避免多参数前列腺 MRI 后不必要的活检：VERDICT 分析研究。
Avoiding Unnecessary Biopsy after Multiparametric Prostate MRI with VERDICT Analysis: The INNOVATE Study.
机构信息
From the Centre for Medical Imaging, Division of Medicine (S.S., H.R., J.C., E.W.J., T.P., D.A., S.P.), Centre for Medical Image Computing, Department of Medical Physics and Biomedical Engineering (B.K.), Molecular Diagnostics and Therapeutics Group (H.P., S.H., U.S.F., H.C.W.), Division of Surgery and Interventional Sciences (F.G., C.M.M.), and Centre for Medical Image Computing, Department of Computer Science (D.C.A., E.P.), University College London, Charles Bell House, 43-45 Foley St, London W1W 7TS, England; Department of Diagnostic Radiology, Royal Marsden Hospital, London, England (E.W.J.); Departments of Urology (A.G., E.D., G.S., C.M.M.), Pathology (A.H., A.F.), and Radiology (F.G.), University College London Hospitals NHS Foundation Trust, London, England; and Department of Urology, Barts Health, NHS Foundation Trust, London, England (A.G., G.S.).
出版信息
Radiology. 2022 Dec;305(3):623-630. doi: 10.1148/radiol.212536. Epub 2022 Aug 2.
Background In men suspected of having prostate cancer (PCa), up to 50% of men with positive multiparametric MRI (mpMRI) findings (Prostate Imaging Reporting and Data System [PI-RADS] or Likert score of 3 or higher) have no clinically significant (Gleason score ≤3+3, benign) biopsy findings. Vascular, Extracellular, and Restricted Diffusion for Cytometry in Tumor (VERDICT) MRI analysis could improve the stratification of positive mpMRI findings. Purpose To evaluate VERDICT MRI, mpMRI-derived apparent diffusion coefficient (ADC), and prostate-specific antigen density (PSAD) as determinants of clinically significant PCa (csPCa). Materials and Methods Between April 2016 and December 2019, men suspected of having PCa were prospectively recruited from two centers and underwent VERDICT MRI and mpMRI at one center before undergoing targeted biopsy. Biopsied lesion ADC, lesion-derived fractional intracellular volume (FIC), and PSAD were compared between men with csPCa and those without csPCa, using nonparametric tests subdivided by Likert scores. Area under the receiver operating characteristic curve (AUC) was calculated to test diagnostic performance. Results Among 303 biopsy-naive men, 165 study participants (mean age, 65 years ± 7 [SD]) underwent targeted biopsy; of these, 73 had csPCa. Median lesion FIC was higher in men with csPCa (FIC, 0.53) than in those without csPCa (FIC, 0.18) for Likert 3 ( = .002) and Likert 4 (0.60 vs 0.28, < .001) lesions. Median lesion ADC was lower for Likert 4 lesions with csPCa (0.86 × 10 mm/sec) compared with lesions without csPCa (1.12 × 10 mm/sec, = .03), but there was no evidence of a difference for Likert 3 lesions (0.97 × 10 mm/sec vs 1.20 × 10 mm/sec, = .09). PSAD also showed no difference for Likert 3 (0.17 ng/mL vs 0.12 ng/mL, = .07) or Likert 4 (0.14 ng/mL vs 0.12 ng/mL, = .47) lesions. The diagnostic performance of FIC (AUC, 0.96; 95% CI: 0.93, 1.00) was higher ( = .02) than that of ADC (AUC, 0.85; 95% CI: 0.79, 0.91) and PSAD (AUC, 0.74; 95% CI: 0.66, 0.82) for the presence of csPCa in biopsied lesions. Conclusion Lesion fractional intracellular volume enabled better classification of clinically significant prostate cancer than did apparent diffusion coefficient and prostate-specific antigen density. Clinical trial registration no. NCT02689271 © RSNA, 2022
背景 在疑似患有前列腺癌（PCa）的男性中，多达 50% 的多参数 MRI（前列腺成像报告和数据系统[PI-RADS]或 Likert 评分 3 或更高）阳性的男性在活检中没有发现具有临床意义的（Gleason 评分≤3+3，良性）病变。血管、细胞外和限制扩散用于肿瘤细胞分析（VERDICT）MRI 分析可以改善阳性 mpMRI 结果的分层。目的 评估 VERDICT MRI、mpMRI 衍生的表观扩散系数（ADC）和前列腺特异性抗原密度（PSAD）作为临床显著 PCa（csPCa）的决定因素。
材料和方法 2016 年 4 月至 2019 年 12 月，前瞻性招募了来自两个中心的疑似患有 PCa 的男性，并在其中一个中心进行 VERDICT MRI 和 mpMRI 检查，然后进行靶向活检。采用非参数检验，根据 Likert 评分将有和无 csPCa 的活检病变 ADC、病变衍生的细胞内分数（FIC）和 PSAD 进行比较。计算受试者工作特征曲线下面积（AUC）以测试诊断性能。
结果 在 303 名未经活检的男性中，165 名研究参与者（平均年龄 65 岁±7[SD]）接受了靶向活检；其中 73 人患有 csPCa。与无 csPCa 的病变相比，Likert 3（FIC，0.53）和 Likert 4（FIC，0.60）病变的有 csPCa 的病变的中位数 FIC 更高（ =.002）和 Likert 4（0.28，<.001）病变。与无 csPCa 的病变相比，Likert 4 病变的有 csPCa 的病变的 ADC 中位数较低（0.86×10mm/sec）（ =.03），但 Likert 3 病变无证据表明存在差异（0.97×10mm/sec 对 1.20×10mm/sec， =.09）。对于 Likert 3（0.17ng/mL 对 0.12ng/mL， =.07）或 Likert 4（0.14ng/mL 对 0.12ng/mL， =.47）病变，PSAD 也没有差异。FIC（AUC，0.96；95%CI：0.93，1.00）的诊断性能（AUC，0.96；95%CI：0.93，1.00）优于 ADC（AUC，0.85；95%CI：0.79，0.91）和 PSAD（AUC，0.74；95%CI：0.66，0.82），用于在活检病变中存在 csPCa。
结论 与 ADC 和 PSAD 相比，病变细胞内分数更能对具有临床意义的前列腺癌进行分类。
试验注册编号 NCT02689271 © RSNA，2022
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