search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prostate cancer diagnosis
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Circulating Tumor Cells, multimodal MRI, Prostate Cancer, Diagnosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Sample for Circulating Tumoral Cells

    Arm Description

    Sampling of Circulating Tumoral Cells will be done

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Correlation between CTCs counts and PIRADS score
    Diagnostic value of CTCs
    combined PIRADS score for cancer and non-cancer
    Diagnostic value of CTCs

    Full Information

    First Posted
    June 27, 2023
    Last Updated
    July 14, 2023
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
    Collaborators
    Tianjin Medical University Second Hospital, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nantong University, Wujin People's Hospital, Seventh Medical Center of PLA Army General Hospital, The First Affiliated Hospital of Soochow University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05947188
    Brief Title
    Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)
    Acronym
    CMNDPC
    Official Title
    A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 20, 2023 (Anticipated)
    Primary Completion Date
    September 20, 2023 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
    Collaborators
    Tianjin Medical University Second Hospital, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nantong University, Wujin People's Hospital, Seventh Medical Center of PLA Army General Hospital, The First Affiliated Hospital of Soochow University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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）.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Circulating Tumor Cells, multimodal MRI, Prostate Cancer, Diagnosis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    808 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sample for Circulating Tumoral Cells
    Arm Type
    Experimental
    Arm Description
    Sampling of Circulating Tumoral Cells will be done
    Intervention Type
    Other
    Intervention Name(s)
    prostate cancer diagnosis
    Intervention Description
    prostate cancer diagnosis
    Primary Outcome Measure Information:
    Title
    Positive predictive value of CTCs counts for prostate cancer
    Description
    Evaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Correlation between CTCs counts and PIRADS score
    Description
    Diagnostic value of CTCs
    Time Frame
    12 weeks
    Title
    combined PIRADS score for cancer and non-cancer
    Description
    Diagnostic value of CTCs
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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;

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs