Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.
研究概览
简要总结
The purpose of this phase II study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.
详细描述
This study will serve as a component of a larger program investigating the benefits of stereotactic radiotherapy in patients with metastatic disease.
This particular study will serve as a benchmark analysis.
All patients will receive stereotactic radiotherapy directed at metastatic tumors.
If primary prostate cancer is active and has not previously been treated with radiation therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended. The metastatic tumor will be treated at the same time.
Hormone therapy will be recommended for all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with metastatic cancer of the prostate,
- •Patients may have received prior surgery,
- •Prior radiation therapy, androgen deprivation therapy (ADT), immunotherapy, bone metastasis directed therapy, or chemotherapy for prostate cancer.
排除标准
- •End-stage heart disease,
- •End-stage liver disease,
- •End-stage renal disease,
- •End stage pulmonary disease
- •Current brain or central nervous system metastasis.
结局指标
主要结局
Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.
时间窗: 78 months after radiation treatment
Over the 78 month period, any occurrence of toxicity and/or treatment failure will be monitored via regular patient follow-up interviews. The cumulative rate at 78 months is analytic outcome of interest for each type of secondary outcome.
次要结局
- Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.(78 months after radiation treatment)
- Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer.(78 months after radiation treatment)
- Improvement in overall survival of patients with metastatic prostate cancer.(78 months after radiation treatment)