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COMPLETED
NCT06589154

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

Sponsor: Shanghai Changzheng Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

1651

Start Date

2024-10-10

Completion Date

2025-07-30

Last Updated

2026-07-23

Healthy Volunteers

Yes

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.

Locations (10)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Jiangsu Provincial People's Hospita

Nanjing, Jiangsu, China

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Northern Jiangsu People's Hospita

Yangzhou, Jiangsu, China

Changhai Hospital

Shanghai, Shanghai Municipality, China

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Ningbo No. 1 Hospita

Ningbo, Zhejiang, China