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AI-based Prediction of Prostate Cancer Metastasis Using Biopsy Pathology

Development and Validation of an AI-Based Metastasis Prediction Model Using Prostate Cancer Biopsy Pathology

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07660276
Enrollment
3000
Registered
2026-06-22
Start date
2026-01-08
Completion date
2026-08-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Metastatic

Brief summary

This observational study aims to develop and validate an artificial intelligence-based model using prostate cancer biopsy pathology to predict lymph node metastasis and distant metastasis in patients with prostate cancer. The main questions it aims to answer are: Can artificial intelligence-assisted analysis of prostate cancer biopsy pathology accurately predict lymph node metastasis? Can the model accurately predict distant metastasis and assess metastatic risk in patients with prostate cancer? Researchers aim to evaluate whether the model can provide additional information for clinical decision-making and surgical planning. Participants will: Provide prostate biopsy pathology specimens and related clinical information; Undergo assessment of lymph node and distant metastatic status based on clinical and imaging data; Be included in the development and validation of the artificial intelligence prediction model.

Interventions

OTHERArtificial Intelligence-Based Pathology Analysis

Artificial intelligence-assisted analysis of prostate cancer biopsy pathology specimens for prediction of lymph node and distant metastasis risk.

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

\- Male patients aged between 18 and 90 years; Patients who underwent prostate biopsy due to elevated prostate-specific antigen (PSA), abnormal digital rectal examination (DRE), or abnormal imaging findings, were pathologically diagnosed with prostate cancer, and had available prostate biopsy pathology specimens; Patients who underwent radical prostatectomy with extended pelvic lymph node dissection (ePLND) or pelvic lymph node dissection (PLND), with definitive pathological information regarding lymph node metastasis; Patients who underwent PSMA PET/CT, MRI, bone scintigraphy, or prostate MRI capable of identifying regional lymph node metastasis or distant metastasis; Adequate cardiac, pulmonary, hepatic, and renal function; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Expected survival time greater than 1 year; Written informed consent signed by the patient or legally authorized representative.

Exclusion criteria

\- History of other malignancies; Severe dysfunction of major organs, including cardiac, pulmonary, hepatic, or renal insufficiency, or an expected survival time of less than 1 year; Prostate biopsy pathology specimens with inadequate whole-slide image scanning quality or failure of quality control assessment; Patients with prostate cancer diagnosed from transurethral resection specimens.

Design outcomes

Primary

MeasureTime frameDescription
Prediction of Regional Lymph Node MetastasisBaselineAssessment of the ability of the artificial intelligence-based model using prostate cancer biopsy pathology to predict regional lymph node metastasis.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORYi Cai

Xiangya Hospital Central South University Department of Urology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026