NCT02022904撤回不适用
Development of a Novel Method to Detect Prostate Cancer Circulating Tumor Cells (CTCs) Based on Epithelial-mesenchymal Transition Biology
Duke University0 个研究点开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Non-detection rate of CTC's in men with CRPC
研究概览
简要总结
This is a minimal risk correlative clinical blood-drawing protocol. The objective of this lead in pilot component is to determine whether Circulating Tumor Cells (CTC's) can be captured using the novel mesenchymal-marker based Near Infrared-Emissive Polymersomes (NIR-EPs), the PSMA-based NIR-EP, and the epithelial EpCAM-based NIR-EP. If successful, the capture method will be evaluated further in the larger comparative study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •histologically confirmed diagnosis of adenocarcinoma of the prostate
- •Clinical or radiographic evidence of metastatic disease
- •Evidence of disease progression on androgen deprivation therapy (ADT) as evidenced by either of the following in the past:
- •Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week
- •Radiographic evidence of disease progression as defined by new bone scan lesions or soft tissue/visceral metastases >2 cm in diameter.
- •Clinical progression as determined by the treating physician.
- •Age greater than 18 years.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s)
结局指标
主要结局
Change in Non-detection rate of CTC's in men with CRPC
时间窗: at baseline, month 3, and progression (up to 18 months)
Non-detection rate of CTC's in men with CRPC will be measured at baseline, month 3, and at progression
次要结局
- Correlation of CTC enumeration with PSA kinetics(at baseline, month 3, and progression (up to 18 months))
- Correlation of CTC enumeration with therapies(at baseline, month 3, and progression (up to 18 months))
- Median number of CTC's detected by each capture method(baseline, month 3, and progression (up to 18 months))
- Change in median number of CTC's for each method(at baseline, month 3, and progression (up to 18 months))
- Correlation of CTC enumeration with presenting clinical stage(at baseline, month 3, and progression (up to 18 months))
- Correlation of CTC enumeration with sites of metastatic disease(at baseline, month 3, and progression (up to 18 months))
- Correlation of CTC enumeration with Gleason sum(at baseline, month 3, and progression (up to 18 months))
- Correlation of CTC enumeration with overall survival(at baseline, month 3, and progression (up to 18 months))
- Correlation of CTC enumeration with progression-free survival(at baseline, month 3, and progression (up to 18 months))
- Correlation of CTC enumeration with response to therapy(at baseline, month 3, and progression (up to 18 months))
研究者
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