings of high-quality studies from expert centres. Concern remains about reproducibility of mpMRI to rule out clinically significant prostate cancer (csPCa) in real-world settings. OBJECTIVE: To assess the diagnostic performance of mpMRI for csPCa in a real-world setting. DESIGN, SETTING, AND PARTICIPANTS: A multicentre, retrospective cohort study, including men referred with raised prostate-specific antigen (PSA) or an abnormal digital rectal examination who had undergone mpMRI followed by transrectal or transperineal biopsy, was conducted. Patients could be biopsy naïve or have had previous negative biopsies. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary definition for csPCa was International Society of Urological Pathology (ISUP) grade group (GG) ≥2 (any Gleason ≥7); the accuracy for other definitions was also evaluated. RESULTS AND LIMITATIONS: Across ten sites, 2642 men were included (January 2011-November 2018). Mean age and PSA were 65.3yr (standard deviation [SD] 7.8yr) and 7.5ng/ml (SD 3.3ng/ml), respectively. Of the patients, 35.9% had "negative MRI" (scores 1-2); 51.9% underwent transrectal biopsy and 48.1% had transperineal biopsy, with 43.4% diagnosed with csPCa overall. The sensitivity and negative predictive value (NPV) for ISUP GG≥2 were 87.3% and 87.5%, respectively. The NPVs were 87.4% and 88.1% for men undergoing transrectal and transperineal biopsy, respectively. Specificity and positive predictive value of MRI were 49.8% and 49.2%, respectively. The sensitivity and NPV increased to 96.6% and 90.6%, respectively, when a PSA density threshold of 0.15ng/ml/ml was used in MRI scores 1-2; these metrics increased to 97.5% and 91.2%, respectively, for PSA density 0.12ng/ml/ml. ISUP GG≥3 (Gleason ≥4+3) was found in 2.4% (15/617) of men with MRI scores 1-2. They key limitations of this study are the heterogeneity and retrospective nature of the data. CONCLUSIONS: Multiparametric MRI when used in real-world settings is able to rule out csPCa accurately, suggesting that about one-third of men might avoid an immediate biopsy. Men should be counselled about the risk of missing some significant cancers. PATIENT SUMMARY: Multiparametric magnetic resonance imaging (MRI) is a useful tool for ruling out prostate cancer, especially when combined with prostate-specific antigen density (PSAD). Previous results published from specialist centres can be reproduced at smaller institutions. However, patients and their clinicians must be aware that an early diagnosis of clinically significant prostate cancer could be missed in nearly 10% of patients by relying on MRI and PSAD alone.
BACKGROUND: Multiparametric magnetic resonance imaging (mpMRI) is now recommended prebiopsy in numerous healthcare regions based on the findings of high-quality studies from expert centres. Concern remains about reproducibility of mpMRI to rule out clinically significant prostate cancer (csPCa) in real-world settings. OBJECTIVE: To assess the diagnostic performance of mpMRI for csPCa in a real-world setting. DESIGN, SETTING, AND PARTICIPANTS: A multicentre, retrospective cohort study, including men referred with raised prostate-specific antigen (PSA) or an abnormal digital rectal examination who had undergone mpMRI followed by transrectal or transperineal biopsy, was conducted. Patients could be biopsy naïve or have had previous negative biopsies. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary definition for csPCa was International Society of Urological Pathology (ISUP) grade group (GG) ≥2 (any Gleason ≥7); the accuracy for other definitions was also evaluated. RESULTS AND LIMITATIONS: Across ten sites, 2642 men were included (January 2011-November 2018). Mean age and PSA were 65.3yr (standard deviation [SD] 7.8yr) and 7.5ng/ml (SD 3.3ng/ml), respectively. Of the patients, 35.9% had "negative MRI" (scores 1-2); 51.9% underwent transrectal biopsy and 48.1% had transperineal biopsy, with 43.4% diagnosed with csPCa overall. The sensitivity and negative predictive value (NPV) for ISUP GG≥2 were 87.3% and 87.5%, respectively. The NPVs were 87.4% and 88.1% for men undergoing transrectal and transperineal biopsy, respectively. Specificity and positive predictive value of MRI were 49.8% and 49.2%, respectively. The sensitivity and NPV increased to 96.6% and 90.6%, respectively, when a PSA density threshold of 0.15ng/ml/ml was used in MRI scores 1-2; these metrics increased to 97.5% and 91.2%, respectively, for PSA density 0.12ng/ml/ml. ISUP GG≥3 (Gleason ≥4+3) was found in 2.4% (15/617) of men with MRI scores 1-2. They key limitations of this study are the heterogeneity and retrospective nature of the data. CONCLUSIONS: Multiparametric MRI when used in real-world settings is able to rule out csPCa accurately, suggesting that about one-third of men might avoid an immediate biopsy. Men should be counselled about the risk of missing some significant cancers. PATIENT SUMMARY: Multiparametric magnetic resonance imaging (MRI) is a useful tool for ruling out prostate cancer, especially when combined with prostate-specific antigen density (PSAD). Previous results published from specialist centres can be reproduced at smaller institutions. However, patients and their clinicians must be aware that an early diagnosis of clinically significant prostate cancer could be missed in nearly 10% of patients by relying on MRI and PSAD alone.
Authors: Alberto Artiles Medina; Rafael Rodríguez-Patrón Rodríguez; Mercedes Ruiz Hernández; Marina Mata Alcaraz; Silvia García Barreras; Guillermo Fernández Conejo; Agustín Fraile Poblador; Enrique Sanz Mayayo; Francisco Javier Burgos Revilla Journal: Res Rep Urol Date: 2021-09-27
Authors: Jeroen S Reijnen; Jon B Marthinsen; Alf O Tysland; Christoph Müller; Irina Schönhardt; Erlend Andersen; Therese Seierstad; Knut H Hole Journal: Abdom Radiol (NY) Date: 2021-08-20