Actively Recruiting

MALE
NCT06842264

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

Led by Peking University First Hospital · Updated on 2026-01-29

3000

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • The interval between prostate MRI and biopsy within 3 months
  • Integrity of related data
Not Eligible

You will not qualify if you...

  • PSA less than 50 ng/ml
  • Any treatment for prostate cancer prior to 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
  • Undergoing MRI with an indwelling urinary catheter or suprapubic catheter
  • Inadequate quality of MRI images

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, China, 100034

Actively Recruiting

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Research Team

Y

Yi LIU

CONTACT

Y

Yi LIU

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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