In 41 months, 740 men at 11 centres were recruited; 576 underwent all three tests. Of 150 with MRI score 1-2, 8 (5.1%) had any Gleason >/=3+4 disease on TRUS-biopsy. In 75 where TRUS-biopsy showed Gleason 3+3 of any MCCL, 61/75 (81%) had Gleason 3+4, 8/75 (11%) Gleason 4+3 and 0/75 (0%) Gleason >/=4+5. For definition1 csPCa, TRUS-biopsy sensitivity remained stable and low across MP-MRI Likert scores (35%-52%). For definition2 csPCa and any cancer, sensitivity increased with higher MP-MRI score. Negative predictive value varied due to varying disease prevalence but for all cancer thresholds declined with increasing MP-MRI score.
ConclusionsTRUS-biopsy in the setting of MP-MRI Likert scores 1-2 finds Gleason 3+4 disease in only 1 in 20 men. Further, for any csPCa definition, TRUS-biopsy had poor sensitivity and variable but low NPV across MP-MRI scores. Men undergoing TRUS-biopsy without targeting in the setting of MP-MRI score 3 to 5 should be advised to undergo a repeat (targeted) biopsy.