Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- PSA level
研究概览
简要总结
The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer.
Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
详细描述
Detailed Description:
Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.
Moreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally.
This study is a prospective and non-randomized with one group of 12 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol).
Before the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci.
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
- •Verified with MR-fusion biopsy localized Pca
- •PSA < 20 ng/ml
- •Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2
- •Life expectancy > 10 years
- •No post-void residual urine or infravesical obstruction
排除标准
- •patients with artificial cardiac pacemaker
- •patients not eligible for general anesthesia
- •patients after primary Pca treatment
- •hormonal therapy six months before the study
- •radiotherapy of pelvic organs
- •urinary infection
- •extracapsular Pca
- •patients with metastatic lesions
结局指标
主要结局
PSA level
时间窗: 3 months, 6 months, 9 months, 12 months
Stable decrease of PSA level after surgery (\<1 ng/ml)
Complications
时间窗: 1 year
Short and long term surgical complications according to Clavien-Dindo
次要结局
- IIEF(1 year)
- QoL (Quality of Life score, range 1-6)(1 year)
- Qmax(1 year)
- IPSS (International Prostate Symptom Score, range from 5 to 30(1 year)
研究者
Dmitry Enikeev, MD, PhD
Deputy Director for Research
I.M. Sechenov First Moscow State Medical University