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COMPLETED
NCT06575361
NA

Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

Official title: Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study

Key Details

Gender

MALE

Age Range

45 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

365

Start Date

2024-01-01

Completion Date

2025-08-31

Last Updated

2026-05-06

Healthy Volunteers

No

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China