Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
- 主要终点
- Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer
研究概览
简要总结
Multi-centre Randomized Clinical Trial: 106 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study.
Group 1: Focal ablation of the prostate at the side of the positive biopsies (focal-ablation) Group 2: Extended ablation of the prostate (extended ablation)
Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour.
Safety data will be collected and patients will be followed up at 1 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed organ-confined unilateral prostate cancer with adjacent positive biopsies on transperineal template prostate biopsies or MRI targeted biopsies in combination with systematic biopsies (clinical stage T1c-T2b)
- •Gleason sum score 6 or 7
- •PSA <15 ng/ml or PSA > 15 ng/mL counselled with caution
- •Life expectancy of > 10 years
排除标准
- •Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/uL
- •No ability to stop anticoagulant or anti-platelet therapy for 7 days prior the procedure.
- •Active urinary tract infection (UTI)
- •History of bladder neck contracture
- •Anaesthesia Surgical Assignment category IV or greater
- •History of inflammatory bowel disease
- •Concurrent major debilitating illness
- •Prior or concurrent malignancy except for basal cell carcinoma of the skin
- •Cardiac history including arrhythmias, ICD or pacemaker
- •Prostate calcifications greater than 5 mm.
- •Biologic or chemotherapy for prostate cancer
- •Hormonal therapy for prostate cancer within 6 months prior to procedure
- •Previous radiation to pelvis
- •Transurethral resection of the prostate / Urethral stent
- •Prior major rectal surgery (except haemorrhoids)
研究组 & 干预措施
Focal ablation
Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE
干预措施: Irreversible Electroporation (Nanoknife) (Device)
Extended ablation
Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE
干预措施: Irreversible Electroporation (Nanoknife) (Device)
结局指标
主要结局
Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer
时间窗: 5 years
To determine post procedural side-effects and Quality of life measured by International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P).
次要结局
- Oncological efficacy IRE ablation of prostate cancer.(5 years)