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Clinical trial Recruiting at 1 site Observational Men only

Developing AI models to predict clinically significant prostate cancer using MRI

Official title: The Development and Validation of MRI-AI-based Predictive Models for csPCa

Run by Peking University First Hospital · NCT06842264 · Data updated 2026-11-12

This study is testing if using artificial intelligence with MRI scans can help predict significant prostate cancer in men who are undergoing testing for the disease.

Quick facts

Study typeObservational
SexMen only
Enrollment3000 (estimated)
SponsorPeking University First Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedJanuary 29, 2026
Trial IDNCT06842264 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men who have undergone prostate MRI and are scheduled for a biopsy within three months.

Probably not a fit

Patients with a PSA level below 50 ng/ml or those who have received prior treatment for prostate cancer 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 observational study aims to develop and validate predictive models for clinically significant prostate cancer (csPCa) using artificial intelligence and magnetic resonance imaging (MRI). It includes a retrospective analysis of patients who underwent MRI and subsequent biopsy at Peking University First Hospital from January 2019 to December 2023, followed by prospective enrollment from January 2024 to December 2029. Clinical data such as age, PSA levels, and imaging scores are collected, and an AI model is utilized to analyze prostate volumes and calculate specific antigen densities. The goal is to create machine learning models that can accurately predict csPCa based on the collected data.

Why it matters

Potential benefit: If successful, this study could lead to more accurate predictions of clinically significant prostate cancer, improving early detection and treatment strategies for patients.

How similar studies have gone: While the use of AI in medical imaging is a growing field, this specific approach to predicting csPCa using MRI data is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* The interval between prostate MRI and biopsy within 3 months
* Integrity of related data

Exclusion Criteria:

* PSA less than 50ng/ml
* Any treatment for PCa prior to either MRI or biopsy, including radical prostatectomy, radiotherapy, chemotherapy, and endocrine therapy
* Previous history of surgical treatment or 5α-reductase inhibitor therapy for benign prostatic hyperplasia
* Subjects undergoing MRI with an indwelling urinary catheter or suprapubic catheter
* Inadequate quality of MRI images

Where it's running

  • Peking University First Hospital
    Beijing, 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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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.