Actively Recruiting

Age: 50Years +
MALE
NCT07112599

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

Led by Anhui Medical University · Updated on 2026-01-09

2000

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • PSA 20 ng/ml or higher or Gleason score 8 or higher
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Life expectancy of at least 6 months
  • Normal bone marrow function: absolute neutrophil count ≥ 1.5×10⁹/L; platelets ≥ 75×10⁹/L; hemoglobin ≥ 90 g/L; white blood cell count ≥ 3.0×10⁹/L
  • Normal liver function: ALT or AST ≤ 2.5 times upper limit of normal (ULN); if liver metastasis present, ALT/AST ≤ 5 times ULN
  • Total bilirubin ≤ 1.5 times ULN or total bilirubin > 1.5 times ULN with direct bilirubin ≤ ULN
  • Normal coagulation function: INR ≤ 1.5, APTT ≤ 1.5 times ULN, PT < ULN + 4 seconds
  • Normal heart function: LVEF ≥ 50%; corrected QT interval male < 450 ms, female < 470 ms; serum potassium ≥ 3.5 mmol/L
  • Normal blood pressure: systolic < 140 mmHg, diastolic < 90 mmHg; stable blood pressure after treatment allowed
  • Normal renal function: serum creatinine ≤ 1.5 times ULN, creatinine clearance ≥ 50 mL/min
  • Ability to understand and willing to sign informed consent
  • Able to comply with study visits and protocol requirements
Not Eligible

You will not qualify if you...

  • Contraindications to MRI such as metal implants or claustrophobia
  • Missing baseline clinical or pathological information
  • History of neurological or psychiatric disorders including dementia, epilepsy, or seizures
  • Serious diseases endangering safety or affecting study completion (e.g., severe diabetes, thyroid disease, mental illness)
  • Factors affecting safety or ability to provide informed consent including lab abnormalities or psychological, family, social, or geographic issues
  • Investigator judgment deeming participation unsuitable
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Science and Technology Institute, Anhui Medical University

Hefei, Anhui, China, 230022

Actively Recruiting

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Research Team

S

Sheng Tai

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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