We evaluated performance of transrectal ultrasound-guided systematic (TRUS) biopsy compared to transperineal template mapping (TPM) with a 5mm sampling frame, stratified by MP-MRI Likert score within the PROMIS study.

Biopsy-naïve men due prostate biopsy for elevated PSA and/or abnormal digital rectal examination underwent MP-MRI, TPM and TRUS biopsies, conducted and reported blind to other test results. Clinically significant prostate cancer (csPCa) was primarily defined as Gleason >/=4+3 or maximum cancer core length (MCCL) >/=6mm of any grade, and secondarily Gleason >/=3+4 or MCCL >/=4mm of any grade.

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.

TRUS-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.

The Journal of urology. 2019 Jul 23 [Epub ahead of print]

C Lovegrove, S Miah, A El-Shater Bosaily, S Bott, L Brown, N Burns-Cox, T Dudderidge, A Freeman, A Henderson, R Hindley, R Kaplan, A Kirkham, R Oldroyd, C Parker, R Persad, S Punwani, D Rosario, I Shergill, M Winkler, M Emberton, H U Ahmed

Department of Urology, Imperial College Healthcare NHS Trust, London, UK., Department of Urology, UCLH NHS Foundation Trust, London, UK., Department of Urology, Frimley Park Hospital, NHS Frimley Health Foundation Trust, Frimley, UK., MRC Clinical Trials Unit at UCL, London, UK., Department of Urology, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, UK., Department of Urology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Department of Histopathology, UCLH NHS Foundation Trust, London, UK., Department of Urology, Maidstone and Tunbridge Wells NHS Trust, Tunbridge Wells, UK., Department of Urology, Hampshire Hospitals NHS Foundation Trust, UK., Department of Radiology, UCLH NHS Foundation Trust, London, UK., Public and patient representative, Nottingham, UK., Department of Academic Urology, Royal Marsden Hospital, Sutton, UK., Department of Urology, North Bristol NHS Trust, Bristol, UK., Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK., Department of Urology, Wrexham Maelor Hospital NHS Trust, Wrexham, UK.