Evaluating MRI-AI for diagnosing prostate cancer
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
This study is testing if using artificial intelligence with MRI scans can help doctors find prostate cancer more accurately than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | Male |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06575361 on ClinicalTrials.gov |
What this trial studies
This prospective diagnostic study aims to assess the effectiveness of MRI artificial intelligence (MRI-AI) in diagnosing prostate cancer. It will compare the cancer detection rates of suspicious lesions identified by MRI-AI with those detected by experienced radiologists. Participants will undergo a combination of systematic and targeted biopsies, with the study focusing on the AI's ability to accurately calculate prostate volume and predict biopsy results. The research seeks to enhance diagnostic accuracy and reduce inconsistencies in prostate cancer detection.
Who should consider this trial
Good fit: Ideal candidates are men aged 45 to 85 with suspicious lesions detected through imaging and indications for prostate biopsy.
Not a fit: Patients without suspicious lesions or those who do not meet the biopsy criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of prostate cancer, improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results with AI in prostate cancer detection, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yi LIU — Peking University First Hospital
- Study coordinator: Yi LIU
- Email: liuyipkuhsc@163.com
- Phone: +86 13611035261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.