The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure
研究概览
简要总结
This trial is studying the effects and safety in treating patients with local prostate cancer with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new 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 Treatment Apparatus, may have the potential to conquer these disadvantages.
Purpose:
- This study will assess the efficacy of Composite Steep-pulse Treatment Apparatus in the treatment of PCa.
- This study will assess potency, urinary continence and complication rate for the patients undergo the treatment with steep pulse device.
- Histopathological analysis of prostate speciem 4 weeks after treated by Composite Steep-pulse Treatment Apparatus.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Prostate MRI can identify the suspect region(pi-RADS≥4 ) ,and no evidence of lymphatic metastasis
- •Patients must have confirmed prostate cancer by prostate biopsy
- •There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
- •No prostatic calculus or prostatic calculus≤5mm
- •No contraindication on total intravenous anesthesia
- •Not take any anticoagulants before or discontinue anticoagulant therapy at least 7 days
- •Age ≥ 30 - ≤ 75 years
- •Life expectancy of greater than 10 years
- •Patients scheduled for radical prostatectomy.
- •Sexually potent
排除标准
- •Patients have previously undergone radical prostatectomy.
- •Patients have previously undergone hormonal therapy or radiotherapy.
- •Patients underwent other surgery before less than 3 months
- •Clinically significant cardiovascular disease
- •Patients with other malignant tumor or patients with hiv.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with poor health condition
- •Simultaneous participation in another clinical trial
研究组 & 干预措施
Steep Pulse Device
Applying the steep pulse to treat the patients with Prostate cancer
干预措施: steep pulse device (Device)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure
时间窗: 1 Year
To determine if the IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
Efficacy (persentage of unablated tissue un the ablation zone)
时间窗: 1 month
Persentage of normal glandular tissue in the specified targeted ablation zone by histopathology assessment
次要结局
- Sexual function(1 month)
- Urinary incontinence(1 month)
研究者
yinghao Sun
director, head of uroglogy department, clinical professor
Second Military Medical University