Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- G2+gastrointestinal and genitourinary toxicity at 2 years
研究概览
简要总结
MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.
详细描述
Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer.
Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.
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
- 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
- •indication for curative treatment
- •ECOG performance scale 0-2
- •Informed consent
排除标准
- •contraindications for curative treatment
- •age<18year
- •previous pelvic radiotherapy or prostatic treatment like TURP (transurethral resection of prostate), HIFU (high intensity focused ultrasound)
- •serious comorbidity leading to inability for IGRT (image-guided radiotherapy)
- •contraindications for MRI (Magnetic Resonance Imaging)
研究组 & 干预措施
Radiation
IGRT 5x 2Gy/week, total dose: 78 Gy
干预措施: IGRT (Radiation)
结局指标
主要结局
G2+gastrointestinal and genitourinary toxicity at 2 years
时间窗: Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint
Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 2 years
次要结局
- Long-term GU-GI toxicity(10 years after treatment)
研究者
Arndt-Christian Mueller
PD Dr. med.
University Hospital Tuebingen