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The Application of Multimodal Artificial Intelligence Systems in Prostate Cancer Diagnosis and Prognosis Analysis

NCT06589154 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1651

Last updated 2025-09-02

No results posted yet for this study

Summary

Prostate-specific antigen (PSA) testing has limited specificity for prostate cancer diagnosis, leading to a high rate of unnecessary biopsies. This multi-center study aims to develop and validate a non-invasive, multi-modal artificial intelligence model that combines cell-free DNA (cfDNA) profiles with multi-parametric MRI (mpMRI). The primary goal is to improve the accuracy of prostate cancer detection and risk stratification, particularly for men with PSA levels in the 4-10 ng/mL "gray zone," thereby providing a robust tool to guide clinical decision-making and reduce avoidable invasive procedures.

Conditions

Interventions

DIAGNOSTIC_TEST

Multi-modal artificial intelligence model (BEAM)

Data from mpMRI and cfDNA analysis will be integrated and processed by deep learning. The model's output will be compared against the final pathological diagnosis from the prostate biopsy to evaluate its performance.

Sponsors & Collaborators

  • Ningbo No. 1 Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Jiangsu Provincial People's Hospital

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Zhongda Hospital

    collaborator OTHER

  • Northern Jiangsu People's Hospital

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Shanghai Changzheng Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2025-07-30
Completion
2025-07-30

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 NCT06589154 on ClinicalTrials.gov