Abstract

The main disadvantages of the current diagnostic pathway in men with an elevated risk of prostate cancer (PCa) are that: (1) systematic transrectal ultrasound (TRUS) biopsy misses a substantial proportion (20%) of significant PCa because of inherent systematic sampling errors, especially in the anterior gland [1,2]; (2) misclassifies pathologic status including Gleason score (Gl) and tumour stage [3]; and (3) detects a high proportion of men with disease that is unlikely to be harmful (clinically insignificant), with subsequently overtreatments resulting in unintended harm [4]. The latter was the main reason for the U.S. Preventive Services Task Force recommendation against prostate-specific antigenbased screening for prostate cancer in 2012 [5].

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