A Phase 3, Multicenter, International, Non-inferiority, Randomized Clinical Trial Comparing Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging (MUSIC-Screen)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,284
- 试验地点
- 10
- 主要终点
- Detection of Clinically significant prostate cancer.
研究概览
简要总结
The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the prostate gland. Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS. The study is looking to identify the most effective imaging modality to help guide whether you progress to have a 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
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •PSA 3-20 and/or abnormal DRE;
- •Biopsy naïve.
排除标准
- •Prior personal history of prostate cancer;
- •Prior prostate imaging using microUS or MRI;
- •Contraindication to microUS or MRI;
- •Testosterone replacement therapy within last 12 months; or
- •Androgen deprivation therapy within last 12 months.
研究组 & 干预措施
microUltransound
干预措施: ExactVu (Device)
MRI
干预措施: MRI (Device)
结局指标
主要结局
Detection of Clinically significant prostate cancer.
时间窗: Once enrolled, men will be followed for 1 year after the imaging test.
The primary objective of this trial is to determine if a screening pathway using microUS is non-inferior to a pathway using MRI for the detection of clinically significant prostate cancer, defined as Gleason Grade Group 2 or more.
次要结局
未报告次要终点