Durability of Functional Outcomes After MRI-Guided Transurethral Ultrasound Ablation of the Prostate

G. Hatiboglu, S. Nair, J. Relle, J. Hafron, Z. Kassam, K. Nandalur, M. Mueller-Wolf, D. Bonekamp, P. Doerwald, G. Clarke, H. Schlemmer, Matthias Roethke, S. Pahernik, Joseph L K Chin
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引用次数: 1

Abstract

Long-term data on functional outcomes after MRI-guided transurethral ultrasound ablation (TULSA) are limited. We assess the 5-year post-TULSA durability of outcomes for patient-reported genitourinary function, bowel function, and adverse events in 30 patients with primary, localized prostate cancer treated with TULSA across 3 centers. Patients received a conservative treatment plan in a phase 1 study designed to assess safety and feasibility. Follow-up visits took place at 1, 3, 6, 12 months, and biannually up to 5 years. Median (interquartile range) age at baseline was 69 (67-71) years. Erectile dysfunction (International Index of Erectile Function [IIEF] ≤17) was prevalent at baseline, with a mean (95% confidence interval [CI]) score of 16 (12-19), decreasing to 9 (4-14) at 5 years. At the 5-year visit, 71% of men who attempted intercourse in the recall period reported preservation of IIEF Q2 ≥2 erections sufficient for penetration. The mean (95% CI) International Prostate Symptom Score (IPSS) decreased from 9.0 (7.0-11) to 7.1 (5.0-9.1) from baseline to 5 years; IPSS-quality of life, maximum urinary flow rate, and post-void residual urine were stable or improved. Maintenance of bowel function and urinary continence was 100%. There was no new attributable serious or severe adverse event from 1 to 5 years. With a durably favorable safety profile, TULSA has the potential to treat cancer conservatively while simultaneously alleviating lower urinary tract symptoms. Data from larger studies are pending.
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mri引导下经尿道前列腺超声消融后功能结果的持久性
mri引导下经尿道超声消融(TULSA)后功能结果的长期数据是有限的。我们评估了3个中心的30例原发性局限性前列腺癌患者接受TULSA治疗后5年患者报告的泌尿生殖功能、肠道功能和不良事件的持久性。在一项旨在评估安全性和可行性的1期研究中,患者接受了保守治疗方案。随访时间分别为1个月、3个月、6个月、12个月和每半年,直至5年。基线年龄中位数(四分位数间距)为69岁(67-71岁)。勃起功能障碍(国际勃起功能指数[IIEF]≤17)在基线时普遍存在,平均(95%置信区间[CI])评分为16(12-19),5年后降至9(4-14)。在5年的随访中,71%在回忆期尝试性交的男性报告IIEF Q2≥2的勃起足以插入。平均(95% CI)国际前列腺症状评分(IPSS)从基线到5年从9.0(7.0-11)下降到7.1 (5.0-9.1);ipss的生活质量、最大尿流率和空后残余尿稳定或改善。肠道功能和尿失禁维持100%。1 ~ 5年内没有新的可归因的严重或严重不良事件。TULSA具有持久良好的安全性,具有保守治疗癌症的潜力,同时减轻下尿路症状。更大规模研究的数据尚未公布。
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