Prostate cancer
Conditions
Interventions
Gold Standard:Prostate pathology
Index test:PSMA PET/CT Five-Category Scoring System
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: Retrospective Modeling Phase 1. Age >= 45 years old; 2. Patients with pathologically confirmed prostate cancer or BPH; 3. Completion of PSMA PET/CT and prostate mpMRI examinations during the same period (interval <=3 months) before diagnosis; 4. Image quality meets diagnostic requirements; 5. Complete clinical pathology data available (including PSA, Gleason score, clinical stage, etc.); Prospective Validation Phase 1. Patients with clinical suspicion of prostate cancer or confirmed prostate cancer requiring staging/restaging; 2. Planned to undergo PSMA PET/CT and prostate mpMRI examinations during the same period (interval <=1 month); 3. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: Retrospective Modeling Phase 1. Poor image quality affecting interpretation; 2. Incomplete clinical or pathological data; 3. History of other active malignancies. Prospective Validation Phase 1. Contraindications to MRI or PET/CT examination; 2. Unable to cooperate to complete the examination; 3. Previous radical prostate treatment (such as prostatectomy, radical radiotherapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic Area Under the Receiver Operating Characteristic Curve (AUC) based on the pathological gold standard; | — |
Secondary
| Measure | Time frame |
|---|---|
| Negative Predictive Value;Positive Predictive Value;Diagnostic Specificity;Diagnostic Sensitivity;Diagnostic Accuracy;Inter-observer Agreement;Inter-system Agreement; | — |
Countries
China
Contacts
Public ContactHuang Yuhua
The First Affiliated Hospital of Soochow University
Outcome results
None listed