Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 23
- 主要终点
- Number of patients without disease progression of prostate cancer treated by SBRT
研究概览
简要总结
This study aims to probe the effect of SBRT as a treatment oligometastases of prostate cancer, regardless of basal treatment received, and I know the response, biochemical control, the progression-free survival as well as their impact on quality of life.
Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated by SBRT.
Secondary Objectives: Analyzing biochemical progression rates, progression-free survival, chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of patients before and after treatment
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease.
- •Aged ≥ 18 years
- •Time to biochemical recurrence more than 1 year
- •PSA doubling time> 3 months
- •Less than 5 bone metastases location (including spinal) or lymph node.
- •Without other metastases or recurrences by Choline PET or / and NMR Diffusion Length.
- •Signed and dated written informed consent form.
排除标准
- •Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
- •Patients unwilling or unable to comply with protocol requirements and scheduled visits.
结局指标
主要结局
Number of patients without disease progression of prostate cancer treated by SBRT
时间窗: 5 years
Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage
次要结局
- Number of patients with an adverse events.(3 months after the SBRT treatment)
- Free disease progression survival measured with Kaplan-Meier method(the patients will be followed up an expected average of 5 years)
- Overall Survival measured with Kaplan-Meier method(patients will be followed up an average of 5 years)
- Quality of life questionnaire FACT-P(baseline and 3rd month after the SBRT treatment.)
研究者
Antonio J Conde Moreno
MD
Grupo de Investigación Clínica en Oncología Radioterapia