NCT06842264Recruiting
The Development and Validation of MRI-AI-based Predictive Models for csPCa
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 11 Feb 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Peking University First Hospital
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT06842264
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 Jan 2024 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- PSA less than 50ng/ml
- Subjects undergoing MRI with an indwelling urinary catheter or suprapubic catheter
- Inadequate quality of MRI images
Who the study is looking for
- The interval between prostate MRI and biopsy within 3 months
- Integrity of related data
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.