Does mpMRI guidance improve HIFU partial gland ablation compared to conventional ultrasound guidance? Early functional outcomes and complications from a single center

ABSTRACT Background Focal therapy (FT) for localized prostate cancer (PCa) treatment is raising interest. New technological mpMRI-US guided FT devices have never been compared with the previous generation of ultrasound-only guided devices. Materials and Methods We retrospectively analyzed prospectively recorded data of men undergoing FT for localized low- or intermediate-risk PCa with US- (Ablatherm®-2009 to 2014) or mpMRI-US (Focal One®-from 2014) guided HIFU. Follow-up visits and data were collected using internationally validated questionnaires at 1, 2, 3, 6 and 12 months. Results We included n=88 US-guided FT HIFU and n=52 mpMRI-US guided FT HIFU respectively. No major baseline differences were present except higher rates of Gleason 3+4 for the mpMRI-US group. No major differences were present in hospital stay (p=0.1), catheterization time (p=0.5) and complications (p=0.2) although these tended to be lower in the mpMRI-US group (6.8% versus 13.2% US FT group). At 3 months mpMRI-US guided HIFU had significantly lower urine leak (5.1% vs. 15.9%, p=0.04) and a lower drop in IIEF scores (2 vs. 4.2, p=0.07). Of those undergoing 12-months control biopsy in the mpMRI-US-guided HIFU group, 26% had residual cancer in the treated lobe. Conclusion HIFU FT guided by MRI-US fusion may allow improved functional outcomes and fewer complications compared to US- guided HIFU FT alone. Further analysis is needed to confirm benefits of mpMRI implementation at a longer follow-up and on a larger cohort of patients.

摘要
研究背景：针对局限性前列腺癌（prostate cancer, PCa）的局灶治疗（focal therapy, FT）正日益受到临床关注。目前，新型多参数磁共振成像-超声（multi-parametric magnetic resonance imaging-ultrasound, mpMRI-US）引导的局灶治疗设备，尚未与上一代仅超声引导的设备开展过头对头对比研究。
材料与方法：我们回顾性分析了前瞻性收集的、接受局灶治疗的局限性低危或中危前列腺癌患者的数据，这些患者分别采用仅超声引导（2009年至2014年使用Ablatherm®治疗仪）或mpMRI-US引导（2014年起使用Focal One®治疗仪）的高强度聚焦超声（high-intensity focused ultrasound, HIFU）治疗。分别于术后1、2、3、6及12个月，采用经过国际验证的调查问卷收集随访信息与相关数据。
结果：本研究共纳入88例仅超声引导局灶治疗HIFU患者与52例mpMRI-US引导局灶治疗HIFU患者。两组基线特征无显著差异，仅mpMRI-US组的格里森3+4评分患者占比更高。两组患者的住院时长（p=0.1）、导尿管留置时间（p=0.5）及并发症发生率（p=0.2）均无统计学差异，但mpMRI-US组的并发症发生率略低于仅超声引导组（6.8% vs 13.2%）。术后3个月时，mpMRI-US引导HIFU组的尿漏发生率显著更低（5.1% vs 15.9%，p=0.04），且国际勃起功能指数（International Index of Erectile Function, IIEF）评分下降幅度更小（2 vs 4.2，p=0.07）。mpMRI-US引导HIFU组中接受12个月随访活检的患者里，26%的患者治疗侧前列腺叶仍存在残留癌。
结论：与仅超声引导的HIFU局灶治疗相比，采用MRI-US融合引导的HIFU局灶治疗可获得更优的功能预后与更低的并发症发生率。未来仍需开展更长随访周期、更大样本量的队列研究，以验证mpMRI-US引导技术的临床获益。