Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 626
- 试验地点
- 1
- 主要终点
- The detection rate of clinically significant prostate cancer for targeted biopsy
研究概览
简要总结
This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
详细描述
This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
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 increase to 4-20 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
研究组 & 干预措施
cognitive targeted biopsy
a cognitive fusion targeted biopsy combined with a systematic biopsy
干预措施: cognitive fusion targeted biopsy (Procedure)
software targeted biopsy
software-based fusion targeted biopsy combined with a systematic biopsy
干预措施: cognitive fusion targeted biopsy (Procedure)
结局指标
主要结局
The detection rate of clinically significant prostate cancer for targeted biopsy
时间窗: 5-6 weeks after signing the consent
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 any prostate cancer for targeted biopsy(5-6 weeks after signing the consent)
- The detection rate of clinically significant prostate cancer for combined biopsy(5-6 weeks after signing the consent)
- The detection rate of any prostate cancer for combined biopsy(5-6 weeks after signing the consent)
- Prostate volume(5-6 weeks after signing the consent)
- The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm(5-6 weeks after signing the consent)
- The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm(5-6 weeks after signing the consent)
- The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3(5-6 weeks after signing the consent)
- The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm(5-6 weeks after signing the consent)
- The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5(5-6 weeks after signing the consent)
- The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4(5-6 weeks after signing the consent)