ObjectiveTo assess histopathological outcomes, as well as feasibility and safety of targeted microwave ablation (TMA) via the Trinity® system (KOELIS, La Tronche, France).Patients and methodsProspective, single‐institution, interventional Phase IIa study with an ‘ablate‐and‐resect’ design. In all, 11 patients diagnosed with localised prostate cancer (PCa) underwent TMA via the Trinity system under conscious sedation in an outpatient setting using a single transrectal TATO® 18‐G antenna with different treatment regimens. Magnetic resonance imaging (MRI) and robot‐assisted radical prostatectomy (RARP) were conducted at 7 days and 1 month after TMA, respectively. Nine patients received RARP, and two patients chose to withdraw their consent following TMA. These men chose an active surveillance protocol upon confirmation of a low‐risk prostate cancer diagnosis. Functional outcomes and adverse events were evaluated at baseline and follow‐up visits using validated questionnaires. Prostate volumetry and confirmation of necrosis were carried out through MRI and whole‐mount histopathological examination.ResultsThe TMA was successfully executed, and all patients were discharged on the same day. No severe adverse events (Common Terminology Criteria for Adverse Events Grade ≥3) were reported at the 7‐day and 1‐month follow‐up visits. Additionally, no declines were observed in urinary, sexual and ejaculation functional outcomes. T1‐weighted MRI revealed clear and well‐defined ablation zones. The RARP was executed without difficulty, particularly during the dissection of the posterior plane. As a result, no intraoperative complications were encountered. Histopathological assessment on surgical specimens confirmed the absence of viable cells, indicating complete necrosis of the ablative zone if a power intensity >10 W was used during TMA. Ablation zone volumetry revealed no notable distinctions between the three‐dimensional segmentation of the virtual ablation zone at TMA (median volume: 2 mL) and MRI (median volume: 1.923 mL). Conversely, a significant reduction was noted in the surgical specimen (median volume: 0.221 mL).ConclusionsTargeted microwave ablation via the Trinity system for localised PCa treatment proves to be a secure and feasible procedure, with complete necrosis evidence within the ablation zone on surgical specimens.

中文翻译：

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前列腺癌靶向微波消融 (FOSTINE1b)：一项前瞻性“消融切除”研究

目的评估组织病理学结果，以及通过 Trinity® 系统（KOELIS，拉特龙什，法国）进行靶向微波消融 (TMA) 的可行性和安全性。患者和方法采用“消融和治疗”的前瞻性、单一机构、介入性 IIa 期研究‐切除'设计。总之，11 名诊断为局限性前列腺癌 (PCa) 的患者在门诊环境中在清醒镇静状态下通过 Trinity 系统接受了 TMA，使用单个经直肠 TATO® 18-G 天线和不同的治疗方案。分别在 TMA 后 7 天和 1 个月进行磁共振成像 (MRI) 和机器人辅助根治性前列腺切除术 (RARP)。九名患者接受了 RARP，两名患者在 TMA 后选择撤回同意。这些男性在确认低风险前列腺癌诊断后选择了主动监测方案。使用经过验证的问卷在基线和随访时评估功能结果和不良事件。通过MRI和整体组织病理学检查进行前列腺容量测定和坏死确认。结果TMA成功执行，所有患者当天出院。在 7 天和 1 个月的随访中未报告严重不良事件（不良事件通用术语标准≥3 级）。此外，未观察到泌尿、性和射精功能结果下降。 T1 加权 MRI 显示清晰且明确的消融区域。 RARP 的执行毫无困难，特别是在后平面的解剖过程中。结果，没有出现术中并发症。对手术标本的组织病理学评估证实不存在活细胞，表明如果在 TMA 期间使用 >10 W 的功率强度，则消融区域会完全坏死。消融区域体积分析显示，TMA（中位体积：2 mL）和 MRI（中位体积：1.923 mL）虚拟消融区域的三维分割之间没有显着差异。相反，手术标本显着减少（中位体积：0.221 mL）。 结论 通过 Trinity 系统进行靶向微波消融进行局部 PCa 治疗被证明是一种安全可行的手术，手术标本消融区内有完整的坏死证据。