Abstract：
BACKGROUND: High-intensity focused ultrasound (HIFU) emerged as a novel approach for the treatment of localized prostate cancer (PCa). However, prospective studies on HIFU-related outcomes and predictors of treatment failure (TF) remain scarce.
METHODS: We conducted a multinational prospective cohort study among patients undergoing HIFU therapy for localized, low- to intermediate-risk PCa. Follow-up data on serial prostate specific antigen (PSA), multi-parametric magnetic resonance imaging (mpMRI), targeted/systematic biopsies, adverse events and functional outcomes were collected. The primary endpoint was TF, defined as histologically confirmed PCa requiring whole-gland salvage treatment. Uni- and multi-variable adjusted hazard ratios (HRs) were calculated using Cox proportional hazard regression models.
RESULTS: At baseline, mean (standard deviation) age was 64.14 (7.19) years, with the majority of patients showing T-stage 1 (73.9%) and International Society of Urological Pathology grading system Grade 2 (58.8%). PSA nadir (median, 1.70 ng/mL) was reached after 6 months. Of all patients recruited, 16% had clinically significant PCa, as confirmed by biopsy, of which 13.4% had TF. Notably, T-stage and number of positive cores at initial biopsy were independent predictors of TF during follow-up (HR [95% CI] 1.27 [1.02-1.59] and 5.02 [1.80-14.03], respectively). Adverse events were minimal (17% and 8% early and late adverse events, respectively), with stable or improved functional outcomes in the majority of patients.
CONCLUSIONS: This interim analysis of a multinational study on HIFU therapy for the management of low-to-intermediate-risk PCa reveals good functional outcomes, minimal adverse events and low incidence of TF over the short-term. Data on long-term outcomes, specifically as it relates to oncological outcomes, are awaited eagerly.
METHODS: We conducted a multinational prospective cohort study among patients undergoing HIFU therapy for localized, low- to intermediate-risk PCa. Follow-up data on serial prostate specific antigen (PSA), multi-parametric magnetic resonance imaging (mpMRI), targeted/systematic biopsies, adverse events and functional outcomes were collected. The primary endpoint was TF, defined as histologically confirmed PCa requiring whole-gland salvage treatment. Uni- and multi-variable adjusted hazard ratios (HRs) were calculated using Cox proportional hazard regression models.
RESULTS: At baseline, mean (standard deviation) age was 64.14 (7.19) years, with the majority of patients showing T-stage 1 (73.9%) and International Society of Urological Pathology grading system Grade 2 (58.8%). PSA nadir (median, 1.70 ng/mL) was reached after 6 months. Of all patients recruited, 16% had clinically significant PCa, as confirmed by biopsy, of which 13.4% had TF. Notably, T-stage and number of positive cores at initial biopsy were independent predictors of TF during follow-up (HR [95% CI] 1.27 [1.02-1.59] and 5.02 [1.80-14.03], respectively). Adverse events were minimal (17% and 8% early and late adverse events, respectively), with stable or improved functional outcomes in the majority of patients.
CONCLUSIONS: This interim analysis of a multinational study on HIFU therapy for the management of low-to-intermediate-risk PCa reveals good functional outcomes, minimal adverse events and low incidence of TF over the short-term. Data on long-term outcomes, specifically as it relates to oncological outcomes, are awaited eagerly.
摘要：
背景：高强度聚焦超声（HIFU）作为一种治疗局部前列腺癌（PCa）的新方法出现。然而,关于HIFU相关结局和治疗失败(TF)预测因素的前瞻性研究仍然很少.
方法：我们在接受HIFU治疗的患者中进行了一项多国前瞻性队列研究，低到中等风险的PCa。系列前列腺特异性抗原（PSA）的随访数据，多参数磁共振成像（MPMRI），靶向/系统活检，收集不良事件和功能结局.主要终点是TF，定义为需要全腺体抢救治疗的组织学证实的PCa。使用Cox比例风险回归模型计算单变量和多变量调整风险比（HR）。
结果：在基线时，平均（标准差）年龄为64.14（7.19）岁，大多数患者显示T阶段1（73.9％）和国际泌尿外科病理学学会分级系统2级（58.8％）。PSA最低点（中位数，6个月后达到1.70ng/mL）。在所有招募的患者中，16%有临床意义的PCa，经活检证实,其中13.4%有TF。值得注意的是,T分期和初始活检阳性核心数是随访期间TF的独立预测因子（HR[95%CI]1.27[1.02-1.59]和5.02[1.80-14.03]，分别)。不良事件极少（早期和晚期不良事件分别为17%和8%，分别)，大多数患者的功能结局稳定或改善。
结论：这项关于HIFU治疗低到中等风险PCa的跨国研究的中期分析揭示了良好的功能结果，短期不良事件最少，TF发生率低。关于长期结果的数据，特别是当它与肿瘤的结果有关时，热切地等待着。
方法：我们在接受HIFU治疗的患者中进行了一项多国前瞻性队列研究，低到中等风险的PCa。系列前列腺特异性抗原（PSA）的随访数据，多参数磁共振成像（MPMRI），靶向/系统活检，收集不良事件和功能结局.主要终点是TF，定义为需要全腺体抢救治疗的组织学证实的PCa。使用Cox比例风险回归模型计算单变量和多变量调整风险比（HR）。
结果：在基线时，平均（标准差）年龄为64.14（7.19）岁，大多数患者显示T阶段1（73.9％）和国际泌尿外科病理学学会分级系统2级（58.8％）。PSA最低点（中位数，6个月后达到1.70ng/mL）。在所有招募的患者中，16%有临床意义的PCa，经活检证实,其中13.4%有TF。值得注意的是,T分期和初始活检阳性核心数是随访期间TF的独立预测因子（HR[95%CI]1.27[1.02-1.59]和5.02[1.80-14.03]，分别)。不良事件极少（早期和晚期不良事件分别为17%和8%，分别)，大多数患者的功能结局稳定或改善。
结论：这项关于HIFU治疗低到中等风险PCa的跨国研究的中期分析揭示了良好的功能结果，短期不良事件最少，TF发生率低。关于长期结果的数据，特别是当它与肿瘤的结果有关时，热切地等待着。
