NCT02723526Unknown不适用
Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- time to castration-resistant prostate cancer
研究概览
简要总结
As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.
研究设计
- 研究类型
- Observational
- 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),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
- •Not yet receiving hormonal therapy;
- •Not yet receiving chemotherapy previously;
- •Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
- •Patients are willing to participate and can be followed up regularly；
排除标准
- •Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
- •Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
- •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
time to castration-resistant prostate cancer
时间窗: 3 years
次要结局
- complete serologic response rate at 6 month and 12 month(1 years)
- time to prostate specific antigen (PSA) progression(3 years)
- time to prostate specific antigen (PSA) nadir(2 years)
- time to radiographic progression(3 years)
研究者
Bo Dai
Clinical Professor of Department of Urology
Fudan University
研究点 (1)
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