主要目的：确定在临床疑似有临床有意义的前列腺癌（csPCa）的未做过活检的男性中，局麻经会阴前列腺（LATP）活检是否比经直肠超声引导（TRUS）前列腺活检更能够检测出具有国际泌尿病理学会（ISUP）分级组别≥2的疾病（即任何Gleason模式4疾病），以进行比较。同时，比较以下诸如（i）感染率，（ii）与健康相关的生命质量，（iii）患者报告的手术耐受性，（iv）患者报告的活检相关并发症（包括出血，瘀伤，疼痛，勃起功能丧失），（v）需要进行次数的前列腺活检程序，（vi）成本效益，（vii）其他组织学参数，以及（viii）在这两种前列腺活检下，在患者中可检出的低临床意义的PCa（ISUP等级组别1疾病）的负担和患病率。TRANSLATE 试验是一个英国范围内的多中心、随机临床试验，符合诊断测试评估一级证据的标准。TRANSLATE 正在研究 LATP 活检是否会导致比 TRUS 前列腺活检更高的 csPCa 检出率。在进行这两种前列腺活检时，均使用平均12个系统核心在六个部位（取决于前列腺大小）以及每个多参数/两参数磁共振成像病灶中的三至五个靶向核心。LATP 活检使用超声探头安装的针导设备（ 'Precision-Point' 或 BK UA1232 系统）进行。TRUS 活检则按每家医院的标准实践进行。该研究具有 90% 的功率来检测 10% 的差异（假设 LATP 活检的 csPCa 检出率为 55%，TRUS 活检为 45%）。需要招募总计 1042 名疑似前列腺癌但未进行活检的男性参与研究。本试验将提供严格的前瞻性数据，以确定 LATP 活检与 TRUS 活检在初步诊断设置中的诊断能力。© 2023 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.

Primary objectives: to determine whether local anaesthetic transperineal prostate (LATP) biopsy improves the detection of clinically significant prostate cancer (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥2 disease (i.e., any Gleason pattern 4 disease), compared to transrectal ultrasound-guided (TRUS) prostate biopsy, in biopsy-naïve men undergoing biopsy based on suspicion of csPCa.to compare (i) infection rates, (ii) health-related quality of life, (iii) patient-reported procedure tolerability, (iv) patient-reported biopsy-related complications (including bleeding, bruising, pain, loss of erectile function), (v) number of subsequent prostate biopsy procedures required, (vi) cost-effectiveness, (vii) other histological parameters, and (viii) burden and rate of detection of clinically insignificant PCa (ISUP Grade Group 1 disease) in men undergoing these two types of prostate biopsy.The TRANSLATE trial is a UK-wide, multicentre, randomised clinical trial that meets the criteria for level-one evidence in diagnostic test evaluation. TRANSLATE is investigating whether LATP biopsy leads to a higher rate of detection of csPCa compared to TRUS prostate biopsy. Both biopsies are being performed with an average of 12 systematic cores in six sectors (depending on prostate size), plus three to five target cores per multiparametric/bi-parametric magnetic resonance imaging lesion. LATP biopsy is performed using an ultrasound probe-mounted needle-guidance device (either the 'Precision-Point' or BK UA1232 system). TRUS biopsy is performed according to each hospital's standard practice. The study is 90% powered to detect a 10% difference (LATP biopsy hypothesised at 55% detection rate for csPCa vs 45% for TRUS biopsy). A total of 1042 biopsy-naïve men referred with suspected PCa need to be recruited.This trial will provide robust prospective data to determine the diagnostic ability of LATP biopsy vs TRUS biopsy in the primary diagnostic setting.© 2023 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.