The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0–72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3–82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.
PRESERVE研究（NCT04972097）旨在评估NanoKnife系统消融中危前列腺癌（PCa）患者前列腺组织的安全性和有效性。该系统通过不可逆电穿孔（IRE）技术释放高压电脉冲改变细胞膜通透性，从而诱导细胞死亡。研究共纳入121例器官局限性前列腺癌（分期≤T2c）、前列腺特异性抗原（PSA）≤15 ng/mL且格里森评分为3+4或4+3的患者，对其靶病灶进行局灶性消融。主要终点包括12个月内消融区域活检阴性结果及不良事件发生率、类型与严重程度。截至分析时，试验已完成入组并获初步随访数据。研究呈现了人口统计学特征、疾病特点、手术细节、PSA反应及不良事件（AEs）。筛查中位年龄（四分位距）为67.0（61.0-72.0）岁，格里森评分分布为3+4（80.2%）和4+3（19.8%）。6个月随访时，所有可获得数据的患者（n=74）PSA中位降幅（四分位距）达67.6%（52.3-82.2%）。仅10例（8.3%）出现3级不良事件，其中5例与手术相关。未报告≥4级不良事件。本研究验证了既往结论，即采用NanoKnife系统进行IRE前列腺消融具有安全性。最终结果有待进一步评估肿瘤学、功能学及安全性结局。
肿瘤(癌症)患者之家