Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how artificial intelligence (AI) can help doctors more accurately diagnose prostate cancer using MRI scans. The researchers want to find out if AI can improve the detection of suspicious areas in the prostate, help calculate the size of the prostate, and predict the results of prostate biopsies, which are tests used to check for cancer. They will compare how well the AI performs against experienced radiologists, who are specialists in reading medical images.

To participate in this trial, men between the ages of 45 and 85 who have had a specific type of MRI scan showing potential issues with their prostate may be eligible. Participants will undergo two types of biopsies: a systematic biopsy that samples areas throughout the prostate and a targeted biopsy that focuses on the suspicious areas identified by the MRI. It’s important to note that participants should not have had previous treatments like surgery or radiation for prostate cancer before joining the study. This trial aims to enhance the understanding of how AI can support doctors in diagnosing prostate cancer, which could lead to better treatment options for patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • The mpMRI data was unqualified or incomplete.
• • Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
• • The mpMRI of Peking University First Hospital did not find suspicious prostate lesions.
• • Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy.