Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer

March 19, 2026 updated by: Xijing Hospital
The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Xi'an, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • The First Hospital of Lanzhou University
        • Principal Investigator:
          • Wei Zhang, MD.
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Principal Investigator:
          • Zhiyong Lv, MD.
        • Contact:
    • Qinghai
      • Xining, Qinghai, China
        • Recruiting
        • Qinghai University Affiliated Hospital
        • Principal Investigator:
          • Guojun Chen, MD.
        • Contact:
    • Shaanxi
      • Weinan, Shaanxi, China
        • Recruiting
        • Weinan Central Hospital
        • Principal Investigator:
          • Weihong Zhao, MD.
        • Contact:
      • Xi'an, Shaanxi, China
        • Recruiting
        • Shaanxi provincial people's hospital
        • Principal Investigator:
          • Yi Sun, MD.
        • Contact:
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xijing 986 Hospital
        • Contact:
      • Xianyang, Shaanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Principal Investigator:
          • Wei Zheng, MD.
        • Contact:
      • Yan’an, Shaanxi, China
        • Recruiting
        • Yan'an University Affiliated Hospital
        • Principal Investigator:
          • Jixue Gao, MD.
        • Contact:
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Qiang Zhang, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The men with suspected prostate cancer

Description

Inclusion Criteria:

  1. Blood prostate-specific antigen PSA>4ng/dl;
  2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging.
  3. The patient is willing to undergo prostate biopsy.

Exclusion Criteria:

  1. Previous diagnosis of prostate cancer through prostate biopsy;
  2. History of other malignant tumors in the past two years;
  3. According to the research physician''s judgment, serious complications may occur and affect the normal conduct of the experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study Cohort
The experimental arm receiving diagnosis from serum RNA combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCa
Time Frame: The time of prostate biopsy

The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa.

Descriptive statistics were calculated and presented as the frequency (percentage) for categorical variables, the mean (standard deviation) for continuous variables with a normal distribution, and the median (quartile) for continuous variables with a skewed distribution. Two-sample t-tests were used to assess continuous variables with a normal distribution, and the Wilcoxon signed-rank test was used to assess continuous variables with a skewed distribution. The Mann-Whitney U test was used to compare means from two samples. The correlation between two samples was analyzed by Spearman's ρ test. The receiver operating characteristic (ROC) curve was used to determine the cutoff value of exo-RNA panel for diagnosing patients with csPCa.
The time of prostate biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa and its comparison with other imaging methods or blood tests
Time Frame: The time of prostate biopsy

The secondary outcome is to evaluate the positive predictive value (PPV), negative predictive value (NPV) and accuracy of exo-RNA panel in detection of csPCa; and compare the diagnostic performance of the plasma-exosome RNA panel with other imaging methods or blood tests in identifying prostate cancer patients; Whether the exo-RNA panel could predict the PCa patients with higher Gleason score (GS).

The comparison between diagnostic performance of exo-RNA panel and other imaging or blood tests is performed in ROC curves. The ICC analysis was performed by reliability analysis. All statistical analyses were conducted using IBM SPSS statistics software, version 23.0 (IBM, Inc., Chicago, IL, USA) and GraphPad Prism software, version 8.0 (GraphPad Software, Inc., La Jolla, CA, USA).
The time of prostate biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Northwestern University
LanZhou University
Qinghai University
Shaanxi Provincial People's Hospital
Air Force Military Medical University, China
Ningxia Medical University
Weinan Central Hospital
Yan'an University Affiliated Hospital
Shaanxi University of Chinese Medicine

Investigators

  • Study Chair: Weijun Qin, MD., Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • KY20262014-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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