LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Differences in acute adverse effects
研究概览
简要总结
The aim of this trial is to find out if there are any differences in the profiles of acute and late adverse effects among men with low and intermediate risk prostate cancer treated either with low dose-rate brachytherapy or hypofractionated external radiotherapy (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each treatment will be analysed.
详细描述
Prostate cancer (PC) is the most common solid malignancy among the men in the Western world. The classification to low, intermediate and high risk groups is determined by the PSA, Gleason score and clinical TNM status at the moment of diagnosis. There are several treatment options available for patients with low and intermediate risk PC and generally their prognosis is good. The men live long after their radical treatments and they have to live with the possible adverse effects caused by the treatment.
In this prospective, randomised clinical trial we are comparing two radiotherapy modalities to find out if there are differences in the acute and late adverse effects among men treated either by low dose-rate (LDR) brachytherapy or hypofractionated external radiotherapy. Also the PSA-responses and cost utilities will be analysed. The number of patients recruited for the study is 60 and the patients will be randomised 1:1 to each treatment arm.
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
- 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
- •biopsy proven adenocarcinoma of the prostate
- •Gleason score ≤ 3+4
- •clinical and radiological TNM T1c-2c, N0-X, M0-X, PSA ≤ 20ng/ml and WHO 0-2
- •low or intermediate risk prostate cancer according to National Comprehensive Cancer Network (NCCN) classification
排除标准
- •clinical TNM ≥ T3
- •Gleason score ≥ 4+3
- •high risk prostate cancer according to NCCN classification
- •history of cancer (other than PC) during the past 5 years (excluding basalioma and squamocellular carcinoma of the skin)
- •previous pelvic radiotherapy
- •previous active treatments of prostate cancer (active surveillance allowed)
- •bilateral hip prothesis or other implant impedes pelvic TT or MRI imaging
- •clopidogrel medication
- •poor co-operation
- •life expectancy < 5 yrs
结局指标
主要结局
Differences in acute adverse effects
时间窗: 6 months
questionnaires
次要结局
- Biological progression free survival (bPFS)(3 years)
- Time to PSA response(6 months)
- Time to PSA nadir(2 years)