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

NCT05947188 | Unknown

• 1 other identifier: XJTU1AF2022LSL-010
• Study Type: interventional
• Target: 808
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Circulating Tumor Cells; multimodal MRI; Prostate Cancer; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between CTCs counts and PIRADS score

  12 weeks

• combined PIRADS score for cancer and non-cancer

  12 weeks

Study Arms (1)

Sample for Circulating Tumoral Cells

EXPERIMENTAL

Sampling of Circulating Tumoral Cells will be done

Other: prostate cancer diagnosis

Interventions

prostate cancer diagnosis OTHER

prostate cancer diagnosis

Sample for Circulating Tumoral Cells

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• yang gao

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

yang gao

CONTACT

0086-029-85323473; gaoyangxjtu@126.com

liang liang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 17, 2023
• Study Start: November 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)