Clinical trial · Observational
The Application of Multimodal Artificial Intelligence Systems in Prostate Cancer Diagnosis and Prognosis Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Healthy People | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-modal artificial intelligence model (BEAM) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Discovery cohort
- description
- Participants with PSA levels \>4 ng/mL and had undergone prostatic biopsy and mpMR according to the investigators retrospectively.
- interventionNames
- Diagnostic Test: Multi-modal artificial intelligence model (BEAM)
- label
- Prospective internal validation cohort
- description
- Patients who are scheduled for prostate biopsy and mpMR, with PSA levels in the 4-10 ng/mL gray zone, will be consented and enrolled in this group prospectively.
- interventionNames
- Diagnostic Test: Multi-modal artificial intelligence model (BEAM)
- label
- Prospective external validation cohort
- description
- Patients who are scheduled for prostate biopsy and mpMR, with PSA levels in the 4-10 ng/mL gray zone, will be consented and enrolled in this group prospectively.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of any other malignancy within the previous 5 years. * Prior transurethral resection or enucleation of the prostate before imaging. * Any condition deemed by the investigator to make the patient unsuitable for study participation.
References
Publications (0)
Data not yet available