Are magnetic resonance imaging and targeted biopsies needed in men with serum prostate-specific antigen over 10 ng/ml and an abnormal digital rectal examination?

The European Association of Urology currently recommends the use of risk-organized models to decrease the demand of prebiopsy magnetic resonance imaging (MRI) and unnecessary prostate biopsies in men with suspected prostate cancer (CaP). Low evidence suggests that men with prostate-specific antigen >10 ng/ml and an abnormal digital rectal examination (DRE) do not benefit from prebiopsy MRI and targeted biopsies. We aim to validate this low evidence in a sizable cohort and knowing how many clinically significant CaP (csCaP) would go undetected if only random biopsies were performed in these cases. We analyze a subset of 545 men with PSA >10 ng/ml and an abnormal DRE who met the previous criteria among 5,329 participants in a prospective trial in whom random biopsy was always performed and targeted biopsies of PI-RADS ≥3 lesions (10.2%). CsCaP (grade group ≥2) was detected in 370 men (67.9%), with 11 of 49 with negative MRI (22.5%) and 359 of 496 (72.4%) having PI-RADS ≥3. CsCaP was identified in random and targeted biopsies in 317 (88.7%) men, in targeted biopsies only in 23 (6.4%), and in random biopsies only in 19 (5.3%). If only random biopsies were performed in these men, 23 of overall 1,914 csCaP (1.2%) would go undetected in this population. Prebiopsy MRI can be saved in men with serum PSA >10 ng/ml and an abnormal DRE and only random biopsy performed. However, a close follow-up of men with negative random biopsy seems appropriate due to the high-risk of csCaP in these men.