The Development and Validation of MRI-AI-based Predictive Models for csPCa
Recruiting · NCT06842264 · Observational (researchers observe without assigning treatment) · Lead sponsor: Peking University First Hospital
View the official record on ClinicalTrials.gov →What this trial is about
This study retrospectively included patients who underwent prostate magnetic resonance imaging (MRI) and subsequent ultrasound-guided prostate biopsy at Peking University First Hospital from January 2019 to December 2023, and prospectively enrolls patients from January 2024 to December 2029. Clinical information such as age, PSA levels, PI-RADS scores, and digital rectal examination findings are collected. A well-performing artificial intelligence model is employed to measure prostate volume, transitional zone volume, and lesion volume using MRI images. Furthermore, prostate-specific antigen density (PSAD), transitional zone-based prostate-specific antigen density (TZ-PSAD) and lesion-based prostate-specific antigen density (lesion-PSAD) are calculated using prostate volume, transitional zone volume and lesion volume. Utilizing the aforementioned data, machine learning predictive models for clinically-significant prostate cancer (csPCa) are developed and validated.
Who can take part
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 is running
1 location listed.
- Peking University First Hospital - Beijing, China