Prostate cancer
Conditions
Interventions
Gold Standard:Prostate needle biopsy pathology
Index test:1. Human PCA3 gene expression detection (urine sample, real-time quantitative PCR)
2. Non-invasive multivariate diagnostic model for prostate cancer based on PCA3 combined with clinical ind
Sponsors
The First Medical Center of Chinese People’s Liberation Army General Hospital
Eligibility
Sex/Gender
Male
Age
45 Years to 90 Years
Inclusion criteria
Inclusion criteria: Male patients aged 45 years or older who are scheduled to undergo prostate biopsy and have a PSA level between 4 and 20 ng/mL.
Exclusion criteria
Exclusion criteria: 1. Failure to complete prostate biopsy, resulting in the inability to obtain a definitive diagnosis; 2. Receipt of anti-androgen therapy within the past 12 months; 3. History of prostate cancer or prior prostate cancer–related surgery; 4. Any condition that, in the investigator’s judgment, makes the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the ROC curve (AUC) of a multivariate diagnostic model for diagnosing prostate cancer;Sensitivity of multivariate diagnostic models;Specificity of multivariate diagnostic models;Accuracy of multivariate diagnostic models; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic efficacy of PCA3 test under different PSA level stratification and MRI (PI-RADS) scoring stratification;Diagnostic performance of risk stratification models in distinguishing clinically significant prostate cancer (CSPCa) from non-clinically significant prostate cancer; | — |
Countries
China
Contacts
Public ContactShaoxi Niu
The First Medical Center of Chinese People’s Liberation Army General Hospital
Outcome results
None listed