Prostate cancer detection, tolerability and safety of transperineal prostate biopsy under local-anaesthesia versus standard transrectal biopsy in biopsy-naïve men: a pragmatic, parallel group, randomized-controlled study

Abstract

Objectives: Local-anaesthetic transperineal biopsy (LATPB) of prostate is an alternative to TRUS biopsy (TRUSB) to investigate men at risk of prostate cancer (PCa). This study evaluated LATPB against TRUSB in PCa detection, complication rates and patient tolerability. Patients and Methods: A parallel group, randomized study of men suspected with PCa were allocated in a 1:1 ratio to LATPB systematically according to modified-Ginsburg protocol, or standard 12-core TRUSB. Inclusion-criteria: biopsy-naïve, age 40-80, PSA≤20ng/mL, suspected tumour clinical stage ≤T2 on DRE. Exclusion-criteria: known history of PCa. Primary endpoint: difference in proportion of patients with clinically significant PCa on histology. Secondary endpoints: patient tolerability comparison measured by visual analogue scale (VAS) and health-related QoL questionnaires at <24 hours and <1 month, and post-biopsy sepsis rates. Results: 266 patients underwent randomisation. 47/134 (35.1%) in LATPB arm had PCa vs 33/132 (25.0%) in TRUSB arm (p<0.05). No significant difference in detecting clinically significant PCa between the two arms (16.4% vs 14.4%, p=0.74). There was no statistically significant difference in VAS (p=0.14), IPSS change (p=0.18), or post-biopsy retention (p=0.107). Post-biopsy reduction in IIEF-5 was more significant in LATPB arm (p<0.05). 11 (8.3%) patients in TRUSB arm developed sepsis but none following LATPB. Study was terminated early following interim analysis on ethical grounds due to significant difference in sepsis rates. Conclusion: This study demonstrated statistically higher PCa detection rate with LATPB in biopsynaïve men at clinical risk for PCa, although clinically significant PCa detection rates were equivalent between the two techniques. LATPB was tolerated as well as TRUSB, but was not associated with any sepsis. This study provided a high-level evidence that LATPB should be the current standard prostate biopsy choice of technique.