Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)

Study Overview
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Brief Summary
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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
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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）.

Official Title
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A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: prostate cancer diagnosis


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sample for Circulating Tumoral Cells<br>Sampling of Circulating Tumoral Cells will be done | Other: prostate cancer diagnosis<br>* prostate cancer diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of CTCs counts for prostate cancer | Evaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between CTCs counts and PIRADS score | Diagnostic value of CTCs | 12 weeks | 
| combined PIRADS score for cancer and non-cancer | Diagnostic value of CTCs | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, multimodal MRI, Circulating Tumor Cells, Diagnosis