Abstract

PurposeWe aimed to develop and externally validate a nomogram based on MRI volumetric parameters and clinical information for deciding when SBx should be performed in addition to TBx in man with suspicious prostate MRI.Materials and methodsRetrospective analyses of single (IMPROD, NCT01864135) and multi-institution (MULTI-IMPROD, NCT02241122) clinical trials. All men underwent a unique rapid biparametric magnetic resonance imaging (IMPROD bpMRI) consisting of T2-weighted imaging and three separate DWI acquisitions. Men with IMPROD bpMRI Likert scores of 3–5 were included. Logistic regression models were developed using IMPROD trial (n = 122) and validated using MULTI-IMPROD trial (n = 262) data. The model’s performance was evaluated in the terms of PCa detection with Gleason Grade Group 1 (clinically insignificant prostate cancer, iPCa) and > 1 (clinically significant prostate cancer, csPCa). Net benefits and decision curve analyses (DCA) were compared. Combined biopsies were used for reference.ResultsThe developed nomogram included age, PSA, prostate volume, MRI suspicion score (IMPROD bpMRI Likert or PIRADsv2.1 score), MRI-suspicion lesion volume percentage, and lesion location. All these variables were significant predictors of csPCa in SBx in multivariable analysis. In the validation cohort (n = 262) using different nomogram cutoffs, 19–43% of men would have avoided SBx while missing 1–4% of csPCa and avoiding detection of 9–20% of iPCa. Similar performance was found for nomograms using IMPROD bpMRI Likert score or v2.1.ConclusionsThe developed nomogram demonstrated potential to select men with a clinical suspicion of PCa who would benefit from performing SBx in addition to TBx. Public access to the nomogram is provided at:https://petiv.utu.fi/multiimprod/.

Highlights

  • In the recent years, Magnetic Resonance Imaging (MRI) is increasingly used in the diagnostic pathways for prostate cancer (PCa)

  • No difference was found in clinically significant PCa (csPCa) detection rate according to PIRADsv2.1 score

  • The total volume of the suspicious lesion on MRI, index lesion volume and the percentage of prostate involved by cancer emerged as important predictors csPCa in SBx, TBx and all cores (SBx + TBx)

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Summary

Introduction

Magnetic Resonance Imaging (MRI) is increasingly used in the diagnostic pathways for prostate cancer (PCa). Given the reported superiority of the MRI-targeted biopsy (TBx) compared to systematic biopsy (SBx) in recent prospective clinical trials (PROMIS [3], PRECISION [4], and MRI-FIRST [5]), there is a growing interest to evaluate if SBx is needed in addition to TBx in men with a clinical suspicion of PCa. Avoiding SBx would reduce the risks of infection, bleeding and pain associated with additional cores sampling [6, 7]. A recent Cochrane meta-analysis of the results of studies evaluating MRI and MRI-targeted biopsy suggests that omitting systematic biopsy would miss approximately 16% of csPCa in biopsy-naive patients and 10% in the repeat-biopsy setting

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