Clinical trial NCT05947188: Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(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
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Circulating Tumor Cells
multimodal MRI
Prostate Cancer
Diagnosis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Second Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Affiliated Hospital of Nantong University
name: Wujin People's Hospital
name: Seventh Medical Center of PLA Army General Hospital
name: The First Affiliated Hospital of Soochow University
First posted: 2023-07-17
Enrollment: 808
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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）.

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;

Primary outcomes:
measure: Positive predictive value of CTCs counts for prostate cancer
timeFrame: 12 weeks
Secondary outcomes:
measure: Correlation between CTCs counts and PIRADS score
timeFrame: 12 weeks
measure: combined PIRADS score for cancer and non-cancer
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: yang gao
role: STUDY_CHAIR
References: