Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
研究概览
简要总结
- To elucidate the role of CTC detection in the evaluation of risk level in PCa patients, and establish a mathematic model for predicting the pathological status.
- To explore the possible subtle change in CTC condition after radical prostatectomy.
详细描述
- Detect and evaluate the CTC status (a total of 3 times: 1 day before sugery, 3/12 months after surgery) for all of the PCa patients enrolled. Analyze the CTC result with PSA level, needle biopsy and radiological imaging information.
- Analyze the difference in CTC amount/Epithelial-Mesenchymal ratio between patients in different D'Amico risk level(low/intermediate/high).
- Establish a mathematic model based on the CTC results and pathological condition observed in operation (OC, organ confined; EPE, extraprostatic extension; SVI, seminal vesicle invasion; LNI, lymph node invasion), and compare this model with the latest version of Partin table.
- Detect and compare the CTC and PSA level 3/12 months after surgery. Evaluate the radiological condition in 12 months after blood draw.
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
- •Diagnosed with PCa by biopsy, for the first time.
- •Clinical assessed suitable for radical prostatectomy
- •Age ≥ 18 years, able to provide written informed consent
- •No prior systematic or regional treatment for PCa.
- •No neuro-endocrine differentiation or small cell PCa pattern.
- •ECOG status 0-1
- •Expected life span ≥ 12 months.
- •Multiorgan function (heart, lung, liver, kidney) able to tolerate radical prostatectomy, and meet the standard of this study.
排除标准
- •Severe concomitant disease or infection.
- •ALT or AST > 2.5 ULN, or total bilirubin > 1.5 ULN; Creatinine >177umol/L(2.5mg/dL)；Plt < 100,000/uL, Neutrophil <1,500/uL.
- •Known or suspected brain metastasis or leptomeningeal carcinomatosis.
- •Another malignancy in the last 5 years, excluding completely cured melanoma.
- •Severe cardiovascular disease, including:
- •Myocardial infarct within 6 months; Uncontrolled angina pectoris within 3 months; Congestive heart failure; Ventricular arrhythmia history with clinical significance; Morbiz type Ⅱ or complete heart block
- •Major surgery (general anesthesia) within 4 weeks.
结局指标
主要结局
Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
时间窗: 1 day before operation
This step should be completed within the day when the peripheral venous blood is drawn.
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
时间窗: 12 months after operation
This step should be completed within the day when the peripheral venous blood is drawn.
Pathological findings (whether the patient has: 1.OC, organ confined; 2.EPE, extraprostatic extension; 3. SVI, seminal vesicle invasion; 4. LNI, lymph node invasion) during the radical prostectomy, confirmed by pathology section result
时间窗: On the day of operation
The pathology section evaluation will be done by two pathologists independently. A third pathology expert will join to make a final decision if opposite results are given by the two pathologists.
次要结局
- Prostate specific antigen (PSA) level measurement using peripheral venous blood(6 months after operation)
- PSA level measurement using peripheral venous blood(9 months after operation)
- Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan(12 months after operation)
研究者
Jun Qi
Head of the Urology Department
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine