NCT01059513已完成不适用
Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- To quantify patient quality of life after prostate SBRT using validated questionnaire tools
研究概览
简要总结
This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of care for these patients and as such, is not an official component of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level <10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
- •The ability to understand and willingness to sign a written informed consent are necessary.
排除标准
- •Patients with tumor parameters that fall outside of the inclusion criteria.
- •Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.
- •Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).
- •A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.
- •The use of other concurrent investigational agents.
- •There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease.
- •No life expectancy restrictions will apply.
- •Performance status will not be considered.
结局指标
主要结局
To quantify patient quality of life after prostate SBRT using validated questionnaire tools
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (1)
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