Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Relationship between CTC quantity and pathologic stage
研究概览
简要总结
This study will evaluate a method to detect tumor cells that are circulating in the blood without getting a biopsy. The investigators already know from other studies that cancer tumors shed a small number of cells into the bloodstream every day. These are called circulating tumor cells (CTCs). Some early studies indicate the amount and type of CTCs in the blood can help determine the status of the tumor itself and the way it is responding to treatment. In this study, the investigators will compare the number of CTCs in the blood at different time frames before and after surgery to remove the prostate.
详细描述
The investigators will collect a blood sample for the study when the participant has other blood tests drawn for their cancer treatment. The investigators will take one sample to check prostate specific antigen (PSA) levels and another blood sample for CTC analysis. The investigators will be drawing blood at the following time points: Screening; One day after surgery; 7-14 days after surgery; 3-6 months after surgery; at PSA recurrence or at two years.
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
- •18 years of age or older
- •Pathologically confirmed diagnosis of prostate adenocarcinoma
- •Non-metastatic prostate cancer
- •Planned radical prostatectomy at Massachusetts General Hospital
排除标准
- •Patients must not have received prior radiation therapy, hormone therapy, or other medical therapy for prostate cancer prior to prostatectomy. Post-prostatectomy therapy at the discretion of the patient's treating physician(s) is allowed.
- •Patients must not have metastatic prostate cancer
- •No prior or current diagnosis of epithelial malignancy, except for skin cancer (squamous cell carcinoma or basal cell carcinoma)
结局指标
主要结局
Relationship between CTC quantity and pathologic stage
时间窗: Up to 2 weeks after prostatectomy
To evaluate the relationship between pre-operative CTC quantity and pathologic stage in men with early stage prostate cancer undergoing prostatectomy. Processing of the pathology specimen will require up to 2 weeks after surgery.
Persistent CTC and biochemical recurrence
时间窗: 2 year
To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer
次要结局
- Compare chromosome translocation status(2 years)
- Explore other uses of CTCs captured(10 years)
研究者
Richard J. Lee, MD
Assistant Physician
Massachusetts General Hospital