From the Departments of Adult Radiology (J.M.C., A.M.T., A.K.) and Histopathology (V.V., O.H.), Necker University Hospital, Paris, France; Department of Urology, Hôpital Européen Georges Pompidou, Paris, France (A.M.); Department of Urology, Northeastern Ohio Medical University, Youngstown, Ohio (R.M.); and Radiology Consultants, 250 DeBartolo Pl, Youngstown, OH 44512 (R.G.B.).
Radiology. 2015 Apr;275(1):280-9. doi: 10.1148/radiol.14140567. Epub 2014 Nov 19.
To prospectively evaluate the performance of real-time ultrasonographic (US) shear-wave elastography (SWE) in the diagnosis of peripheral zone prostate cancer in patients with high and/or increasing prostate-specific antigen levels and/or abnormal digital rectal examination results.
After signing an informed consent form, men referred for transrectal prostate biopsy were enrolled in this prospective HIPAA-compliant two-center study, which was conducted with institutional review board approval. Transrectal US SWE of the prostate was performed after a conventional transrectal US examination and immediately before US-guided 12-core sextant biopsy. For each sextant, the maximum SWE value was measured and matched to the pathologic results of that sextant biopsy. The diagnostic performance of SWE was assessed at both patient and sextant levels. The elasticity value maximizing the Youden index was used to derive sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
The elasticity values were matched to pathologic results for a total of 1040 peripheral zone sextants in 184 men. One hundred twenty-nine positive biopsy findings (size, ≥3 mm; Gleason score, ≥6) were identified in 68 patients. The sextant-level sensitivity, specificity, PPV, NPV, and area under the receiver operating characteristic curve for SWE with a cutoff of 35 kPa for differentiating benign from malignant lesions were 96% (95% confidence interval [CI]: 95%, 97%), 85% (95% CI: 83%, 87%), 48% (95% CI: 46%, 50%), 99% (95% CI: 98%, 100%), and 95% (95% CI: 93%, 97%), respectively.
Use of a 35-kPa threshold at SWE may provide additional information for the detection and biopsy guidance of prostate cancer, enabling a substantial reduction in the number of biopsies while ensuring that few peripheral zone adenocarcinomas are missed.
前瞻性评估实时超声剪切波弹性成像（SWE）在前列腺特异性抗原（PSA）水平升高和/或增加、或直肠指检异常的患者中诊断外周带前列腺癌的性能。
签署知情同意书后，入组本前瞻性符合 HIPAA 规定的双中心研究的患者接受经直肠前列腺超声检查，随后进行 SWE 检查，紧接着进行经直肠超声引导的 12 针前列腺外周带系统穿刺活检。每个 6 区的最大 SWE 值与相应的 6 区穿刺活检结果进行匹配。在患者和 6 区两个水平上评估 SWE 的诊断性能。采用最大 Youden 指数的弹性值来确定敏感度、特异度、阳性预测值（PPV）和阴性预测值（NPV）。
184 例患者共 1040 个外周带 6 区的弹性值与病理结果相匹配。在 68 例患者中发现 129 例阳性穿刺结果（大小，≥3mm；Gleason 评分，≥6）。SWE 以 35kPa 作为区分良恶性病变的截断值时，其在 6 区水平的敏感度、特异度、PPV、NPV 和受试者工作特征曲线下面积分别为 96%（95%置信区间：95%，97%）、85%（95%置信区间：83%，87%）、48%（95%置信区间：46%，50%）、99%（95%置信区间：98%，100%）和 95%（95%置信区间：93%，97%）。
SWE 采用 35kPa 阈值可能为前列腺癌的检测和活检提供额外信息，在确保较少遗漏外周带腺癌的同时，显著减少活检数量。
