Background

Irreversible electroporation (IRE) is a novel technique to treat localized prostate cancer with the aim of achieving oncological control while reducing related side effects. We present the outcomes of localized prostate cancer treated with IRE from a multi-center prospective registry.

Methods

Men with histologically confirmed prostate cancer were recruited to receive IRE. All the patients were proposed for prostate biopsy at 1-year post-IRE ablation. The functional outcomes were measured by the International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires. The safety of IRE was graded by the treatment-related adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE).

Results

411 patients were recruited in this study from July 2015 to April 2020. The median follow-up time was 24 months (IQR 15–36). 116 patients underwent repeat prostate biopsy during 12–18 months after IRE. Clinically significant prostate cancer (Gleason ≥ 3 + 4) was detected in 24.1% (28/116) of the patients; any grade prostate cancers were found in 59.5% (69/116) of the patients. The IPSS score increased significantly from 7.1 to 8.2 (p = 0.015) at 3 months but decreased to 6.1 at 6 months (p = 0.017). Afterwards, the IPSS level remained stable during follow-up. The IIEF-5 score decreased at 3 months from 16.0 to 12.1 (p < 0.001) and then maintained equable afterwards. The rate of AEs was 1.8% at 3 months and then dropped to less than 1% at 6 months and remained stable until 48 months after IRE. Major AEs (Grade 3 or above) were rare.

Conclusion

For men with localized prostate cancer, IRE could achieve good urinary and sexual function outcomes and a reasonable oncological result. The real-world data are consistent with earlier studies, including recently published randomized controlled studies. The long-term oncological results need further investigation and follow-up.

中文翻译：

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一项评估不可逆电穿孔消融前列腺癌的安全性、功能性和肿瘤学结果的多中心国际研究

背景

不可逆电穿孔（IRE）是一种治疗局限性前列腺癌的新技术，旨在实现肿瘤控制，同时减少相关副作用。我们展示了来自多中心前瞻性登记的 IRE 治疗局限性前列腺癌的结果。

方法

招募经组织学证实患有前列腺癌的男性接受 IRE 治疗。所有患者均建议在 IRE 消融后 1 年进行前列腺活检。功能结果通过国际前列腺症状评分（IPSS）和国际勃起功能指数（IIEF-5）调查问卷进行测量。IRE 的安全性根据不良事件通用术语标准 (CTCAE) 根据治疗相关不良事件 (AE) 进行分级。

结果

这项研究从 2015 年 7 月到 2020 年 4 月招募了 411 名患者。中位随访时间为 24 个月（IQR 15-36）。116 名患者在 IRE 后 12-18 个月内接受了重复前列腺活检。24.1% (28/116) 的患者检测出具有临床意义的前列腺癌（格里森≥ 3 + 4）；59.5% (69/116) 的患者发现任何级别的前列腺癌。IPSS 评分在 3 个月时从 7.1 显着增加至 8.2 ( p  = 0.015)，但在 6 个月时下降至 6.1 ( p  = 0.017)。此后随访期间IPSS水平保持稳定。IIEF-5 评分在 3 个月时从 16.0 下降至 12.1 ( p  < 0.001)，之后保持平稳。3 个月时 AE 发生率为 1.8%，6 个月时降至 1% 以下，并保持稳定直至 IRE 后 48 个月。主要 AE（3 级或以上）很少见。

结论

对于患有局限性前列腺癌的男性，IRE 可以获得良好的泌尿和性功能结果以及合理的肿瘤学结果。现实世界的数据与早期的研究一致，包括最近发表的随机对照研究。长期肿瘤学结果需要进一步调查和随访。