Clinical trial Recruiting at 10 sites Observational Ages 18 and up Men only

Blood exosomal RNA test to diagnose clinically significant prostate cancer

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

Run by Xijing Hospital · NCT07492927 · Data updated 2026-11-12

This study will test whether a blood-based exosome RNA signature can detect clinically significant prostate cancer in men with elevated PSA and suspicion for cancer.

More Clinically Significant Prostate Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment1700 (estimated)
SponsorXijing Hospital
Academic / other
Locations10 sites (Chicago, Illinois and 9 other locations)
StatusRecruiting
StartedMarch 12, 2021
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedMarch 25, 2026
Trial IDNCT07492927 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men with a PSA above 4 and clinical or imaging findings that raise suspicion for prostate cancer who are willing to have a prostate biopsy are ideal candidates.

Probably not a fit

Men with a prior prostate cancer diagnosis, a recent other malignancy within the past two years, or significant medical issues that would interfere with study procedures are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, multi-center study collecting blood from men suspected of having prostate cancer to measure a plasma exosome RNA signature. Participants will generally have elevated PSA or suspicious findings on exam or imaging and must be willing to undergo prostate biopsy. Researchers will compare the RNA signature results to biopsy outcomes to determine how well the blood test identifies clinically significant cancer. No investigational treatments are given; the study uses blood samples and standard diagnostic procedures across participating hospitals.

Why it matters

Potential benefit: If successful, the test could help identify men with clinically important prostate cancer from a simple blood draw and reduce unnecessary biopsies.

How similar studies have gone: Related liquid-biopsy and exosome RNA approaches have shown promising early results but remain emerging and are not yet standard clinical practice.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Northwestern Memorial Hospital
    Chicago, Illinois, United States
    Recruiting
  • The First Hospital of Lanzhou University
    Lanzhou, Gansu, China
    Recruiting
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia, China
    Recruiting
  • Qinghai University Affiliated Hospital
    Xining, Qinghai, China
    Recruiting
  • Weinan Central Hospital
    Weinan, Shaanxi, China
    Recruiting
  • Shaanxi Provincial People's Hospital
    Xi'an, Shaanxi, China
    Recruiting
Show 4 more locations
  • Xijing 986 Hospital
    Xi'an, Shaanxi, China
    Recruiting
  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
    Xianyang, Shaanxi, China
    Recruiting
  • Yan'an University Affiliated Hospital
    Yan’an, Shaanxi, China
    Recruiting
  • Xijing Hospital
    Xi'an, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.