Prostate cancer
Conditions
Interventions
Gold Standard:Histopathological examination of specimens obtained from prostate biopsy or radical prostatectomy
Index test:Multimodal Artificial Intelligence Diagnostic Model
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The selection criteria for the discovery team include patients scheduled for prostate biopsy, as follows: (1) Suspicious nodules in the prostate detected by digital rectal examination (DRE); (2) Suspicious lesions identified by transrectal prostate ultrasound (TRUS) or MRI; (3) Serum PSA > 10 ng/ml; (4) Serum PSA 4-10 ng/ml, with fPSA/tPSA 0.15 (ng/mL/cm^3) or PSAV > 0.75 (ng/mL/year). 2. The selection criteria for the internal validation cohort and the external validation cohort are men with serum PSA < 4 ng/mL who are scheduled for prostate biopsy due to suspected lesions detected by DRE, TRUS, or MRI or for other reasons.
Exclusion criteria
Exclusion criteria: 1. The mpMRI examination was not completed or the mpMRI scan was incomplete or of poor quality; 2. The quality or quantity of cfDNA is insufficient for sequencing; 3. Key clinical or pathological data are missing; 4. The prostate biopsy was not completed and the subject could not be diagnosed; 5. Has a previous history of PCa or has received PCa treatment (including surgery, radiotherapy or androgen deprivation therapy); 6. Has a previous history of benign prostatic hyperplasia and is taking 5a-reductase inhibitors (such as finasteride), or has undergone prostate hyperplasia surgery (including TURP, thermal vaporization, prostate suspension, etc.); 7. Subjects considered not suitable to participate in this clinical trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;Specificity;Sensitivity; | — |
Countries
China
Contacts
Public ContactLu Yang
West China Hospital of Sichuan University
Outcome results
None listed