Background/Objectives: Whole-gland surgery or radiotherapy for localized prostate cancer (PCa) can cure the disease but often impair urinary and sexual function. Focal therapy with high-intensity focused ultrasound (HIFU) seeks to eradicate the tumor while sparing uninvolved tissue. We prospectively evaluated oncological control, functional outcomes and safety of MRI-guided focal HIFU in patients with low- or intermediate-risk PCa.Methods: In this prospective, single-arm, phase II feasibility trial (three Austrian centres, 2021–2024), treatment-naive patients with D’Amico low/intermediate-risk, PSA ≤ 15 ng/mL, clinical stage ≤ T2 and MRI-targeted, biopsy-confirmed index lesions underwent lesion-targeted HIFU (Focal One™). The primary endpoint was failure-free survival (FFS: absence of salvage whole-gland or systemic therapy, metastasis or PCa-specific death). Secondary endpoints included biopsy-proven cancer, prostate-specific antigen (PSA), patient-reported symptoms as International Prostate Symptom Score (IPSS), 5-item International Index of Erectile Function (IIEF), Gaudenz Incontinence Questionnaire and adverse events. Planned follow-up was 24 months with PSA every 3 months, mpMRI and biopsies at 12 months, and imaging- or PSA-triggered biopsies thereafter.Results: Fifty-one men were analysed in the per-protocol cohort (median age 67 years, median PSA 7.55 ng/mL). Median treated volume was 12 mL; median procedure time 85 min. At 24 months, FFS was 94.1%: 3/51 patients (5.9%) required salvage radiotherapy. Among 31 patients who underwent follow-up biopsy, 26 (83.9%) had no cancer; the five positives included three ISUP 1, one ISUP2 and one ISUP 4 lesion. Mean PSA fell by 69% at 3 months (to 2.3 ng/mL) and then stabilized under 3 ng/mL, with a mean of 2.7 ± 1.5 ng/mL at 24 months. Transient acute urinary retention occurred in 11/51 (21.6%); no Clavien–Dindo grade ≥ 4 events were reported. IPSS returned to or improved beyond baseline, erectile function largely recovered by 6–12 months, and only one new case of grade 2 incontinence was observed.Conclusions: MRI-guided focal HIFU achieved high two-year failure-free survival with low morbidity and preserved quality of life in carefully selected patients with low- or intermediate-risk PCa. These data support further randomized and longer-term investigations of focal HIFU as an organ-sparing alternative to whole-gland treatment.
背景/目的：针对局限性前列腺癌（PCa）的全腺体手术或放疗虽可治愈疾病，但常导致排尿与性功能受损。高强度聚焦超声（HIFU）局灶治疗旨在消除肿瘤的同时保留未受累组织。本研究前瞻性评估了MRI引导下局灶HIFU治疗对低危或中危PCa患者的肿瘤控制效果、功能结局及安全性。 方法：在这项前瞻性、单臂、II期可行性试验（2021–2024年，奥地利三个中心开展）中，纳入初治的D’Amico低/中危、PSA ≤ 15 ng/mL、临床分期 ≤ T2且经MRI靶向活检确认存在主导病灶的患者，接受病灶靶向HIFU治疗（Focal One™）。主要终点为无失败生存期（FFS：未接受挽救性全腺体治疗或全身治疗、无转移或PCa特异性死亡）。次要终点包括活检证实的癌症、前列腺特异性抗原（PSA）、患者报告症状（国际前列腺症状评分[IPSS]、5项国际勃起功能指数[IIEF]、Gaudenz尿失禁问卷）及不良事件。计划随访24个月，每3个月检测PSA，12个月时行多参数MRI及活检，后续根据影像学或PSA提示进行活检。 结果：符合方案集共分析51例男性患者（中位年龄67岁，中位PSA 7.55 ng/mL）。中位治疗体积为12 mL，中位手术时间85分钟。24个月时FFS为94.1%：3/51例患者（5.9%）需接受挽救性放疗。在31例完成随访活检的患者中，26例（83.9%）未检出癌症；5例阳性结果包括3例ISUP 1级、1例ISUP 2级和1例ISUP 4级病灶。平均PSA在3个月时下降69%（至2.3 ng/mL），随后稳定在3 ng/mL以下，24个月时平均值为2.7 ± 1.5 ng/mL。11/51例（21.6%）出现短暂性急性尿潴留；无Clavien–Dindo ≥ 4级事件报告。IPSS恢复至基线或更优水平，勃起功能在6–12个月内基本恢复，仅观察到1例新发2级尿失禁。 结论：在经严格筛选的低危或中危PCa患者中，MRI引导下局灶HIFU治疗实现了较高的两年无失败生存率，并发症发生率低，且生活质量得以保留。这些数据支持进一步开展随机对照及长期随访研究，以评估局灶HIFU作为全腺体治疗的器官保留替代方案的潜力。
肿瘤(癌症)患者之家