From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).
Radiology. 2021 Mar;298(3):695-703. doi: 10.1148/radiol.2021202717. Epub 2021 Feb 2.
Background To reduce adverse effects of whole-gland therapy, participants with localized clinically significant prostate cancer can undergo MRI-guided focal therapy. Purpose To explore safety and early oncologic and functional outcomes of targeted focal high-intensity focused ultrasound performed under MRI-guided focused ultrasound for intermediate-risk clinically significant prostate cancer. Materials and Methods In this prospective phase II trial, between February 2016 and July 2019, men with unifocal clinically significant prostate cancer visible at MRI were treated with transrectal MRI-guided focused ultrasound. The primary end point was the 5-month biopsy (last recorded in December 2019) with continuation to the 24-month follow-up projected to December 2021. Real-time ablation monitoring was performed with MR thermography. Nonperfused volume was measured at treatment completion. Periprocedural complications were recorded. Follow-up included International Prostate Symptom Score (IPSS) and International Index of Erectile Function-15 (IIEF-15) score at 6 weeks and 5 months, and multiparametric MRI and targeted biopsy of the treated area at 5 months. The generalized estimating equation model was used for statistical analysis, and the Holm method was used to adjust value. Results Treatment was successfully completed in all 44 men, 36 with grade group (GG) 2 and eight with GG 3 disease (median age, 67 years; interquartile range [IQR], 62-70 years). No major treatment-related adverse events occurred. Forty-one of 44 participants (93%; 95% CI: 82, 98) were free of clinically significant prostate cancer (≥6 mm GG 1 disease or any volume ≥GG 2 disease) at the treatment site at 5-month biopsy (median, seven cores). Median IIEF-15 and IPSS scores were similar at baseline and at 5 months (IIEF-15 score at baseline, 61 [IQR, 34-67] and at 5 months, 53 [IQR, 24-65.5], = .18; IPSS score at baseline, 3.5 [IQR, 1.8-7] and at 5 months, 6 [IQR, 2-7.3], = .43). Larger ablations (≥15 cm) compared with smaller ones were associated with a decline in IIEF-15 scores at 6 weeks (adjusted < .01) and at 5 months (adjusted = .07). Conclusion Targeted focal therapy of intermediate-risk prostate cancer performed with MRI-guided focused ultrasound ablation was safe and had encouraging early oncologic and functional outcomes. © RSNA, 2021 See also the editorial by Tempany-Afdhal in this issue.
背景 为减少全腺体治疗的不良反应，局限性临床显著前列腺癌患者可接受 MRI 引导下的局灶性治疗。目的 探讨 MRI 引导下聚焦超声局灶性治疗中高危局限性临床显著前列腺癌的安全性及早期肿瘤学和功能结局。
材料与方法 本前瞻性 2 期试验于 2016 年 2 月至 2019 年 7 月期间入组，单灶性 MRI 可见的局限性临床显著前列腺癌患者接受经直肠 MRI 引导下聚焦超声治疗。主要终点为 5 个月时（末次随访记录于 2019 年 12 月）的活检，随访预计持续至 2021 年 12 月的 24 个月。治疗过程中实时进行磁共振热成像消融监测，治疗结束时测量非灌注体积。记录围手术期并发症。随访包括治疗后 6 周和 5 个月的国际前列腺症状评分（IPSS）和国际勃起功能指数 15 分（IIEF-15）评分，以及治疗区域的多参数 MRI 和靶向活检。采用广义估计方程模型进行统计学分析，并采用 Holm 法校正 值。
结果 44 例患者均成功完成治疗，其中 36 例为 GG 2 级，8 例为 GG 3 级（中位年龄 67 岁；四分位距 [IQR]，6270 岁）。无与治疗相关的重大不良事件发生。44 例患者中，41 例（93%；95% CI：82，98）在治疗后 5 个月的活检时（中位活检 7 针）治疗部位无临床显著前列腺癌（≥6 mm GG 1 疾病或任何体积≥GG 2 疾病）。IIEF-15 和 IPSS 评分在基线和 5 个月时相似（基线时 IIEF-15 评分 61 [IQR，3467]，5 个月时 53 [IQR，2465.5]， =.18；基线时 IPSS 评分 3.5 [IQR，1.87]，5 个月时 6 [IQR，2~7.3]， =.43）。与较小消融范围（<15 cm）相比，较大消融范围（≥15 cm）与治疗后 6 周（校正 <.01）和 5 个月（校正 =.07）时 IIEF-15 评分下降相关。
结论 MRI 引导下聚焦超声消融治疗中高危局限性前列腺癌是安全的，且具有令人鼓舞的早期肿瘤学和功能结局。
