利用前列腺影像报告和数据系统（PI-RADS）评分选择最佳前列腺活检方法：Trio 研究的二次分析。
Using Prostate Imaging-Reporting and Data System (PI-RADS) Scores to Select an Optimal Prostate Biopsy Method: A Secondary Analysis of the Trio Study.
机构信息
Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
出版信息
Eur Urol Oncol. 2022 Apr;5(2):176-186. doi: 10.1016/j.euo.2021.03.004. Epub 2021 Apr 10.
BACKGROUND
While magnetic resonance imaging (MRI)-targeted biopsy (TBx) results in better prostate cancer (PCa) detection relative to systematic biopsy (SBx), the combination of both methods increases clinically significant PCa detection relative to either Bx method alone. However, combined Bx subjects patients to higher number of Bx cores and greater detection of clinically insignificant PCa.
OBJECTIVE
To determine if prebiopsy prostate MRI can identify men who could forgo combined Bx without a substantial risk of missing clinically significant PCa (csPC).
DESIGN, SETTING, AND PARTICIPANTS: Men with MRI-visible prostate lesions underwent combined TBx plus SBx.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary outcomes were detection rates for grade group (GG) ≥2 and GG ≥3 PCa by TBx and SBx, stratified by Prostate Imaging-Reporting and Data System (PI-RADS) score.
RESULTS AND LIMITATIONS
Among PI-RADS 5 cases, nearly all csPCs were detected by TBx, as adding SBx resulted in detection of only 2.5% more GG ≥2 cancers. Among PI-RADS 3-4 cases, however, SBx addition resulted in detection of substantially more csPCs than TBx alone (8% vs 7.5%). Conversely, TBx added little to detection of csPC among men with PI-RADS 2 lesions (2%) relative to SBx (7.8%).
CONCLUSIONS
While combined Bx increases the detection of csPC among men with MRI-visible prostate lesions, this benefit was largely restricted to PI-RADS 3-4 lesions. Using a strategy of TBx only for PI-RADS 5 and combined Bx only for PI-RADS 3-4 would avoid excess biopsies for men with PI-RADS 5 lesions while resulting in a low risk of missing csPC (1%).
PATIENT SUMMARY
Our study investigated an optimized strategy to diagnose aggressive prostate cancer in men with an abnormal prostate MRI (magnetic resonance imaging) scan while minimizing the risk of excess biopsies. We used a scoring system for MRI scan images called PI-RADS. The results show that MRI-targeted biopsies alone could be used for men with a PI-RADS score of 5, while men with a PI-RADS score of 3 or 4 would benefit from a combination of MRI-targeted biopsy and systematic biopsy. This trial is registered at ClinicalTrials.gov as NCT00102544.
背景
与系统活检（SBx）相比，磁共振成像（MRI）靶向活检（TBx）可更有效地检测前列腺癌（PCa），但两种方法的联合应用可使临床显著 PCa 的检出率高于任何一种单独的活检方法。然而，联合活检会导致更多的活检核心数，并增加对临床无意义 PCa 的检出。
目的
确定前列腺 MRI 检查能否识别出一些男性，如果不进行联合活检，他们错过临床显著 PCa（csPC）的风险不会显著增加。
设计、地点和参与者：MRI 可见前列腺病灶的男性接受了联合 TBx 和 SBx 检查。
观察指标和统计分析
主要观察指标为 TBx 和 SBx 对前列腺影像报告和数据系统（PI-RADS）评分的 GG≥2 和 GG≥3 PCa 的检出率，按 PI-RADS 评分分层。
结果和局限性
在 PI-RADS 5 病例中，几乎所有 csPC 都可通过 TBx 检出，而添加 SBx 仅导致 GG≥2 癌症的检出率增加 2.5%。然而，在 PI-RADS 3-4 病例中，与单独 TBx 相比，添加 SBx 可显著增加 csPC 的检出率（8% vs 7.5%）。相反，与 SBx（7.8%）相比，TBx 对 PI-RADS 2 病变（2%）的 csPC 检出率增加很少。
结论
尽管联合活检可增加 MRI 可见前列腺病灶男性的 csPC 检出率，但这种获益主要限于 PI-RADS 3-4 病变。对于 PI-RADS 5 病变，仅行 TBx 检查，对于 PI-RADS 3-4 病变，仅行联合活检，可避免对 PI-RADS 5 病变男性进行过多的活检，同时降低漏诊 csPC（1%）的风险。
患者总结
我们的研究旨在调查一种优化策略，以在最小化过度活检风险的同时，诊断出 MRI 异常的前列腺男性的侵袭性前列腺癌。我们使用了一种称为 PI-RADS 的 MRI 扫描图像评分系统。结果表明，PI-RADS 评分为 5 的男性可以仅行 MRI 靶向活检，而 PI-RADS 评分为 3 或 4 的男性则受益于 MRI 靶向活检和系统活检的联合应用。本试验在 ClinicalTrials.gov 注册，编号为 NCT00102544。
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