A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Enrollment
- 808
- Locations
- 1
- Primary Endpoint
- Positive predictive value of CTCs counts for prostate cancer
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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）.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Positive predictive value of CTCs counts for prostate cancer
Time Frame: 12 weeks
Evaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology.
Secondary Outcomes
- combined PIRADS score for cancer and non-cancer(12 weeks)
- Correlation between CTCs counts and PIRADS score(12 weeks)