Clinical trial · Observational
Study of Predicting Lymph Node Metastasis of High-risk Prostate Cancer by Artificial Intelligence Multi-omics Analysis
Clinical Study on Predicting Lymph Node Metastasis of High-risk Prostate Cancer Based on Artificial Intelligence Multi-omics Analysis:A Multicenter, Prospective and Observational Clinical Study
- 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)
The pathological-omics and imaging-omics in this study are combined to construct an artificial intelligence (AI) model that can predict whether high-risk prostate cancer patients may have lymph node metastasis. The model determines whether the patient has lymph node metastasis based on the MRI results and the pathological section image information of the case combined with clinical data before radical resection of the prostate. This study is a multicenter, prospective clinical study to verify the model's ability to predict whether high-risk prostate cancer patients may have lymph node metastasis.
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 |
|---|---|---|---|
| Artificial Intelligence (AI) | — | UNRESOLVED | — |
| Lymph Node Cancer Metastatic | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiopathology artificial intelligence model
- timeFrame
- baseline
- description
- The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics and pathomics artificial intelligence model for predicting lymph node metastasis in high-risk prostate cancer patients
Secondary outcomes (1)
- measure
- The specificity of the radiopathology artificial intelligence model
- timeFrame
- baseline
- description
- The specificity of the radiomics and pathomics artificial intelligence model for predicting lymph node metastasis in high-risk prostate cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 50 years 2. Patients must have histologically or cytologically confirmed prostate adenocarcinoma 3. PSA ≥ 20ng/ml or Gleason ≥ 8 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2 5. Life expectancy ≥ 6 months 6. Normal bone marrow function: absolute neutrophil count ≥ 1.5×109/L; platelets ≥ 75×109/L; hemoglobin ≥ 90g/L; white blood cell count ≥ 3.0×109/L 7. Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); for patients with liver metastasis, ALT/AST can be ≤ 5 times ULN 8. Total bilirubin ≤ 1.5 times ULN or total bilirubin \> 1.5 times ULN and direct bilirubin ≤ ULN; 9. Normal coagulation function: International Normalized Ratio(INR) ≤ 1.5, partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) \< ULN + 4 seconds 10. Normal heart function: left ventricular ejection fraction (LVEF) ≥ 50%; corrected QT interval male \< 450ms, female \< 470ms, serum potassium ≥ 3.5mmol/L 11. Normal blood pressure: systolic blood pressure \< 140mmHg, diastolic blood pressure \< 90mmHg; patients with stable blood pressure assessment after appropriate clinical treatment can be enrolled 12. Normal renal function: serum creatinine ≤ 1.5 times ULN, and creatinine clearance ≥ 50 mL/min 13. Prospective subjects can understand and are willing to sign the informed consent form 14. Able to comply with the study visit schedule and other protocol requirements Exclusion Criteria: 1. Patients with contraindications to MRI examination, such as metal implants in the body, claustrophobia, etc. 2. Patients with any missing baseline clinical and pathological information 3. Patients with a clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or seizures 4. In the judgment of the investigator, there are serious concomitant diseases that endanger the safety of the subjects or affect the subjects' completion of this study (such as severe diabetes, thyroid disease, and mental illness, etc.), or factors that affect the safety of the patients or affect the patients' provision of informed consent (including laboratory abnormalities), or any psychological, family, sociological or geographical conditions that affect the study plan and follow-up plan 5. The investigator believes that it is not suitable to participate in this clinical trial for any reason 6. Unable to provide informed consent
References
Publications (0)
Data not yet available