挽救性不可逆电穿孔治疗放射性复发性前列腺癌——前瞻性 FIRE 试验。

Salvage irreversible electroporation for radio-recurrent prostate cancer - the prospective FIRE trial.

机构信息

Garvan Institute of Medical Research & The Kinghorn Cancer Centre, Darlinghurst, Sydney, New South Wales, Australia.

St. Vincent's Prostate Cancer Research Centre, Department of Urology, Darlinghurst, Sydney, New South Wales, Australia.

出版信息

BJU Int. 2023 Jun;131 Suppl 4:23-31. doi: 10.1111/bju.15947. Epub 2023 Jan 9.

DOI:10.1111/bju.15947

PMID:36495482

Abstract

OBJECTIVES

To prospectively assess the safety, functional- and oncological-outcomes of irreversible electroporation (IRE) as salvage therapy for radio-recurrent focal prostate cancer in a multicenter setting.

PATIENTS AND METHODS

Men with focal recurrent PCa after external beam radiation or brachytherapy without metastatic disease on staging imaging and co-registration between mpMRI and biopsies were prospectively included in this multicenter trial. Adverse events were reported following the Clavien-Dindo classification. Validated questionnaires were used for patient-reported functional outcomes. Follow-up consisted of 3 monthly prostate specific antigen (PSA) levels, a 6-month mpMRI and standardised transperineal template mapping biopsies at 12-months. Thereafter follow-up was guided by MRI and/or PSMA-PET/CT and PSA. Local recurrence was defined as any ISUP score ≥2 on biopsies.

RESULTS

37 patients were analysed with a median (interquartile range (IQR)) follow up of 29 (22-43) months. Median age was 71 (53-83), median PSA was 3.5 ng/mL (2.7-6.1). 28 (75.5%) patients harboured intermediate risk and 9 patients (24.5%) high risk PCa. Seven patients (19%) reported self-limiting urgency, frequency, or hematuria (grade 1-2). Seven patients (19%) developed a grade 3 AE; urethral sludge requiring transurethral resection. At 12 months post treatment 93% of patients remained continent and erectile function sufficient for intercourse deteriorated from 35% to 15% (4/27). Local control was achieved in 29 patients (78%) and 27 patients (73%) were clear of local and systemic disease. Four (11%) patients had local recurrence only. Six (16%) patients developed metastatic disease with a median time to metastasis of 8 months.

CONCLUSION

The FIRE trial shows that salvage IRE after failed radiation therapy for localised PCa is safe with minimal toxicity, and promising functional and oncological outcomes. Salvage IRE can offer a possible solution for notoriously difficult to manage radio recurrent prostate tumours.

摘要

目的

前瞻性评估不可逆电穿孔（IRE）作为局部复发性前列腺癌挽救性治疗的安全性、功能和肿瘤学结果，在多中心环境中。

方法

在外照射或近距离放射治疗后出现局灶性前列腺癌复发且分期影像学检查无转移疾病且 mpMRI 与活检的配准的男性患者前瞻性纳入这项多中心试验。不良事件按 Clavien-Dindo 分类报告。采用经过验证的问卷评估患者报告的功能结果。随访包括 3 个月一次的前列腺特异性抗原（PSA）水平、6 个月一次的 mpMRI 和 12 个月时的标准经会阴模板映射活检。此后，通过 MRI 和/或 PSMA-PET/CT 和 PSA 指导随访。局部复发定义为活检时任何 ISUP 评分≥2。

结果

分析了 37 例患者，中位（四分位距（IQR））随访时间为 29（22-43）个月。中位年龄为 71（53-83）岁，中位 PSA 为 3.5ng/mL（2.7-6.1）。28 例（75.5%）患者为中危 PCa，9 例（24.5%）为高危 PCa。7 例（19%）患者报告有自限性尿急、尿频或血尿（1-2 级）。7 例（19%）患者发生 3 级 AE；尿道积脓需要经尿道切除。治疗后 12 个月时，93%的患者保持控尿，性交时勃起功能充足的比例从 35%下降至 15%（4/27）。29 例（78%）患者达到局部控制，27 例（73%）患者达到局部和全身疾病无残留。4 例（11%）患者仅出现局部复发。6 例（16%）患者出现转移性疾病，中位转移时间为 8 个月。