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ENROLLING BY INVITATION
NCT07690306

Development and Validation of a Non-Invasive AI Diagnostic Model for Prostate Cancer Using Multiparametric MRI and PSMA PET/CT

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

Prostate cancer is one of the most common malignancies in men. Currently, due to the limited diagnostic accuracy of existing imaging tests, there is a risk of missed diagnosis or unnecessary prostate biopsy. This study aims to develop and validate a non-invasive artificial intelligence (AI) diagnostic model using two advanced imaging techniques: multiparametric MRI (mpMRI) and PSMA PET/CT. By integrating information from both imaging modalities, the AI model is expected to improve the diagnostic accuracy of prostate cancer, reduce unnecessary biopsies, and assist physicians in making better clinical decisions. This is a retrospective, multicenter study that plans to collect imaging and pathology data from approximately 1,000 to 1,500 patients across six major hospitals in China. The diagnostic performance of the model will be evaluated, including its ability to identify clinically significant prostate cancer and its value in assisting diagnosis in patients with PSA levels in the gray zone (4-20 ng/mL).

Official title: A Retrospective, Multicenter Study to Develop and Validate a Non-Invasive Artificial Intelligence Diagnostic Model for Prostate Cancer Using Multiparametric MRI and PSMA PET/CT, With Pathologically Confirmed Diagnosis as the Reference Standard

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2026-01-13

Completion Date

2026-12-31

Last Updated

2026-07-08

Healthy Volunteers

No

Locations (5)

Beijing Hospital

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China