愿景：一项个体患者数据荟萃分析，该分析涉及比较磁共振成像靶向活检与标准经直肠超声引导活检在前列腺癌检测中的随机试验。
VISION: An Individual Patient Data Meta-analysis of Randomised Trials Comparing Magnetic Resonance Imaging Targeted Biopsy with Standard Transrectal Ultrasound Guided Biopsy in the Detection of Prostate Cancer.
作者信息
Kasivisvanathan Veeru, Wai-Shun Chan Vinson, Clement Keiran D, Levis Brooke, Ng Alexander, Asif Aqua, Haider Masoom A, Emberton Mark, Pond Gregory R, Agarwal Ridhi, Scandrett Katie, Takwoingi Yemisi, Klotz Laurence, Moore Caroline M
机构信息
Division of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, University College London Hospitals Trust, London, UK.
Division of Surgery and Interventional Sciences, University College London, London, UK; Leeds Institute of Medical Research, University of Leeds, Leeds, UK.
出版信息
Eur Urol. 2025 May;87(5):512-523. doi: 10.1016/j.eururo.2024.08.022. Epub 2024 Sep 3.
BACKGROUND AND OBJECTIVE
The PRECISION and PRECISE trials compared magnetic resonance imaging targeted biopsy (MRI ± TB) with the standard transrectal ultrasound (TRUS) guided biopsy for the detection of clinically significant prostate cancer (csPCa). PRECISION demonstrated superiority of MRI ± TB over TRUS guided biopsy, while PRECISE demonstrated noninferiority. The VISION study is a planned individual patient data meta-analysis (IPDMA) comparing MRI ± TB with TRUS guided biopsy for csPCa diagnosis.
METHODS
MEDLINE, EMBASE, Web of Science, Cochrane Central of Registered Trials, and ClinicalTrials.gov were searched on the November 12, 2023 for randomised controlled trials of biopsy-naïve patients with a clinical suspicion of prostate cancer undergoing MRI or standard TRUS. Studies were included if its participants with suspicious MRI underwent targeted biopsy alone and those with nonsuspicious lesion avoided biopsy. The primary outcome is the proportion of men diagnosed with csPCa (Gleason ≥3 + 4).
KEY FINDINGS AND LIMITATIONS
Two studies, PRECISION and PRECISE (953 patients), were included in the IPDMA. In the MRI ± TB arm, 32.2% of patients avoided biopsy due to nonsuspicious MRI. MRI ± TB detected 8.7 percentage points (36.3% vs 27.6%; 95% confidence interval [CI] 2.8-14.6, p = 0.004) more csPCa than TRUS biopsy and 12.3 percentage points (9.6% vs 21.9%; 95% CI 7.8-16.9, p < 0.001) less clinically insignificant prostate cancer (cisPCa; Gleason 3 + 3). The overall risk of bias for the included studies were found to be low after assessment using the QUADAS-2, QUADAS-C, and ROB 2.0 tools.
CONCLUSIONS AND CLINICAL IMPLICATIONS
The MRI ± TB pathway is superior to TRUS biopsy in detecting csPCa and avoiding the diagnosis of cisPCa. MRI should be included in the standard of care pathway for prostate cancer diagnosis.
背景与目的
PRECISION和PRECISE试验比较了磁共振成像靶向活检（MRI±TB）与标准经直肠超声（TRUS）引导活检在检测临床显著性前列腺癌（csPCa）方面的效果。PRECISION试验表明MRI±TB优于TRUS引导活检，而PRECISE试验表明两者非劣效。VISION研究是一项计划中的个体患者数据荟萃分析（IPDMA），比较MRI±TB与TRUS引导活检在csPCa诊断中的效果。
方法
于2023年11月12日检索MEDLINE、EMBASE、科学网、Cochrane注册试验中心和ClinicalTrials.gov，查找临床怀疑前列腺癌且未进行过活检的患者接受MRI或标准TRUS检查的随机对照试验。如果研究中MRI可疑的参与者仅接受靶向活检，而MRI无异常的参与者避免活检，则纳入该研究。主要结局是诊断为csPCa（Gleason≥3 + 4）的男性比例。
主要发现与局限性
IPDMA纳入了两项研究，即PRECISION和PRECISE（953例患者）。在MRI±TB组中，32.2%的患者因MRI无异常而避免活检。与TRUS活检相比，MRI±TB检测出的csPCa多8.7个百分点（36.3%对27.6%；95%置信区间[CI] 2.8 - 14.6，p = 0.004），临床意义不显著的前列腺癌（cisPCa；Gleason 3 + 3）少12.3个百分点（9.6%对21.9%；95% CI 7.8 - 16.9，p < 0.001）。使用QUADAS - 2、QUADAS - C和ROB 2.0工具评估后发现，纳入研究的总体偏倚风险较低。
结论与临床意义
在检测csPCa和避免cisPCa诊断方面，MRI±TB途径优于TRUS活检。MRI应纳入前列腺癌诊断的标准治疗途径。
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