Development and Validation of an AI-Based Metastasis Prediction Model Using Prostate Cancer Biopsy Pathology
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •- 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.
研究组 & 干预措施
Prostate Cancer Cohort
Patients with prostate cancer undergoing biopsy pathology assessment for development and validation of an AI-based metastasis prediction model.
干预措施: Artificial Intelligence-Based Pathology Analysis (Other)