Evaluation of the Effectiveness of Irreversible Electroporation for the Treatment of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 6-month oncological outcome
研究概览
简要总结
Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, Irreversible electroporation has evolved over the past decades and can be a reliable treatment option. Our study aims at assess the safety and effectiveness of such treatment in prostate cancer management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged between 40 - 85 years
- •Visible index lesion(s) on MRI
- •Found to have localized prostate cancer after MRI-USG fusion targeted biopsy or USG-guided template biopsy: Clinical tumour stage <=T2, or Gleason score <=7, or PSA <= 20 ng/ml
排除标准
- •Patients unfit for contrast MRI exam
- •Patients with active urinary tract infection
- •Patients with bladder pathology including bladder stone and bladder cancer
- •Patients with urethral stricture
- •Patients with neurogenic bladder and/or sphincter abnormalities
- •Patients who fail to give informed consent
研究组 & 干预措施
Prostate Irreversible Electroporation
干预措施: Prostate Irreversible Electroporation (Device)
结局指标
主要结局
6-month oncological outcome
时间窗: 6-month after treatment
6-month oncological outcome after Prostate Irreversible Electroporation treatment, as defined by multiparametric MRI result of prostate
次要结局
- 6-month and 12-month functional and oncological outcome(At 6-month and 12-month after treatment)
- 30-day complications(at 30 day after treatment)
- Presence of histologically proven prostate cancer recurrence(At 12-month after treatment)
- PSA change(At 3-month, 6-month, 9-month and 12-month after treatment)
研究者
Chi Hang Yee
Principal Investigator
Chinese University of Hong Kong