From the Division of Imaging Science and Technology, School of Medicine, University of Dundee, Dundee, UK, DD1 9SY (C.W., A.S.B., G.N.); Department of Clinical Radiology (M.S.B.), Department of Medical Physics (S.G.), and Department of Cellular Pathology (J.W.), Ninewells Hospital, Dundee, UK; Population Health and Genomics, School of Medicine (P.T.D.) and Tayside Clinical Trials Unit (P.R., K.C.), University of Dundee, Dundee, UK; Department of Clinical Radiology, Aberdeen Royal Infirmary, Aberdeen, UK (S.K.A.R.); Royal Free London NHS Foundation Trust, Royal Free Hospital, London, UK (P.S.); and Department of Clinical Radiology, NHS Fife, Kirkcaldy, UK (J.S.).
Radiology. 2023 Jul;308(1):e221428. doi: 10.1148/radiol.221428.
Background The optimal diagnostic pathway for prostate cancer (PCa) is evolving, requiring further evaluation in a randomized controlled trial. Purpose To assess the diagnostic accuracy of prebiopsy multiparametric MRI in the identification of clinically significant PCa (csPCa) using radical prostatectomy (RP) specimens as the reference standard, and to test the diagnostic accuracy of combined US and MRI fusion-targeted biopsy with systematic biopsies. Materials and Methods In a prospective randomized controlled trial including university hospitals, men with suspected PCa were recruited between January 2015 and August 2020 to assess the diagnostic accuracy of multiparametric MRI before biopsy in detection of csPCa at biopsy and RP histopathologic structure (primary outcome). Men with lesions suspicious for cancer (Prostate Imaging and Reporting Data System [PI-RADS] ≥3) at multiparametric MRI were first randomized to either systematic random prostate biopsies alone (control group) or US and MRI fusion-targeted biopsies with systematic random prostate biopsies (intervention group) at a one-to-one ratio to compare the diagnostic accuracy of systematic random versus combined fusion with systematic random biopsies (secondary outcome). A subset of recruited participants ( = 89) underwent RP and histologic sectioning. Results There were 582 participants who were eligible to undergo multiparametric MRI (mean age, 65 years ± 6 [SD]). In total, 413 had a PI-RADS score of at least 3 and were randomized into either the intervention group (207 of 413; 50.1%) or control group (206 of 413; 49.9%). The csPCa detection rate in the intervention group was higher, with an adjusted odds ratio of 1.79 (95% CI: 1.14, 2.79; = .01). A subgroup of 89 men underwent RP (21.5%; 89 of 413). Multiparametric MRI helped correctly identify 131 of 182 csPCa foci in 89 men (sensitivity, 72%; 95% CI: 65, 78). The specificity, positive predictive value, and negative predictive value were 71% (91 of 128), 78% (131 of 168), and 64% (91 of 142), respectively. Conclusion Prebiopsy multiparametric MRI was accurate in the depiction of clinically significant PCa. Combining US and MRI fusion-targeted biopsies with systematic biopsies helped detect more clinically significant lesions than did systematic biopsies alone. Clinical trial registration no. NCT02745496 © RSNA, 2023
背景 前列腺癌（PCa）的最佳诊断途径正在发展，需要在随机对照试验中进一步评估。目的 评估在经根治性前列腺切除术（RP）标本作为参考标准的情况下，前列腺癌前活检多参数 MRI 对临床显著前列腺癌（csPCa）的诊断准确性，并检验 US 和 MRI 融合靶向活检联合系统活检的诊断准确性。材料与方法 在一项包括大学医院的前瞻性随机对照试验中，招募了 2015 年 1 月至 2020 年 8 月期间疑似患有 PCa 的男性，以评估在活检前多参数 MRI 对活检和 RP 组织学结构中 csPCa 的诊断准确性（主要结局）。多参数 MRI 上有可疑癌症病变（前列腺成像和报告数据系统 [PI-RADS]≥3）的男性首先随机分为单纯系统随机前列腺活检（对照组）或 US 和 MRI 融合靶向活检联合系统随机前列腺活检（干预组），以 1:1 的比例比较系统随机与联合融合与系统随机活检的诊断准确性（次要结局）。招募的部分参与者（n=89）接受了 RP 和组织学切片。结果 共有 582 名符合条件的参与者接受了多参数 MRI（平均年龄 65 岁±6[标准差]）。共有 413 名患者的 PI-RADS 评分至少为 3，他们被随机分为干预组（413 名中的 207 名；50.1%）或对照组（413 名中的 206 名；49.9%）。干预组的 csPCa 检出率较高，调整后的优势比为 1.79（95%CI：1.14，2.79；P=.01）。89 名男性进行了 RP（21.5%；413 名中的 89 名）。多参数 MRI 有助于正确识别 89 名男性中 182 个 csPCa 病灶中的 131 个（敏感性，72%；95%CI：65，78）。特异性、阳性预测值和阴性预测值分别为 71%（128 个中的 91 个）、78%（168 个中的 131 个）和 64%（142 个中的 91 个）。结论 前列腺癌前多参数 MRI 能准确显示临床显著前列腺癌。与单纯系统活检相比，US 和 MRI 融合靶向活检联合系统活检有助于检出更多的临床显著病变。临床试验注册号 NCT02745496 ©RSNA，2023
