No large multicentre prospective studies ever addressed the outcomes of mpMRI targeted fusion transperineal biopsy (TPFBx) under local anesthesia (LA). The debate upon best biopsy modality is still open.
We prospectively screened for inclusion 1,327 men with a positive mpMRI undergoing TPFBx (targeted cores and systematic cores) under LA, at two tertiary referral institutions, from Sep2016 to May2019. Primary outcomes was CSPCa detection according to: i) ISUP>1 or ISUP 1 with >50% involvement of PCa in a single core or >2 cores (D1); ii) ISUP >1 (D2). Secondary outcomes were: ii) assessment of peri-procedural pain (NRS) and timings; iii) erectile (IIEF-5) and urinary (IPSS) function changes; iv) complications. We also investigated the value of systematic sampling and concordance with radical prostatectomy (RP).
We included 1014 men. CSPCa was diagnosed in 39.4% (n=400). The procedure was tolerable (NRS pain 3.1 ±2.3), with no impact on erectile (p=0.45) or urinary (p=0.58) function, and low complications (Clavien 1 or 2 n=8, >2 n=0). No post-biopsy sepsis were recorded. Twenty-two men (95%CI: 17-29) needed to undergo additional systematic biopsy to diagnose one csPCa missed by target biopsies (D1). ISUP concordance of biopsies with RP was k=0.40 (95% CI= 0.31-0.49) for target cores alone and k=0.65 (95% CI 0.57-0.72, p<0.05) overall.
TPFBx under LA yield good CSPCa detection and are feasible, quick, well-tolerated and safe. Infectious risk is negligible. Addition of systematic to targeted cores may not be needed in all men, although it improves CSPCa detection and concordance with RP.

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