NCT01726894Unknown不适用
A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer
University College London Hospitals2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety Profile
研究概览
简要总结
To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •* Histologically proven prostate cancer, Gleason Score \/= 10 years
- •* Signed informed consent by patient
- •* An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
排除标准
- •Men who have had previous radiation therapy
- •Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
- •Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- •Men with a non-visible tumour on mpMRI
- •Men with an inability to tolerate a transrectal ultrasound
- •Men with latex allergies
- •Men who have undergone prior significant rectal surgery preventing insertion of the TRUS probe (decided on the type of surgery in individual cases)
- •Men who have had previous IRE, HIFU, cryosurgery, thermal or microwave therapy to the prostate.
- •Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
- •Men not fit for major surgery as assessed by a Consultant Anaesthetist
- •Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
- •Presence of metal implants/stents in the urethra
- •Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
结局指标
主要结局
Safety Profile
时间窗: Up to 1 year
Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
次要结局
- Cancer Control(Six months)
- Sexual Side Effects(Up to 1 year)
- Continence side effect(Up to 1 year)
- Rectal side effects(Up to 1 year)
研究者
Professor Mark Emberton
Professor
University College London Hospitals
研究点 (2)
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