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临床试验/NCT06589154
NCT06589154已完成不适用

The Application of Multimodal Artificial Intelligence Systems in Prostate Cancer Diagnosis and Prognosis Analysis

Shanghai Changzheng Hospital16 个研究点 分布在 1 个国家目标入组 1,651 人开始时间: 2024年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,651
试验地点
16
主要终点
Sensitivity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

研究概览

简要总结

Prostate-specific antigen (PSA) testing has limited specificity for prostate cancer diagnosis, leading to a high rate of unnecessary biopsies. This multi-center study aims to develop and validate a non-invasive, multi-modal artificial intelligence model that combines cell-free DNA (cfDNA) profiles with multi-parametric MRI (mpMRI). The primary goal is to improve the accuracy of prostate cancer detection and risk stratification, particularly for men with PSA levels in the 4-10 ng/mL "gray zone," thereby providing a robust tool to guide clinical decision-making and reduce avoidable invasive procedures.

详细描述

Prostate cancer is a leading cause of cancer morbidity in men globally. The current diagnostic pathway, heavily reliant on PSA levels, is particularly challenging in the 4-10 ng/mL "gray zone," where its inability to reliably distinguish benign conditions from cancer results in a substantial number of unnecessary biopsies and the overtreatment of indolent disease.

While advanced non-invasive methods like cfDNA analysis and mpMRI have shown individual promise, each possesses inherent limitations when used as a standalone tool. cfDNA assays can lack sensitivity due to low tumor fraction, and mpMRI interpretation is subject to variability and has suboptimal accuracy. This study hypothesizes that a synergistic fusion of these complementary data modalities-integrating the systemic molecular information from cfDNA with the localized anatomical and functional data from mpMRI-can overcome these limitations.

To test this hypothesis, we developed a multimodal Model, an end-to-end deep learning framework. This study was designed to rigorously develop and validate the BEAM model across a large, multi-center population, including a retrospective discovery cohort and two prospective validation cohorts. The ultimate goal is to establish a powerful, non-invasive tool that can accurately detect prostate cancer and, critically, stratify patients by risk of clinically significant disease, thereby personalizing patient management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men aged 18-80 years with a clinical indication for prostate or pelvic magnetic resonance (MR) examination.
  • Patients with normal prostate, benign prostatic hyperplasia, or prostate cancer.
  • First visit on January 1, 2014, or later.

排除标准

  • Diagnosis of any other malignancy within the previous 5 years.
  • Prior transurethral resection or enucleation of the prostate before imaging.
  • Any condition deemed by the investigator to make the patient unsuitable for study participation.

结局指标

主要结局

Sensitivity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

时间窗: Through completion of study and all data analysis which may take up to one year.

Specificity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

时间窗: Through completion of study and all data analysis which may take up to one year.

ROC value of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

时间窗: Through completion of study and all data analysis which may take up to one year.

次要结局

  • ROC value of a Prostate Cancer Multimodal Model in Predicting the Pathological Outcomes of Gleason Score Categories (≤6, 7, ≥8) in Men Underwent for Prostate Biopsy(Through completion of study and all data analysis which may take up to one year.)
  • Sensitivity of a Prostate Cancer Multimodal Model in Predicting the Pathological Outcomes of Gleason Score Categories (≤6, 7, ≥8) in Men Underwent for Prostate Biopsy(Through completion of study and all data analysis which may take up to one year.)
  • Specificity of a Prostate Cancer Multimodal Model in Predicting the Pathological Outcomes of Gleason Score Categories (≤6, 7, ≥8) in Men Underwent for Prostate Biopsy(Through completion of study and all data analysis which may take up to one year.)
  • ROC value of a Prostate Cancer Multimodal Model in Predicting Clinically Significant Prostate Cancer (csPCa) in Men Underwent Prostate Biopsy(Through completion of study and all data analysis which may take up to one year.)
  • Sensitivity of a Prostate Cancer Multimodal Model in Predicting Clinically Significant Prostate Cancer (csPCa) in Men Underwent Prostate Biopsy(Through completion of study and all data analysis which may take up to one year.)
  • Specificity of a Prostate Cancer Multimodal Model in Predicting Clinically Significant Prostate Cancer (csPCa) in Men Underwent Prostate Biopsy(Through completion of study and all data analysis which may take up to one year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ren Shancheng

Professor, Chief of Urology

Shanghai Changzheng Hospital

研究点 (16)

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