Comparing AI-guided prostate biopsies to routine biopsies for cancer diagnosis
Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Multicenter Randomized Controlled Clinical Trial
This study is testing if using artificial intelligence to guide prostate biopsies can find cancer more accurately than the usual biopsy method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | Male |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06392737 on ClinicalTrials.gov |
What this trial studies
This multicenter clinical trial aims to compare the cancer detection rates of MRI artificial intelligence-guided cognitive targeted biopsy (AI-cTB) with routine cognitive targeted biopsy (cTB) in diagnosing prostate cancer. The study will assess whether AI can enhance the accuracy of prostate cancer diagnosis and treatment, and evaluate the effectiveness of the AI-assisted system in predicting pathological results. Participants will receive either AI-cTB or routine cTB based on their eligibility, which includes specific imaging and clinical criteria. The trial seeks to validate the generalizability of the AI system across different institutions.
Who should consider this trial
Good fit: Ideal candidates are men aged 45 to 85 with suspicious prostate lesions and appropriate imaging results.
Not a fit: Patients without suspicious lesions or those not meeting the biopsy criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and effective diagnosis of prostate cancer, improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using AI for prostate cancer diagnosis, but this multicenter approach aims to further validate its effectiveness.
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, 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 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. * The patients could not cooperate to complete the systematic biopsy combined with targeted biopsy. The patients or their family members refused to participate in this study. * Patients with incomplete clinical information.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, 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.