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

NCT07112599 | Recruiting

• 1 other identifier: PJ 2025-04-44
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Lymph Node Cancer Metastatic; Artificial Intelligence (AI)

Keywords

prostate cancer; AI

Outcome Measures

Primary Outcomes (1)

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

  The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics and pathomics artificial intelligence model for predicting lymph node metastasis in high-risk prostate cancer patients

  baseline

Secondary Outcomes (1)

• The specificity of the radiopathology artificial intelligence model

  baseline

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high-risk prostate cancer (PSA ≥ 20ng/ml or Gleason ≥ 8)

You may qualify if:

• Age ≥ 50 years
• Patients must have histologically or cytologically confirmed prostate adenocarcinoma
• PSA ≥ 20ng/ml or Gleason ≥ 8
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2
• Life expectancy ≥ 6 months
• 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
• 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
• Total bilirubin ≤ 1.5 times ULN or total bilirubin \> 1.5 times ULN and direct bilirubin ≤ ULN;
• Normal coagulation function: International Normalized Ratio（INR） ≤ 1.5, partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) \< ULN + 4 seconds
• Normal heart function: left ventricular ejection fraction (LVEF) ≥ 50%; corrected QT interval male \< 450ms, female \< 470ms, serum potassium ≥ 3.5mmol/L
• Normal blood pressure: systolic blood pressure \< 140mmHg, diastolic blood pressure \< 90mmHg; patients with stable blood pressure assessment after appropriate clinical treatment can be enrolled
• Normal renal function: serum creatinine ≤ 1.5 times ULN, and creatinine clearance ≥ 50 mL/min
• Prospective subjects can understand and are willing to sign the informed consent form
• Able to comply with the study visit schedule and other protocol requirements

You may not qualify if:

• Patients with contraindications to MRI examination, such as metal implants in the body, claustrophobia, etc.
• Patients with any missing baseline clinical and pathological information
• Patients with a clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or seizures
• 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
• The investigator believes that it is not suitable to participate in this clinical trial for any reason
• Unable to provide informed consent

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Science and Technology Institute, Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Sheng Tai

CONTACT

+86 18355159268; taisheng@ahmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: January 25, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)