AI prediction of lymph node spread in high‑risk prostate cancer
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
This study will test an AI model that uses MRI, pathology images, and routine clinical data to see if high‑risk prostate cancer patients have lymph node spread before prostate removal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07112599 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged ≥50 with biopsy‑confirmed prostate adenocarcinoma who meet high‑risk criteria (PSA ≥20 ng/ml or Gleason score ≥8), have ECOG 0–2, and can undergo pre‑operative MRI and radical prostatectomy with pelvic lymph node dissection.
Not a fit: Patients with low‑risk disease, those not having MRI or not proceeding to radical prostatectomy with lymph node dissection, or those with insufficient pathology or imaging data are unlikely to benefit.
Why it matters
Potential benefit: If successful, the model could help surgeons identify which patients truly have lymph node spread and personalize surgical or treatment planning, potentially avoiding unnecessary lymph node surgery.
How similar studies have performed: Previous research using imaging‑based or pathology‑based AI models has shown promising accuracy in predicting nodal status, but prospective multicenter validation like this is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hefei, Anhui
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.