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
Trial ID: NCT07112599
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-01-25
Completion date: 2027-06-30
Sponsor: Anhui Medical University
Conditions: Prostate Cancer; Lymph Node Cancer Metastatic; Artificial Intelligence (AI)
Locations: Science and Technology Institute, Anhui Medical University
Countries: China
Enrollment: 2000
Age range: 50 Years - None
Sex: MALE

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

Outcomes:
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiopathology artificial intelligence model