NCT07690306Enrolling by invitation
Development and Validation of a Non-Invasive AI Diagnostic Model for Prostate Cancer Using Multiparametric MRI and PSMA PET/CT
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- 13 Jan 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Xiangya Hospital of Central South University
- Diseases
- Prostate cancer
- NCT number
- NCT07690306
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 13 Jan 2026 to the primary completion date, 30 Sept 2026
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate surgery (e.g., TURP)
- Prior endocrine therapy or radiotherapy
Other illness
- History of other malignant tumors
- Severe renal insufficiency
Other
- Major organ dysfunction or life expectancy \< 1 year
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| David Geffen School of Medicine University of California, Los Angeles(UCLA) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.