Clinical trial · Observational
The Development and Validation of MRI-AI-based Predictive Models for csPCa
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- cohort 1
- description
- Cohort 1 comprises patients who underwent prostate magnetic resonance imaging (MRI) at Peking University First Hospital between January 2024 and December 2029, followed by an ultrasound-guided prostate biopsy.
Primary outcomes (1)
- measure
- Biopsy pathology results
- timeFrame
- 1week after biopsy
- description
- The pathology report will include the ISUP grade; if it is greater than or equal to 2, it is considered csPCa (clinically significant prostate cancer), otherwise, it is classified as non-csPCa.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available