NCT06589154Completed
The Application of Multimodal Artificial Intelligence Systems in Prostate Cancer Diagnosis and Prognosis Analysis
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1651 (actual)
- First submitted
- 6 Sept 2024
- Start date
- 10 Oct 2024
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Shanghai Changzheng Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06589154
What you commit to
- Study type: Observational
- Participants enrolled: 1651
- From 10 Oct 2024 to the primary completion date, 30 Jul 2025
- 10 sites in 1 country
- 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
- Diagnosis of any other malignancy within the previous 5 years.
- Prior transurethral resection or enucleation of the prostate before imaging.
Other illness
- Any condition deemed by the investigator to make the patient unsuitable for study participation.
Who the study is looking for
- Men aged 18-80 years with a clinical indication for prostate or pelvic magnetic resonance (MR) examination.
- Patients with normal prostate, benign prostatic hyperplasia, or prostate cancer.
- First visit on January 1, 2014, or later.
Age in the registry: 18 years to 80 years · Sex: Male · Accepts healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Jiangsu Provincial People's Hospita Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Ningbo No. 1 Hospita Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Northern Jiangsu People's Hospita Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.