Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Absence of Prostate Cancer on Biopsy
研究概览
简要总结
Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, high-intensity focused ultrasound (HIFU) is one of the most commonly employed energy sources. It exerts its effect through thermal and mechanical destruction of cancer tissue. This study aims at assess the effectiveness of such treatment in prostate cancer management.
In this study, investigators evaluate the early oncological outcome and objective functional outcome of patients undergoing HIFU for the treatment of localized intermediate risk prostate cancer.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Visible index lesion(s) on MRI
- •Index lesion(s) greater than 0.5 cm3
- •Found to have localized low-risk or intermediate-risk prostate cancer after MRI-USG fusion targeted biopsy and saturation biopsy:
- •Clinical tumour stage T2, or
- •Gleason score 7, or
- •PSA 20 ng/ml
排除标准
- •Prostate size larger than 50 ml
- •Patients unfit for contrast MRI exam
- •Patients with previous treatment of prostate cancer
- •Patients with previous surgery on the prostate
- •Patients with active urinary tract infection
- •Patients with bladder pathology including bladder stone and bladder cancer
- •Patients with urethral stricture
- •Patients with neurogenic bladder and/or sphincter abnormalities
- •Fail to give informed consent
结局指标
主要结局
Absence of Prostate Cancer on Biopsy
时间窗: 3 months
Oncological outcome 1: percentage in absence of prostate cancer on biopsy
次要结局
- Presence of Significant Prostate Cancer(3 months)
- Change in Prostate specific antigen (PSA)(3 months and 6 months)
- Change in Urodynamic(3 months and 6 months)
- Change in Prostate Symptom Score(3 months and 6 months)
- Change in Urinating Symptom Score(3 months and 6 months)
- Pain score(Post treatment (day 1))
研究者
Chi Hang Yee
Honorary Associate Professor
Chinese University of Hong Kong