AI prediction of lymph node spread in high‑risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective study will enroll men with high‑risk prostate cancer (PSA ≥20 ng/ml or Gleason score ≥8) who have pre‑biopsy MRI and are planning radical prostatectomy with pelvic lymph node dissection. Experienced radiologists and pathologists will manually outline tumor regions on MRI and scanned pathology sections, and those imaging features plus clinical data will be fed into an AI radiopathology model to generate a probability of lymph node metastasis. The model's predictions will be compared to histopathology from pelvic lymph node dissection to calculate sensitivity, specificity, positive and negative predictive values, and overall accuracy. The study aims to validate the model's diagnostic performance across participating centers to support more precise surgical planning.

Why it matters

Who can join: the full rules

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

Where it's running

• Science and Technology Institute, Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Sheng Tai
• Email: taisheng@ahmu.edu.cn
• Phone: +86 18355159268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.