Abstract：
OBJECTIVE: To assess histopathological outcomes, as well as feasibility and safety of targeted microwave ablation (TMA) via the Trinity® system (KOELIS, La Tronche, France).
METHODS: Prospective, 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.
RESULTS: The 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).
CONCLUSIONS: Targeted 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.
METHODS: Prospective, 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.
RESULTS: The 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).
CONCLUSIONS: Targeted 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.
摘要：
目的：评估组织病理学结果，以及通过Trinity®系统（KOELIS，LaTronche,法国)。
方法：前瞻性，单一机构，采用“消融切除”设计的介入IIa期研究。总之,11例诊断为局限性前列腺癌（PCa）的患者在门诊使用单直肠TATO®18-G天线和不同的治疗方案，在清醒镇静下通过三位一体系统接受了TMA。在TMA术后7天和1个月进行磁共振成像(MRI)和机器人辅助前列腺癌根治术(RARP),分别。9名患者接受了RARP,两名患者选择在TMA后撤回同意书。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积和坏死的确认。
结果：TMA已成功执行，所有患者均在同一天出院。在7天和1个月的随访中，未报告严重不良事件（不良事件的通用术语标准≥3级）。此外,在尿中没有观察到下降，性和射精功能结局。T1加权MRI显示清晰明确的消融区。RARP毫无困难地被执行,特别是在后平面的解剖过程中。因此,术中无并发症。手术标本的组织病理学评估证实没有活细胞，如果在TMA期间使用>10W的功率强度，则表明消融区完全坏死。消融区容积分析显示，在TMA（中位体积：2mL）和MRI（中位体积：1.923mL）的虚拟消融区的三维分割之间没有显着差异。相反，手术标本显著减少(中位体积:0.221mL).
结论：通过三位一体系统进行局部PCa治疗的靶向微波消融被证明是一种安全可行的方法，在手术标本的消融区内有完整的坏死证据。
方法：前瞻性，单一机构，采用“消融切除”设计的介入IIa期研究。总之,11例诊断为局限性前列腺癌（PCa）的患者在门诊使用单直肠TATO®18-G天线和不同的治疗方案，在清醒镇静下通过三位一体系统接受了TMA。在TMA术后7天和1个月进行磁共振成像(MRI)和机器人辅助前列腺癌根治术(RARP),分别。9名患者接受了RARP,两名患者选择在TMA后撤回同意书。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积和坏死的确认。
结果：TMA已成功执行，所有患者均在同一天出院。在7天和1个月的随访中，未报告严重不良事件（不良事件的通用术语标准≥3级）。此外,在尿中没有观察到下降，性和射精功能结局。T1加权MRI显示清晰明确的消融区。RARP毫无困难地被执行,特别是在后平面的解剖过程中。因此,术中无并发症。手术标本的组织病理学评估证实没有活细胞，如果在TMA期间使用>10W的功率强度，则表明消融区完全坏死。消融区容积分析显示，在TMA（中位体积：2mL）和MRI（中位体积：1.923mL）的虚拟消融区的三维分割之间没有显着差异。相反，手术标本显著减少(中位体积:0.221mL).
结论：通过三位一体系统进行局部PCa治疗的靶向微波消融被证明是一种安全可行的方法，在手术标本的消融区内有完整的坏死证据。
