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

Enrolling by invitation

Conditions studied: Prostate Cancer (Diagnosis)

In brief

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).

Key facts

Study ID

NCT07690306

Run by

Xiangya Hospital of Central South University

People needed

1500

Starts

2026-01-13

Expected to finish

2026-12-31

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• ECOG performance status 0-2.
• Life expectancy > 6 months.
• Underwent mpMRI and PSMA PET/CT before systemic treatment or radical prostatectomy, with original DICOM data available for export.
• Has pathological diagnosis from prostate biopsy or radical prostatectomy as the gold standard.
• Complete clinical data available, including pre-treatment PSA (tPSA, fPSA), TNM stage, Gleason score, PI-RADS score, SUVmax, prostate volume (from MRI/PSMA PET), age, and BMI.
• Informed consent for data use for research purposes according to each center's ethics requirements.

You may not qualify if…

• History of other malignant tumors
• Previous prostate surgery (e.g., TURP)
• Prior endocrine therapy or radiotherapy
• Severe renal insufficiency
• Major organ dysfunction or life expectancy < 1 year

Where it is running

• 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

Full record on ClinicalTrials.gov

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