The Efficacy and Safety of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Apparatus Used in Prostate Cancer Ablation Therapy : a Multicenter, Single-arm, Objective Performance Criteria Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- The result of prostate maping biopsy
研究概览
简要总结
This trial is studying the effects and safety in treating patients from five different centers with local prostate cancer, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.
详细描述
Background:
Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus, may have the potential to conquer these disadvantages.
Purpose:
- This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus in the treatment of PCa.
- This study will assess the safety of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus in the treatment of PCa.
Methods:
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
- •The therapy must be thoroughtly understood with the agreement signed
- •Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis
- •Patients must have confirmed prostate cancer by prostate maping biopsy
- •Low-risk or intermediate risk prostate cancer(PSA<20ng/ml,T1a-T2c,Gleason Score≤7)
- •There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
- •No prostatic calculus or prostatic calculus≤5mm
- •Age ≥ 40 - ≤ 85 years
- •Life expectancy of greater than 5 years(WHO Performance Status 0-1)
- •Patients with fertility are willing to take contraceptive measures until the end of the trial
排除标准
- •Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy.
- •Patients underwent other surgery before less than 3 months.
- •Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months
- •Patients with clinically significant cardiovascular disease or other serious diseases
- •Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs.
- •Patients with history of epilepsy
- •Patients with other malignant tumor or patients with hiv.
- •Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial;
- •Patients with participation in another clinical trial less than 3 months.
- •Patients with the judge that they are not suitable for this clinical trial
结局指标
主要结局
The result of prostate maping biopsy
时间窗: 6 Months
evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer
The result of prostate MRI
时间窗: 6 Months
evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions
次要结局
- urinary incontinence(6 Months)
- sexual function (IIEF-5 scoring)(6 Months)
- urination function(IPSS scoring)(6 Months)
- urinary catheter retention time(6 Months)
研究者
yinghao Sun
director, head of uroglogy department, clinical professor
Second Military Medical University