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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 1700 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 10 sites (Chicago, Illinois and 9 other locations) |
| Status | Recruiting |
| Started | March 12, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT07492927 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
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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
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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
- Study coordinator: Jianhua Jiao, MD.
- Email: 1531769428@qq.com
- Phone: +86 029 84771062
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.