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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: prostate cancer diagnosis

• Registration Number: NCT05947188
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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）.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-17
• Study Start: 2023-11-01
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-03
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 808

Inclusion Criteria

1. No family history of prostate cancer;
2. men ≥ 50 years；
3. tPSA level of 4-10 ng/ml, and fPSA/tPSA<0.16;
4. tPSA level of >10 ng/ml；
5. With abnomal mpMRI、PET/CT、TRUS or DRE;
6. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria

1. Not meet all of the inclusion criteria or any single inclusion criteria；
2. previous diagnosis of prostate carcinoma ;
3. symptomatic of acute prostatitis;
4. local anesthetic allergy patients;
5. cannot tolerate prostate biopsy or has contraindication to biopsy;
6. patients judged by the investigator to be unsuitable to participate in the clinical trial;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sample for Circulating Tumoral Cells	prostate cancer diagnosis	Sampling of Circulating Tumoral Cells will be done

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation between CTCs counts and PIRADS score	12 weeks	Diagnostic value of CTCs
combined PIRADS score for cancer and non-cancer	12 weeks	Diagnostic value of CTCs

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China