HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
研究概览
简要总结
This is a phase II trial looking at the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy in non- metastatic prostate cancer
Endpoints:
Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy
Secondary endpoints
- Evaluating tumor response using HistoScanning
- Evaluating locoregional recurrence rates by measuring PSA
- Analysis of the correlation between tumor response as determined by HistoScanning and PSA response
- Evaluating the safety dose-painting image- guided interstitial brachytherapy by recording serious adverse events
详细描述
Rationale:
The study is designed as a prospective monocentric phase II trial. The choice of the therapeutic concept is governed by the risk group that the patient falls into. Risk groups are defined according to the classification by D' Amico.
The following concepts will be used:
HDR brachytherapy: 19,0- 38 Gy / 2-4 fractions (2-4 x 9,5 Gy)
PDR brachytherapy: 35-70 Gy / 50 --100 pulses(1 puls/h, 24 h/d)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically proven prostate cancer
- •All cT1-3 carcinomas independent of grading and PSA value
- •Prostate volume< 70cc
- •No distant metastases
- •Karnofsky > 60
- •Written informed consent from the patient regarding study participation
- •Exclusion criteria:
- •All patients who do not meet the inclusion criteria
- •T4 carcinomas
- •Proven metastases N+ and/or M1
- •Epidural or general anaesthesia not possible
- •Pathological clotting parameters
排除标准
- 未提供
结局指标
主要结局
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
时间窗: 5 years
次要结局
- assessing tumor response and side effects(5 years)