Protocol for the TRANSLATE prospective, multi‐centre, randomised clinical trial.

The present investigation is conducted to determine whether local anesthetic transperineal (LATP) prostate biopsy improves the detection of clinically significant prostate cancer (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥ two diseases, compared to transrectal ultrasound-guided (TRUS) prostate biopsy, in biopsy-naïve men undergoing biopsy based on suspicion of csPCa. Also to compare infection rates, health-related quality of life (HRQoL), patient-reported procedure tolerability, biopsy-related complications, number of subsequent prostate biopsy procedures required, cost-effectiveness, other histological parameters, and burden and rate of detection of clinically insignificant PCa (ciPCa) in men undergoing these two types of prostate biopsy. TRANSLATE trial is investigating whether LATP biopsy leads to a higher rate of detection of csPCa compared to TRUS prostate biopsy. Both biopsies are performed with an average of 12 systematic cores in 6 sectors, plus 3-5 target cores per multi-parametric/bi-parametric magnetic resonance imaging lesion. This trial provides robust prospective data to determine the diagnostic ability of LATP biopsy versus TRUS biopsy in the primary diagnostic setting.