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

Launched by ANHUI MEDICAL UNIVERSITY · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict whether men with high-risk prostate cancer have cancer that has spread to their lymph nodes. Researchers are using advanced technology called artificial intelligence (AI) to analyze medical images and tissue samples, combined with health information, to create a model that can help doctors know if the cancer has spread before surgery. This study will take place at multiple centers and aims to test how well this AI model works in real patients.

Men aged 50 and older with confirmed prostate cancer who have certain signs of more aggressive disease—such as a high PSA level (a blood test related to prostate cancer) or a high Gleason score (a measure of how aggressive the cancer looks under a microscope)—may be eligible to join. Participants should be generally healthy enough to safely undergo MRI scans and surgery and able to follow study visits. If you join, you can expect to have MRI scans and provide clinical information before your prostate surgery, which will help the AI model make its prediction. This study is not yet recruiting, but it offers a promising way to improve how doctors understand prostate cancer spread, potentially leading to better treatment decisions.

Gender

MALE

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