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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Xiangya Hospital of Central South University
Study ID
NCT07690306
Status
Enrolling By Invitation

Conditions

  • Prostate Cancer (Diagnosis)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Jul 8, 2026
Start date
Jan 13, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: Prostate Cancer Group
  • Arm: Non-cancer (BPH) Control

Primary Outcome Measure

Area Under the Curve (AUC) of the AI Model for Detecting Clinically Significant Prostate Cancer [ Time Frame: At histopathological diagnosis by prostate biopsy or radical prostatectomy ]

Locations (1)

FacilityCityStateZIPSite coordinators
David Geffen School of Medicine University of California, Los Angeles(UCLA)Los AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By research site
David Geffen School of Medicine University of California, Los Angeles(UCLA)· Los Angeles, CA

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