2025-03-24 オックスフォード大学
オックスフォード大学を中心とする英国の研究チームは、新しい前立腺生検手法が診断精度を向上させることを明らかにしました。従来の経直腸的生検(直腸壁を通過する方法)に対し、経会陰的生検(陰嚢と肛門の間の皮膚を通過する方法)を比較した結果、後者が臨床的に重要な前立腺がんの検出率を高めることが確認されました。
◆この研究は、英国各地から1,126人の男性を対象に実施され、National Institute for Health and Care Research(NIHR)の資金提供を受けています。経会陰的生検は、抗生物質の使用を必要とせず、抗生物質耐性のリスクを低減する利点があります。一方で、手技に要する時間が長く、患者が感じる痛みも増加することが報告されています。研究成果は『The Lancet Oncology』誌に掲載され、マドリードで開催された欧州泌尿器学会の年次総会で発表されました。
<関連情報>
- https://www.ox.ac.uk/news/2025-03-24-new-biopsy-technique-found-improve-prostate-cancer-detection
- https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00100-7/fulltext?rss=yes
前立腺癌検出における局所麻酔経会陰生検と経直腸前立腺生検の比較(TRANSLATE):多施設共同無作為化比較試験 Local anaesthetic transperineal biopsy versus transrectal prostate biopsy in prostate cancer detection (TRANSLATE): a multicentre, randomised, controlled trial
Richard J Bryant, PhD ∙ Ioana R Marian, MSc ∙ Roxanne Williams, BSc (Hons) ∙ J Francisco Lopez, MSc ∙ Claudia Mercader, FEBU ∙ Mutie Raslan, FRCS (Urol)∙ et al.
The Lancet Oncology Published: March 23, 2025
DOI:https://doi.org/10.1016/S1470-2045(25)00100-7
00100-7/asset/e47f0e6d-41a0-468d-94e1-86fc0f35f835/main.assets/gr1.jpg "前立腺がんの検出を改善する新しい生検技術(New biopsy technique found to improve prostate cancer detection)")
Summary
Background
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.
Methods
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.
Findings
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.
Interpretation
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.
Funding
National Institute for Health and Care Research (NIHR) Health Technology Assessment.
