Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
Sponsor: Peking University First Hospital
Trial Details
| Condition | Prostate Cancer |
| Intervention | Combination of targeted biopsy and systematic biopsy |
| Phase | NA |
| Status | Completed |
| Participants | 365 |
| Est. Completion | 30 June 2025 |
| Last Updated | 6 May 2026 |
Primary Outcome
The clinically significant prostate cancer (csPCa) detection rate for suspicious lesions found by MRI-AI and urogenital radiologists; High-grade PCa detection rate
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * The age of the patient is between 45 and 85. * Patients with complete magnetic resonance imaging (MRI) data, qualified image quality control. * Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15. * Patients had no history of prior prostate surgery or biopsy. * The PSA of patients should be ≤20 ng/mL. * The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate MRI examination should not exceed one month. * Patients with complete clinical information. Exclusion Criteria: * The clinicopathological information and MRI data was unqualified or incomplete. * Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy. * Patients received prior prostate biopsy. * Patients had contraindications to MRI or prostate biopsy. * Patients were not in accordance with the indication of prostate biopsy.
Trial Sites
Countries
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