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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947188
• Other study ID #: XJTU1AF2022LSL-010
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: yang gao
• Phone: 0086-029-85323473
• Email: gaoyangxjtu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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）.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 808
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• prostate cancer diagnosis
prostate cancer diagnosis

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an

Sponsors (8)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	Correlation between CTCs counts and PIRADS score	Diagnostic value of CTCs	12 weeks
Secondary	combined PIRADS score for cancer and non-cancer	Diagnostic value of CTCs	12 weeks