Objectives: This study aimed to determine the diagnostic accuracy of bi-parametric magnetic resonance imaging (bpMRI) for clinically significant (CS) prostate cancer (PCa), and to assess the suitability of a new diagnostic pathway using bpMRI and prostate-specific antigen density (PSAd) to determine the need for biopsy. Methods: A total of 386 patients referred to one UK cancer centre with suspected PCa across 12 months from 2017 to 2018 underwent bpMRI, with a Prostate Imaging Reporting and Data System (PIRADS) score assigned. Of these, 266 (69%) were biopsied, with 150 CS-PCa (a Gleason score of 7 or a Gleason score of 3 with core length ⩾5 mm) detected: a 57% diagnostic yield. Imaging, PSAd and biopsy results were collated, and a confusion matrix was calculated. Results: Twenty-three men with PIRADS 1 were biopsied, with two CS-PCa detected: PSAd M=0.19 ( SD=0.07). Twenty-one men with PIRADS 2 lesions were biopsied, with one CS-PCa detected: PSAd was 0.28. Seventy-five men with PIRADS 3 were biopsied, with 25 CS-PCa detected: PSAd M=0.26 ( SD=0.16). Fifty-seven men with PIRADS 4 were biopsied, with 46 CS-PCa detected: PSAd M=0.26 ( SD=0.16). Ninety men with PIRADS 5 were biopsied, with 83 CS-PCa detected: PSAd M=0.55 ( SD=0.63). Among the 266 biopsied patients, a pathway offering biopsy if PIRADS is ⩾3 or PSAd ⩾0.1 spares 11 (4.2%) biopsies compared to baseline practice, with a sensitivity of 100% and a specificity of 10.1%, for biopsy-detected CS-PCa. The diagnostic yield is 61.8%. Conclusion: BpMRI is comparable to multi-parametric MRI for assessing need for biopsy in suspected PCa, albeit with lower specificity. A diagnostic pathway using bpMRI and PSAd can be safely used to avoid biopsy in men at low risk, increasing diagnostic yield of biopsy while reducing overdiagnosis and avoiding the risks and costs associated with gadolinium contrast. Level of evidence: Level 4.
The Use of Magnetic Resonance Imaging in the Prostate Cancer Primary Diagnostic Pathway: Is It Ready for Primetime?
