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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05947188
Acronym
CMNDPC
Enrollment
808
Registered
2023-07-17
Start date
2023-11-01
Completion date
2024-12-31
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Circulating Tumor Cells, multimodal MRI, Prostate Cancer, Diagnosis

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）.

Interventions

OTHERprostate cancer diagnosis

prostate cancer diagnosis

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Positive predictive value of CTCs counts for prostate cancer12 weeksEvaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology.

Secondary

MeasureTime frameDescription
Correlation between CTCs counts and PIRADS score12 weeksDiagnostic value of CTCs
combined PIRADS score for cancer and non-cancer12 weeksDiagnostic value of CTCs

Countries

China

Contacts

Primary Contactyang gao
gaoyangxjtu@126.com0086-029-85323473
Backup Contactliang liang

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026