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

February 1, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

808

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: liang liang

Study Locations

  • China
      • Xi'an, China
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sample for Circulating Tumoral Cells
Sampling of Circulating Tumoral Cells will be done
Other: prostate cancer diagnosis
prostate cancer diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Soochow University
Tianjin Medical University Second Hospital
Wujin People's Hospital
Affiliated Hospital of Nantong University
Seventh Medical Center of PLA Army General Hospital

Investigators

  • Study Chair: yang gao, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSL-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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