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Trial Title:
Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)
NCT ID:
NCT05947188
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Neoplastic Cells, Circulating
Conditions: Keywords:
Circulating Tumor Cells
multimodal MRI
Prostate Cancer
Diagnosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
prostate cancer diagnosis
Description:
prostate cancer diagnosis
Arm group label:
Sample for Circulating Tumoral Cells
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）.
Criteria for eligibility:
Criteria:
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;
Gender:
Male
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
yang gao
Phone:
0086-029-85323473
Email:
gaoyangxjtu@126.com
Start date:
November 1, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Second Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Collaborator:
Agency:
Wujin People's Hospital
Agency class:
Other
Collaborator:
Agency:
Seventh Medical Center of PLA Army General Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05947188
