Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Acute radiation - induced toxicity
研究概览
简要总结
The majority of all new prostate cancer cases are diagnosed in men aged > 70 years, with the highest incidence in men aged > 90 years. Management options for localized prostate cancer include active surveillance in patients with low-risk disease, radical prostatectomy or external beam radiation therapy.
In previous studies, hypofractionated prostate cancer irradiation regimens have been shown to represent a highly effective treatment option for prostate cancer. However, patients aged 75 years or older were underrepresented in most trials resulting in the lack of a robust evidence base.
The proposed study will evaluate radiation-induced toxicity as well as outcome after hypofractionated external beam radiotherapy in prostate cancer patients aged 75 years or older.
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
- 75 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed prostate cancer adenocarcinoma
- •definitive radiotherapy for curative intent
- •low or intermediate risk prostate cancer
- •patient age ≥ 75 years
- •given informed consent
排除标准
- •chronic inflammatory bowel disease
- •high risk prostate cancer
- •lymph node or distant metastases
- •unable to give informed consent
结局指标
主要结局
Acute radiation - induced toxicity
时间窗: Measurement 3 months after completion of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
次要结局
- Overall survival(At 1, 2, 3 , 4, 5 years after completion of radiotherapy)
- Recurrence (local)(At 1, 2, 3 , 4, 5 years after completion of radiotherapy)
- Recurrence (biochemical)(At 1, 2, 3 , 4, 5 years after completion of radiotherapy)