NCT07112599 Study of Predicting Lymph Node Metastasis of High-risk Prostate Cancer by Artificial Intelligence Multi-omics Analysis

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 2,000 participants in total. It began in 2026-01-25 with a primary completion date of 2026-12-30.

Brief Summary

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.

Eligibility Criteria

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

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