Blood exosomal RNA test to diagnose clinically significant prostate cancer

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

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
• Enrollment: 1700 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 10 sites (Chicago, Illinois and 9 other locations)
• Trial ID: NCT07492927 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

Chicago, Illinois and 9 other locations

• 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)
• 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.

Conditions Clinically Significant Prostate Cancer