A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 808
- 试验地点
- 1
- 主要终点
- Positive predictive value of CTCs counts for prostate cancer
研究概览
简要总结
This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.
详细描述
This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.
We will enroll 808 men with clinical suspicion of prostate cancer due to higher level PSA（>4ng/ml）or other examination abnormal. All the participants will receive prostate biopsy，the circulating tumor cells（CTCs）will be detected before biopsy.
This study will evaluate the diagnostic ability of CTCs+MRI and CTCs+MRI+PSA，including sensitivity, specificity, predictive values, diagnostic accuracy and receiver operating curves（ROC）.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •No family history of prostate cancer;
- •men ≥ 50 years；
- •tPSA level of 4-10 ng/ml, and fPSA/tPSA<0.16;
- •tPSA level of >10 ng/ml；
- •With abnomal mpMRI、PET/CT、TRUS or DRE;
- •fully understand the clinical trial protocol and sign the informed consent;
排除标准
- •Not meet all of the inclusion criteria or any single inclusion criteria；
- •previous diagnosis of prostate carcinoma ;
- •symptomatic of acute prostatitis;
- •local anesthetic allergy patients;
- •cannot tolerate prostate biopsy or has contraindication to biopsy;
- •patients judged by the investigator to be unsuitable to participate in the clinical trial;
结局指标
主要结局
Positive predictive value of CTCs counts for prostate cancer
时间窗: 12 weeks
Evaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology.
次要结局
- combined PIRADS score for cancer and non-cancer(12 weeks)
- Correlation between CTCs counts and PIRADS score(12 weeks)