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Clinical trial Recruiting at 1 site Interventional Ages 45 to 85 Men only

Comparing AI-guided prostate biopsies to routine biopsies for cancer diagnosis

Official title: 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

Run by Peking University First Hospital · NCT06392737 · Data updated 2026-11-12

This study is testing if using artificial intelligence to guide prostate biopsies can find cancer more accurately than the usual biopsy method.

More Prostate Cancer trials

Quick facts

Study typeInterventional
Ages45 Years to 85 Years
SexMen only
Enrollment360 (estimated)
SponsorPeking University First Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMay 1, 2024
Main results expectedMarch 31, 2026
Study endsApril 30, 2026
Registry record updatedJuly 2, 2025
Trial IDNCT06392737 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 45 to 85 with suspicious prostate lesions and appropriate imaging results.

Probably not a fit

Patients without suspicious lesions or those not meeting the biopsy criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown promise in using AI for prostate cancer diagnosis, but this multicenter approach aims to further validate its effectiveness.

Who can join: the full rules

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 it's running

  • Peking University First Hospital
    Beijing, Beijing Municipality, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464Peking University First Hospital 99
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.