CompletedNANCT06575361

Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study

Sponsor: Peking University First Hospital

Trial Details

ConditionProstate Cancer
InterventionCombination of targeted biopsy and systematic biopsy
PhaseNA
StatusCompleted
Participants365
Est. Completion30 June 2025
Last Updated6 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

China
View Registry Entry

This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service