NCT02816983已完成不适用
A Phase II Evaluation of SBRT in Oligometastatic Castration-Refractory Prostate Cancer and Immunogenicity of SBRT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- PSA-progression free survival
研究概览
简要总结
Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA) are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions. Patients with <=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as definitive treatment. Blood draws will be taken to monitor the development of anti-prostate cancer immunity
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 must be receiving standard of care SBRT as outlined in the Universal Content Management (UCM) Procedure Manual (http://mayocontent.mayo.edu/radoncology/categories/index.html)
- •Age ≥ 18 years.
- •Metastatic castration-refractory prostate cancer patients with ≤ 3 lesions identified on standard imaging and/or choline PET/CT within 60 days of registration
- •Castrate levels of testosterone
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 (Appendix I).
- •Life expectancy > 6 months
排除标准
- •Emergent cord compression for spinal metastases
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
- •Transmural myocardial infarction within the last 6 months prior to registration
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
- •Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
- •HIV positive with Cluster Differentiation 4 (CD4) count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
- •End-stage renal disease (i.e., on dialysis or dialysis has been recommended).
- •Metastases located within 3 cm of the previously irradiated structures:
- •Spinal cord previously irradiated to > 40 Gy
- •Brachial plexus previously irradiated to > 50 Gy
- •Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
- •Brainstem previously irradiated to > 50 Gy
- •Lung previously irradiated with prior V20Gy > 30%
结局指标
主要结局
PSA-progression free survival
时间窗: 1 year
Overall Survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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