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Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis

NCT06575361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2026-05-06

No results posted yet for this study

Summary

The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are:

Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists.

Participants will:

Receive combination of systematic biopsy and targeted biopsy.

Conditions

Interventions

DIAGNOSTIC_TEST

Combination of targeted biopsy and systematic biopsy

Before prostate biopsy, the MR images of patients were independently reviewed by MRI-AI and urogenital radiologists. Then the images with suspicious lesions highlighted by MRI-AI and urogenital radiologists. Urologists conducted targeted biopsies for all suspicious lesions and systematic biopsies. Biopsies were performed under the guidance of transrectal ultrasound (TRUS) through the transrectal or transperineal route.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Yi LIU · Peking University First Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-06-30
Completion
2025-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575361 on ClinicalTrials.gov