Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- bowel symptoms
研究概览
简要总结
Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.
详细描述
Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):
The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.
Hypothesis
Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.
Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.
Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of prostate
- •Signed study-specific consent
- •Prostate Specific Antigen (PSA) within 60 days of registration
排除标准
- •Prior pelvic radiotherapy
- •Prior radical prostate surgery
- •Medical or psychiatric illness that would interfere with treatment or follow up
- •Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery
结局指标
主要结局
bowel symptoms
时间窗: 24 months
Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
fatigue
时间窗: 2 years
Use questionnaire to assess patient's symptoms regarding fatigue
urinary symptoms
时间窗: 24 months
Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
sexual function
时间窗: 24 months
Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery
次要结局
- toxicity symptoms(24 months)
- cancer control(24 months)