Bryant Richard J, Marian Ioana R, Williams Roxanne, Lopez J Francisco, Mercader Claudia, Raslan Mutie, Berridge Christopher, Whitburn Jessica, Campbell Teresa, Tuck Steve, Barber Vicki S, Scaife Jessica, Hewitt Aimi, Taylor Amy, Ooms Alexander, Landeiro Filipa, Little Matthew, Wolstenholme Jane, Ghosh Sukanya, Reynard John M, Hamdy Freddie C, Liew Matthew P C, Leslie Tom A, Catto James W F, Rosario Derek J, Omer Altan, Good Daniel W, Gray Robert Hr, Kommu Sashi, Chung Daniel, Wells Hannah, Narahari Krishna, Macpherson Ruth E, Verrill Clare, Eddy Ben, Yamamoto Hide, Lamb Alastair D
Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Surgical Intervention Trials Unit, University of Oxford, Oxford, UK.
Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Lancet Oncol. 2025 May;26(5):583-595. doi: 10.1016/S1470-2045(25)00100-7. Epub 2025 Mar 23.
Prostate cancer diagnosis requires biopsy, traditionally performed under local anaesthetic with ultrasound guidance via a transrectal approach (TRUS). Local anaesthetic ultrasound-guided transperineal biopsy (LATP) is gaining popularity in this setting; however, there is uncertainty regarding prostate sampling, infection rates, tolerability, side-effects, and cost-effectiveness. TRANSLATE was a randomised clinical trial that aimed to compare detection of Gleason Grade Group (GGG) 2 or higher prostate cancer, side-effects, tolerability, and patient-reported outcomes, after LATP versus TRUS biopsy.
In this randomised clinical trial which was done at ten hospitals in the UK, patients aged 18 years or older were eligible if investigated for suspected prostate cancer based on elevated age-specific prostate-specific antigen or abnormal digital rectal examination, and if biopsy-naive having received pre-biopsy MRI on a 1·5 or higher Tesla scanner. Individuals were excluded if they had any previous prostate biopsy, extensive local disease easily detectable by any biopsy (prostate-specific antigen >50 ng/mL or entire gland replaced by tumour on MRI), symptoms of concurrent or recent urinary tract infection, history of immunocompromise, need for enhanced antibiotic prophylaxis, absent rectum, or inability to position in lithotomy. Participants were randomly assigned in a 1:1 ratio to receive LATP or TRUS biopsy, using web-based software with a randomisation sequence using a minimisation algorithm to ensure balanced allocation across biopsy groups for minimisation factors (recruitment site, and location of the MRI lesion). The primary outcome was detection of GGG 2 or higher prostate cancer, analysed in the modified intention-to-treat population (all randomly assigned to treatment who had a biopsy result available). Key secondary endpoints assessing post-biopsy adverse events were infection, bleeding, urinary and sexual function, tolerability, and patient-reported outcomes. This trial is registered with ClinicalTrials.gov (NCT05179694) and at ISRCTN (ISRCTN98159689), and is complete.
Between Dec 3, 2021, and Sept 26, 2023, 2078 (76%) of 2727 assessed individuals were eligible, and 1126 (41%) of 2727 agreed to participate. 1044 (93%) of the 1126 participants were White British. Participants were allocated to TRUS (n=564) or LATP (n=562) biopsy, and were followed up at time of biopsy, and at 7 days, 35 days, and 4 months post-biopsy. We found GGG 2 or higher prostate cancer in 329 (60%) of 547 participants with biopsy results randomly assigned to LATP compared with 294 (54%) of 540 participants with biopsy results randomly assigned to TRUS biopsy (odds ratio [OR] 1·32 [95% CI 1·03-1·70]; p=0·031). Infection requiring admission to hospital within 35 days post-biopsy occurred in 2 (<1%) of 562 participants in the LATP group compared with 9 (2%) of 564 in the TRUS group. No statistically significant difference was observed in the reporting of overall biopsy-related complications (LATP 454 [81%] of 562 vs TRUS 436 [77%] of 564, OR 1·23 [95% CI 0·93 to 1·65]), urinary retention requiring catheterisation (LATP 35 [6%] of 562 vs TRUS 27 [5%] of 564), urinary symptoms (median International Prostate Symptom Score: LATP 8 [IQR 4-14] vs TRUS 8 [4-13], OR 0·36 [95% CI -0·38 to 1·10]), nor sexual function (median International Index of Erectile Function score: LATP 5 [2-25] vs TRUS 8 [3-24], OR -0·60 [-1·79 to 0·58]) at 4 months after biopsy. Trial participants more commonly reported LATP biopsy to be immediately painful and embarrassing compared with TRUS (LATP 216 [38%] of 562 vs TRUS 153 [27%] of 564; OR 1·84 [95% CI 1·40 to 2·43]). Serious adverse events occurred in 14 (2%) of 562 participants in the LATP group and 25 (4%) of 564 in the TRUS group.
Among biopsy-naive individuals being investigated for possible prostate cancer, biopsy with LATP led to greater detection of GGG 2 or higher disease compared with TRUS. These findings will help to inform patients, clinicians, clinical guidelines, and policy makers regarding the important trade-offs between LATP and TRUS prostate biopsy.
National Institute for Health and Care Research (NIHR) Health Technology Assessment.
前列腺癌的诊断需要进行活检，传统上是在局部麻醉下，通过经直肠途径（TRUS）在超声引导下进行。局部麻醉超声引导下经会阴活检（LATP）在这种情况下越来越受欢迎；然而，在前列腺采样、感染率、耐受性、副作用和成本效益方面存在不确定性。TRANSLATE是一项随机临床试验，旨在比较LATP与TRUS活检后Gleason分级组（GGG）2级或更高的前列腺癌的检测、副作用、耐受性以及患者报告的结果。
在这项于英国十家医院进行的随机临床试验中，年龄在18岁及以上的患者，如果基于年龄特异性前列腺特异性抗原升高或直肠指检异常而被怀疑患有前列腺癌，并且在1.5特斯拉或更高场强的扫描仪上进行活检前MRI检查且未曾接受过活检，则符合入选标准。如果个体有过前列腺活检史、任何活检都容易检测到的广泛局部疾病（前列腺特异性抗原>50 ng/mL或MRI显示整个腺体被肿瘤取代）、并发或近期尿路感染的症状、免疫功能低下史、需要加强抗生素预防、直肠缺失或无法采取截石位，则被排除。参与者以1:1的比例随机分配接受LATP或TRUS活检，使用基于网络的软件，采用最小化算法的随机序列，以确保在活检组之间平衡分配最小化因素（招募地点和MRI病变位置）。主要结局是检测GGG 2级或更高的前列腺癌，在改良意向性治疗人群（所有随机分配接受治疗且有活检结果的患者）中进行分析。评估活检后不良事件的关键次要终点是感染、出血、泌尿和性功能、耐受性以及患者报告的结果。该试验已在ClinicalTrials.gov（NCT0517969）和ISRCTN（ISRCTN98159689）注册，现已完成。
在2021年12月3日至2023年9月26日期间，2727名评估个体中有2078名（76%）符合条件，2727名中有1126名（41%）同意参与。1126名参与者中有1044名（93%）为英国白人。参与者被分配接受TRUS（n = 564）或LATP（n = 562）活检，并在活检时以及活检后7天、35天和4个月进行随访。我们发现，随机分配接受LATP活检且有活检结果的547名参与者中有329名（60%）检测到GGG 2级或更高的前列腺癌，而随机分配接受TRUS活检且有活检结果的540名参与者中有294名（54%）检测到（优势比[OR] 1.32 [95% CI 1.03 - 1.70]；p = 0.031）。LATP组562名参与者中有2名（<1%）在活检后35天内需要住院治疗的感染，而TRUS组564名中有9名（2%）。在总体活检相关并发症的报告中未观察到统计学显著差异（LATP组562名中有454名[81%]，TRUS组564名中有436名[77%]，OR 1.23 [95% CI 0.93至1.65]），活检后需要导尿的尿潴留（LATP组562名中有35名[6%]，TRUS组564名中有27名[5%]），泌尿症状（国际前列腺症状评分中位数：LATP组8 [四分位间距4 - 14]，TRUS组8 [4 - 13]，OR 0.36 [95% CI -0.38至1.10]），活检后4个月的性功能（国际勃起功能指数评分中位数：LATP组5 [2 - 25]，TRUS组8 [3 - 24]，OR -0.60 [-1.79至0.58]）。与TRUS相比，试验参与者更常报告LATP活检立即感到疼痛和尴尬（LATP组562名中有216名[38%]，TRUS组564名中有153名[27%]；OR 1.84 [95% CI 1.40至2.43]）。LATP组562名参与者中有14名（2%）发生严重不良事件，TRUS组564名中有25名（4%）。
在因可能患有前列腺癌而接受检查的未接受过活检的个体中，与TRUS相比，LATP活检能更有效地检测出GGG 2级或更高的疾病。这些发现将有助于告知患者、临床医生、临床指南制定者和政策制定者关于LATP和TRUS前列腺活检之间重要的权衡。
国家卫生与保健研究所（NIHR）卫生技术评估。
