NCT07631806Active, not recruiting
Intelligent Screening and Precision Diagnosis of Prostate Cancer Based on Multimodal Data
Prospective Validation of an AI-Assisted Multimodal Imaging-Pathology Fusion System for Precision Diagnosis and Biopsy Guidance in Patients With Suspected Prostate Cancer
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
This project aims to develop a precision screening and diagnostic solution for prostate cancer based on multimodal artificial intelligence, focusing on addressing the diagnostic challenge in patients within the PSA "gray zone" of 4-10 ng/mL. The project will integrate multidimensional information including ctDNA liquid biopsy, routine laboratory data, and prostate ultrasound images to develop three models: a ctDNA-based multimodal AI prediction model, a routine laboratory data-assisted decision model, and an ultrasound image AI-assisted diagnostic model. On this basis, a multimodal AI fusion decision system will be established to automatically generate individualized risk assessment reports and diagnostic recommendations. Additionally, a closed-loop mechanism of "clinical use - data feedback - model optimization" will be constructed to continuously iterate model parameters using pathological gold standards, thereby improving predictive accuracy in our hospital population. The project will form a generalizable precision diagnostic workflow, reduce unnecessary biopsies in "gray zone" patients, and provide an implementable in-hospital solution for precision medicine in prostate cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 2 Jun 2026
- Start date
- May 2026
- Primary completion date
- May 2028
- Lead sponsor
- Guangxi Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT07631806
What you commit to
- Study type: Observational
- Planned participants: 500
- From May 2026 to the primary completion date, May 2028
- 1 site 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
- Previously diagnosed with prostate cancer and receiving surgery, radiotherapy, or endocrine therapy
Other illness
- With other malignancies
Other
- Critical missing clinical data (e.g., missing PSA value, incomplete ultrasound report)
Who the study is looking for
- Age ≥45 years, male
- Presenting with abnormal serum PSA (≥4 ng/mL), abnormal digital rectal examination, or suspicious lesions on prostate ultrasound
- Undergoing prostate biopsy with definitive pathological results
- Signed informed consent
Age in the registry: 45 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangxi Medical University First Affiliated Hospital Coordinator of this site? Confirm its status | Nan'ning | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.