A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer Using Organ Based Tracking (OBT) Navigation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- The oncological control of prostate cancer
研究概览
简要总结
This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.
详细描述
This is a prospective multi-centre trial in 5 hospitals in 3 countries to investigate the efficacy and complications of targeted Microwave Ablation as a minimally invasive focal therapy for prostate cancer. Men aged 50-75 with PSA < 20ng/mL and clinically significant prostate cancer with 1-2 MRI lesions ≤15mm and ISUP grade group ≤3 will be recruited. Transperineal targeted Microwave Ablation of the prostate tumor(s) will be done with repeated ablations by a single microwave needle guided by MRI-Ultrasound fusion and organ-based tracking navigation. The primary outcome is any clinically significant prostate cancer detected on biopsy of treated area(s) per patient at 6 months.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged between 45 - 75 years
- •Life expectancy > 10 years upon recruitment
- •Able to understand the trial and can provide informed and written consent, dated and signed before the enrollment and before any exam required by the trial
- •Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
- •Organ-confined prostate cancer on MRI
- •PSA < 20 ng/mL
- •1-2 MRI visible lesion present and size ≤15mm, with targeted biopsy showing:
- •ISUP grade group 2 or 3, or
- •ISUP grade group 1 with tumor size ≥10mm
排除标准
- •Patients not fit for general or spinal anaesthesia
- •Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of <50 ml/min)
- •Patients with coagulopathy that cannot be corrected
- •Patients on anticoagulants or antiplatelets that cannot be stopped (Low dose Aspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMA treatment)
- •Patients with previous treatment of prostate cancer
- •Patients with prior pelvic radiotherapy for prostate cancer or other cancer
- •Patients with maximal length of target lesion >15mm
- •Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
- •. Patients with >2 areas (MRI-visible or invisible) of prostate cancer
- •Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
- •Patients with systematic cores showing any Gleason 4 pattern PCa which are not adjacent to the target lesions (1 core of pure Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable)
- •Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
- •Patients with bladder pathology including bladder stone and bladder cancer
- •Patients with known urethral stricture
- •Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.
研究组 & 干预措施
Targeted Microwave Ablation (TMA)
Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation
干预措施: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation (Device)
结局指标
主要结局
The oncological control of prostate cancer
时间窗: At 6 months after treatment
Any cancer detected on biopsy of each ablated area
次要结局
- Urinary Symptoms after treatment(At baseline, 3 Month, 6 Month and 12 Month)
- Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity(At baseline, 3 Month, 6 Month and 12 Month)
- Quality of life in patients with prostate cancer measured by EPIC-26(At baseline, 3 Month, 6 Month and 12 Month)
- Sexual side effects after treatment(At baseline, 3 Month, 6 Month and 12 Month)
- Continence side effects after treatment(At baseline, 3 Month, 6 Month and 12 Month)
- PSA change(At baseline, 3 Month and 6 Month and 12 Month)
- Common Terminology Criteria for Adverse Events (CTCAE) v5.0(At 3 Month, 6 Month and 1 year)
- Quality of life measured by QLQ-C30,(At baseline, 3 Month, 6 Month and 12 Month)
- Cancer detection on biopsy of each ablated MRI visible lesion(At 6 months after treatment)
- Cancer detection on biopsy of each ablated MRI invisible lesion(At 6 months after treatment)
- Gleason 4 or 5 cancer detected on biopsy of ablated area(At 6 months after treatment)
- Out-of-field recurrence: Any cancer outside treated area on systematic biopsy(At 6 months after treatment)
- Quality of life measured by ED-5Q-5Lquestionnaire(At baseline, 3 Month, 6 Month and 12 Month)
研究者
CHIU Ka Fung Peter
Professor
Chinese University of Hong Kong