Prostate cancer
Conditions
Interventions
Gold Standard:Pathological Diagnosis of Prostate Biopsy
Index test:Urinary Exosomal PSMA-EVs
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 95 Years
Inclusion criteria
Inclusion criteria: 1. Male patients aged >=50 years; 2. Serum prostate-specific antigen (PSA) level between 4 and 20 ng/mL; 3. Underwent prostate MRI with findings interpreted as PI-RADS v2.1 score of 3; 4. Planned to undergo prostate biopsy; 5. Provided written informed consent and agreed to complete all study procedures.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed with prostate cancer or received any prior prostate treatment, such as surgery, radiotherapy, or hormonal therapy; 2. Presence of acute urinary tract infection or acute prostatitis; 3. Concurrent active malignancy in other organs; 4. Severe hepatic or renal dysfunction, or systemic diseases precluding tolerance to biopsy procedures; 5. Inability to provide a qualified urine sample; 6. Psychiatric or cognitive disorders that interfere with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC Value of PSMA-EVs for Diagnosing csPCa; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactLv Zhengtong
Beijing Hospital
Outcome results
None listed