Developing AI models to predict clinically significant prostate cancer using MRI
The Development and Validation of MRI-AI-based Predictive Models for csPCa
Peking University First Hospital · NCT06842264
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 type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | Male |
| Sponsor | Peking University First Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06842264 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men who have undergone prostate MRI and are scheduled for a biopsy within three months.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing
- Peking University First Hospital — Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Yi LIU — Dept. of Urology, Peking University First Hospital
- Study coordinator: Yi LIU
- Email: liuyipkuhsc@163.com
- Phone: +8613611035261
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.
Conditions: Prostate Cancer, clinically-significant prostate cancer, artificial intelligence, magnetic resonance imaging, predictive model