Prostate cancer
Conditions
Interventions
Gold Standard:Pathological Results of Prostate Biopsy
Index test:PSA,MRI,Urine Exosomes
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male individuals aged 60 or above; 2. The serum total PSA (tPSA) level is between 2.0 and 4.0 ng/ml, and the test result is the latest physical examination result. 3. Recently, there have been no oral medications such as finasteride or epiplate that affect PSA levels. 4. No history of prostatic puncture; 5. Agree to undergo urine sample collection, prostate MRI examination and biopsy if necessary, and sign the informed consent form; 6. Have the status of a permanent resident of a community in Beijing and be able to be followed up stably;
Exclusion criteria
Exclusion criteria: 1.Individuals with a previous clear diagnosis of prostate cancer; 2.History of recent prostate-related procedures (within the past 3 months) that may affect PSA levels, such as catheterization, cystoscopy, or digital rectal examination; 3.Active urinary tract infection or acute phase of prostatitis; 4.Severe underlying medical conditions, malignancy, or significant cognitive impairment that may interfere with compliance to the study procedures; 5.Contraindications to MRI examination, such as implanted cardiac pacemakers, metallic foreign bodies, or claustrophobia;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of prostate cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy analysis of the combined MRI and PSMA-EVs model;Biopsy positivity rate;MRI positivity rate;Diagnostic performance of PSMA-EVs testing;Incidence of newly diagnosed prostate cancer during follow-up;Proportion of clinically significant prostate cancer; | — |
Countries
China
Contacts
Public ContactLiu Ming
Beijing Hospital
Outcome results
None listed