Prostate cancer
Conditions
Interventions
Gold Standard:Pathology of prostate
Index test:Multimodal Artificial Intelligence-AssistedDiagnostic Model for Prostate Cance
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 40 years, with suspected prostate cancer requiring imaging evaluation and/or biopsy evaluation; 2.Scheduled to complete prostate multiparametric MRI (mpMRI) and PSMA PET/CT examinations within 4 weeks after enrollment; 3.Expected to obtain pathological gold standard results (systematic biopsy and/or targeted biopsy and/or radical prostatectomy pathology); 4.Clinical data expected to be complete (including age, PSA, PI-RADS score, etc.); 5.Voluntary participation with signed informed consent;
Exclusion criteria
Exclusion criteria: 1.Imaging examinations cannot be completed as planned or image quality does not meet diagnostic requirements; 2.Prior prostate surgery (e.g., TURP), radical radiotherapy, or endocrine therapy; 3.Concurrent other pelvic malignancies; 4.Inability to understand the informed consent form or unwillingness to sign; 5.Other conditions deemed by the investigator as rendering the patient unsuitable for participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of the AI model for benign vs. malignant prostate cancer detection;Predictive performance of the AI model for ISUP Grade Group classification;Diagnostic performance of the AI model for clinically significant prostate cancer (csPCa) identification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical value of AI-assisted diagnosis in reducing unnecessary biopsies;Basic classification performance metrics of the AI model;Comparison of AI-assisted diagnosis vs. independent radiologist diagnosis; | — |
Countries
China
Contacts
Public ContactHuang Yuhua
The First Affiliated Hospital of Soochow University
Outcome results
None listed