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前列腺活检技术 TRANSLATE 前瞻性、多中心、随机临床试验方案。

Protocol for the TRANSLATE prospective, multicentre, randomised clinical trial of prostate biopsy technique.

机构信息

Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.

Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.

出版信息

BJU Int. 2023 Jun;131(6):694-704. doi: 10.1111/bju.15978. Epub 2023 Feb 21.

DOI:10.1111/bju.15978

PMID:36695816

Abstract

OBJECTIVES

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.

SECONDARY OBJECTIVES

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.

PATIENTS AND METHODS

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.

CONCLUSIONS

This trial will provide robust prospective data to determine the diagnostic ability of LATP biopsy vs TRUS biopsy in the primary diagnostic setting.

摘要

目的

主要目的：确定经会阴局部麻醉前列腺（LATP）活检是否比经直肠超声引导（TRUS）前列腺活检在活检初治且怀疑患有临床显著前列腺癌（csPCa）的男性中提高了对临床显著前列腺癌（csPCa）的检测率，csPCa 的定义为国际泌尿病理学会（ISUP）分级组≥2 级（即任何 Gleason 模式 4 级疾病）。

次要目的

比较（i）感染率，（ii）健康相关生活质量，（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）后续需要进行的前列腺活检次数，（vi）成本效益，（vii）其他组织学参数，以及（viii）接受这两种类型前列腺活检的男性中临床意义不显著的前列腺癌（ISUP 分级组 1 级疾病）的检出率和负担。

患者和方法

TRANSLATE 试验是一项英国范围内的多中心随机临床试验，符合诊断性试验评估一级证据的标准。TRANSLATE 正在研究经会阴局部麻醉前列腺活检是否比经直肠超声前列腺活检导致更高的 csPCa 检出率。这两种活检均采用平均 12 个系统核心在六个部位（取决于前列腺大小），外加每 3 至 5 个多参数/双参数磁共振成像病变的靶向核心进行。经会阴局部麻醉前列腺活检使用超声探头安装的针引导装置（“Precision-Point”或 BK UA1232 系统）进行。TRUS 活检根据每家医院的标准操作进行。该研究有 90%的能力检测到 10%的差异（假设 LATP 活检检测 csPCa 的检出率为 55%，TRUS 活检为 45%）。需要招募总共 1042 名活检初治且怀疑患有前列腺癌的男性。