Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are: Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists. Participants will: Receive combination of systematic biopsy and targeted biopsy.
• The age of the patient is between 45 and 85.
• Patients with complete multiparametric magnetic resonance imaging (mpMRI) data of Peking University First Hospital, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.
• 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 were in accordance with the indication of repeated prostate biopsy (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia, especially when the pathological results of multi-needle puncture were as above; re-examination of PSA \> 10 ng/ml; re-examination of PSA 4\
⁃ 10ng/ml, abnormal f/tPSA, abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results of re-examination of PSA 4\
⁃ 10ng/ml and with close follow-up, PSA for 2 consecutive years \> 10ng/ml or PSA volume \> 0.75/ml/ years). The time interval between the two prostate biopsies should be longer than three months.
• The targeted prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.
• Patients with complete clinical information.