Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial

IF 25.2 1区医学 Q1 UROLOGY & NEPHROLOGY European urology Pub Date : 2024-12-04 DOI:10.1016/j.eururo.2024.11.006

Guillaume Ploussard , Patrick Coloby , Thierry Chevallier , Bob-Valéry Occéan , Nadine Houédé , Arnauld Villers , Pascal Rischmann , on behalf of the HIFI group

{"title":"Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial","authors":"Guillaume Ploussard , Patrick Coloby , Thierry Chevallier , Bob-Valéry Occéan , Nadine Houédé , Arnauld Villers , Pascal Rischmann , on behalf of the HIFI group","doi":"10.1016/j.eururo.2024.11.006","DOIUrl":null,"url":null,"abstract":"<div><h3>Background and objective</h3><div>High-intensity focused ultrasound (HIFU) has emerged as an interesting ablative alternative to radical prostatectomy (RP) and radiation therapy (RT) for localized prostate cancer (PC). However, no prospective comparative data have been published for HIFU.</div></div><div><h3>Methods</h3><div>We performed a prospective nonrandomized nationwide trial in 46 centers in France comparing RP versus HIFU. The main inclusion criterion was low- to intermediate-risk PC. The primary endpoint was salvage therapy–free survival (STFS). Secondary endpoints were metastasis-free survival, PC-specific survival, overall survival, and functional outcomes.</div></div><div><h3>Key findings and limitations</h3><div>From 2015 to 2019, 3328 patients were included (1967 HIFU and 1361 RP). Median age was 74.7 versus 65.1 yr (<em>p</em> < 0.001) and median PSA was 7.1 versus 6.9 ng/ml (<em>p</em> = 0.5) in the HIFU and RP groups, respectively. Intermediate-risk PC was diagnosed in 61% of patients in the HIFU group and 64% in the RP group (<em>p</em> = 0.10). The 30-mo STFS was not inferior in the HIFU group (hazard ratio 0.71, 95% confidence interval 0.52–0.97; <em>p</em> = 0.008). Some 10% of patients experienced urinary retention after HIFU. Grade >IIIa complications occurred in 54/1967 cases in the HIFU group and 29/1361 cases in the RP group (<em>p</em> = 0.3). In the HIFU group, fewer patients experienced a deterioration in 12-mo urinary continence (29% vs 44%) and the decrease in median International Index of Erectile Function-5 score was lower (difference −7 vs −13) in comparison to RP. Internal Prostate Symptom Scores and quality-of-life scores were comparable in the two groups. The main limitations are the lack of randomization and the age difference between the groups.</div></div><div><h3>Conclusions and clinical implications</h3><div>This large prospective trial demonstrates that whole-gland or subtotal HIFU provides comparable medium-term STFS outcomes to RP. Urinary continence and erectile function were less impaired after HIFU. These results should be interpreted with caution owing to the lack of randomization and the age difference between the groups. Future research should consider longer follow-up and evaluate focal treatments.</div><div>This trial is registered on ClinicalTrials.gov as NCT04307056.</div></div>","PeriodicalId":12223,"journal":{"name":"European urology","volume":"87 5","pages":"Pages 526-533"},"PeriodicalIF":25.2000,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European urology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0302283824027015","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background and objective

High-intensity focused ultrasound (HIFU) has emerged as an interesting ablative alternative to radical prostatectomy (RP) and radiation therapy (RT) for localized prostate cancer (PC). However, no prospective comparative data have been published for HIFU.

Methods

We performed a prospective nonrandomized nationwide trial in 46 centers in France comparing RP versus HIFU. The main inclusion criterion was low- to intermediate-risk PC. The primary endpoint was salvage therapy–free survival (STFS). Secondary endpoints were metastasis-free survival, PC-specific survival, overall survival, and functional outcomes.

Key findings and limitations

From 2015 to 2019, 3328 patients were included (1967 HIFU and 1361 RP). Median age was 74.7 versus 65.1 yr (p < 0.001) and median PSA was 7.1 versus 6.9 ng/ml (p = 0.5) in the HIFU and RP groups, respectively. Intermediate-risk PC was diagnosed in 61% of patients in the HIFU group and 64% in the RP group (p = 0.10). The 30-mo STFS was not inferior in the HIFU group (hazard ratio 0.71, 95% confidence interval 0.52–0.97; p = 0.008). Some 10% of patients experienced urinary retention after HIFU. Grade >IIIa complications occurred in 54/1967 cases in the HIFU group and 29/1361 cases in the RP group (p = 0.3). In the HIFU group, fewer patients experienced a deterioration in 12-mo urinary continence (29% vs 44%) and the decrease in median International Index of Erectile Function-5 score was lower (difference −7 vs −13) in comparison to RP. Internal Prostate Symptom Scores and quality-of-life scores were comparable in the two groups. The main limitations are the lack of randomization and the age difference between the groups.

Conclusions and clinical implications

This large prospective trial demonstrates that whole-gland or subtotal HIFU provides comparable medium-term STFS outcomes to RP. Urinary continence and erectile function were less impaired after HIFU. These results should be interpreted with caution owing to the lack of randomization and the age difference between the groups. Future research should consider longer follow-up and evaluate focal treatments.

This trial is registered on ClinicalTrials.gov as NCT04307056.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

全腺体或次全高强度聚焦超声与根治性前列腺切除术：前瞻性、非劣效性、非随机的HIFI试验

背景与目的高强度聚焦超声（HIFU）已成为根治性前列腺切除术（RP）和放射治疗（RT）治疗局限性前列腺癌（PC）的一种有趣的消融替代方法。然而，没有发表HIFU的前瞻性比较数据。方法我们在法国46个中心进行了一项前瞻性非随机全国试验，比较RP和HIFU。主要纳入标准为低至中危PC。主要终点是挽救性无治疗生存期（STFS）。次要终点为无转移生存期、pc特异性生存期、总生存期和功能结局。2015年至2019年，纳入3328例患者（1967例HIFU和1361例RP）。中位年龄分别为74.7岁和65.1岁(p <；0.001)， HIFU组和RP组中位PSA分别为7.1和6.9 ng/ml （p = 0.5）。HIFU组中有61%的患者诊断为中危性PC， RP组中有64% （p = 0.10）。HIFU组30月STFS并不差(风险比0.71,95%可信区间0.52-0.97；p = 0.008)。约10%的患者在HIFU后出现尿潴留。HIFU组出现IIIa级并发症54/1967例，RP组29/1361例（p = 0.3）。在HIFU组中，与RP相比，12个月尿失禁恶化的患者较少（29%对44%），国际勃起功能指数-5评分中位数下降更低（差异为- 7对- 13）。两组患者的内部前列腺症状评分和生活质量评分具有可比性。主要的限制是缺乏随机化和组间的年龄差异。结论和临床意义：这项大型前瞻性试验表明，全腺体或次全HIFU可提供与RP相当的中期STFS结果。HIFU后尿失禁和勃起功能受损程度较轻。由于缺乏随机化和各组之间的年龄差异，这些结果应谨慎解释。未来的研究应考虑更长时间的随访和评估局灶性治疗。该试验在ClinicalTrials.gov上注册为NCT04307056。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

European urology 医学-泌尿学与肾脏学

CiteScore

43.00

自引率

2.60%

发文量

1753

审稿时长

23 days

期刊介绍： European Urology is a peer-reviewed journal that publishes original articles and reviews on a broad spectrum of urological issues. Covering topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, the journal also highlights recent advances in techniques, instrumentation, surgery, and pediatric urology. This comprehensive approach provides readers with an in-depth guide to international developments in urology.