ActiveNCT07631806

Prospective Validation of an AI-Assisted Multimodal Imaging-Pathology Fusion System for Precision Diagnosis and Biopsy Guidance in Patients With Suspected Prostate Cancer

Sponsor: Guangxi Medical University

Trial Details

Condition	Prostate Cancer With PSA Gray Zone
Status	Active
Participants	500
Est. Completion	1 June 2028
Last Updated	17 June 2026

Primary Outcome

Area Under the Curve (AUC) of the multimodal AI fusion diagnostic system

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Age ≥45 years, male 2. Presenting with abnormal serum PSA (≥4 ng/mL), abnormal digital rectal examination, or suspicious lesions on prostate ultrasound 3. Undergoing prostate biopsy with definitive pathological results 4. Signed informed consent Exclusion Criteria: 1. Previously diagnosed with prostate cancer and receiving surgery, radiotherapy, or endocrine therapy 2. With other malignancies 3. Critical missing clinical data (e.g., missing PSA value, incomplete ultrasound report)

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Related Analysis

Phase IV Validation Trial Opens: AI-Assisted Multimodal Imaging System for Prostate Cancer Diagnosis in PSA Gray Zone — What Clinicians Need to Know

New validation study examines AI-assisted multimodal diagnostic system for prostate cancer in the challenging PSA gray zone of 4-10 ng/mL. The system integrates liquid biopsy, imaging, and laboratory data to potentially reduce unnecessary biopsies while maintaining diagnostic accuracy.

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