Evaluation of the Effectiveness of Cryotherapy for the Treatment of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Oncological outcome-mpMRI prostate
研究概览
简要总结
This is a single-centre prospective, non-randomized trial to investigate the efficacy of cryotherapy in patients with localized prostate cancer.The aim of study is to investigate the safety profile of cryotherapy in the treatment of prostate cancer and to evaluate the oncological control of prostate cancer by means of cryotherapy focal treatment.
详细描述
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, cryotherapy is one of the most commonly employed energy sources. It exerts its effect through freezing of tissue and vascular injury, leading to destruction of cancer tissue. Our study aims at assess the safety and effectiveness of such treatment in prostate cancer management
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
- •Men aged between 40 - 85 years
- •Visible index lesion(s) on MRI
- •Found to have localized prostate cancer after MRI-USG fusion targeted biopsy:
- •Clinical tumour stage <= T2, or
- •Gleason score <= 7, or
- •PSA <= 20 ng/ml
排除标准
- •Patients unfit for contrast MRI exam
- •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
- •Patients who fail to give informed consent
结局指标
主要结局
Oncological outcome-mpMRI prostate
时间窗: 6 months
Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate
次要结局
- Functional outcome after cryotherapy(6 months and 12 months)
- Oncological outcome-Biopsy(12 months)
- Prostate Specific Antigen change(3 months, 6 months, 9 months, 12 months)
- Oncological Outcomes after cryotherapy(12 months)
- Complication after study intervention(30 days)
研究者
Chi Hang Yee
Honorary Associate Professor
Chinese University of Hong Kong