Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 602
- 试验地点
- 1
- 主要终点
- The detection rate of clinically significant prostate cancer by targeted biopsy alone
研究概览
简要总结
This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.
详细描述
This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •PSA > 4 ng/ml and/or abnormal DRE
- •Sign the informed consent
排除标准
- •Have acute or chronic prostatitis
- •Contraindications to prostate biopsy
- •Contraindications to MRI
- •Other reasons that not suitable for this trial
结局指标
主要结局
The detection rate of clinically significant prostate cancer by targeted biopsy alone
时间窗: 2-3 weeks post-biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
次要结局
- The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy(2-3 weeks post-biopsy)
- The detection rate of any prostate cancer by targeted biopsy alone(2-3 weeks post-biopsy)
- The detection rate of any prostate cancer by targeted biopsy combined with template biopsy(2-3 weeks post-biopsy)