Development of a Prognostic Model for High Volume Metastatic Castration-Resistant Prostate Cancer Patients by Sequentially Analyzing the Expression of Molecular Markers in Circulating Tumor Cells
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a "liquid biopsy," these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients
- •18 yrs and older, and 80 yrs and younger
- •Histologically or cytologically proven prostate adenocarcinoma;
- •Imaging examinations including Emission Computed Tomography (ECT), Positron Emission Tomography (PET) and so on revealed a high-volume disease of patients(A high-volume of disease was defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis)
- •Have been received hormonal therapy and progressed into castration-resistant stage
- •Not yet receiving chemotherapy
- •Patients are willing to participate and can be followed up regularly
排除标准
- •Received the treatment of abiraterone acetate previously
- •Patients received chemotherapy previously
- •Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years).
结局指标
主要结局
overall survival
时间窗: 2 years
Overall survival was defined as the period of time from inclusion to death from any cause, or to the last follow up date.
次要结局
- time to prostate specific antigen (PSA) progression(2 years)
- time to radiographic progression(2 years)
- complete serologic response rate at 3 month and 6 month(1 year)
研究者
Bo Dai
Clinical Professor of Department of Urology
Fudan University