Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen [PSA] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age > or = 18 years
- •Pathological diagnosis of adenocarcinoma of the prostate
- •First or later line of chemotherapy
- •Serum testosterone < 50ng/mL
- •Serum PSA > or = 5ng/mL
- •PSA progression (2 rises above a reference value)
- •Bone scan within 60 days of enrollment
- •Computed tomography (CT) scan
- •If measurable disease, bone scans every 6-8 months
排除标准
- •Systemic radiation
- •Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
- •Brain metastases
结局指标
主要结局
Overall Survival
时间窗: Up to 36 months from time of baseline draw
次要结局
- Progression Free Survival(Up to 36 months after baseline draw)