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.

中文翻译：

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全腺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 HIFI 试验

 背景和目标

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） 的一种有趣的消融替代方法，用于治疗局限性前列腺癌 （PC）。然而，尚未发表 HIFU 的前瞻性比较数据。

 方法

我们在法国的 46 个中心进行了一项前瞻性非随机全国性试验，比较了 RP 与 HIFU。主要纳入标准是低至中等风险 PC。主要终点是挽救性治疗无生存期 （STFS）。次要终点是无转移生存期、 PC 特异性生存期、总生存期和功能结局。

主要发现和局限性

从 2015 年到 2019年，共纳入 3328 例患者 （1967 例 HIFU 和 1361 例 RP）。HIFU 和 RP 组的中位年龄分别为 74.7 岁和 65.1 岁 （p < 0.001），中位 PSA 分别为 7.1 和 6.9 ng/ml （p = 0.5）。HIFU 组 61% 的患者和 RP 组 64% 的患者被诊断为中等风险 PC （p = 0.10）。HIFU 组的 30 个月 STFS 并不劣势（风险比 0.71,95% 置信区间 0.52-0.97;p = 0.008）。约 10% 的患者在 HIFU 后出现尿潴留。HIFU 组 54/1967 例发生 >IIIa 级并发症，RP 组发生 29/1361 例 %（p = 0.3）。在 HIFU 组中，较少的患者经历 12 个月尿失禁恶化 （29% 对 44%），并且与 RP 相比，国际勃起功能指数 5 评分的中位下降较低 （差异 -7 vs -13）。两组的内部前列腺症状评分和生活质量评分相当。主要限制是缺乏随机性和组之间的年龄差异。

结论和临床意义

这项大型前瞻性试验表明，全腺或次全 HIFU 提供与 RP 相当的中期 STFS 结果。HIFU 后尿失禁和勃起功能受损较小。由于缺乏随机性和组间年龄差异，应谨慎解释这些结果。未来的研究应考虑更长的随访时间并评估局灶性治疗。此试用版在 ClinicalTrials.gov 上注册为 NCT04307056。