Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Identification of prostate cancer foci
研究概览
简要总结
This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.
详细描述
PRIMARY OBJECTIVE:
I. Determine if micro-ultrasound (US) can be used to identify prostate cancer foci with equivalent (non-inferior) performance relative to multiparametric magnetic resonance imaging (mpMRI).
SECONDARY OBJECTIVE:
I. Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI.
TERTIARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Standard-of-care mpMRI within the past 12 months
- •Biopsy-proven prostate cancer, Gleason grade >= 3+3
- •Maximum posterior-to-anterior prostate dimension of =< 6 cm
- •Scheduled to receive standard-of-care radical prostatectomy
排除标准
- •Maximum posterior-to-anterior prostate dimension greater than 6 cm
- •Prior radiation or focal treatment for prostate cancer
- •Inability to have a transrectal ultrasound scan
- •Prostate biopsy < 4 weeks prior to surgery
结局指标
主要结局
Identification of prostate cancer foci
时间窗: Up to 3 years
Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci. Measurement tool = chi squared test
次要结局
- Contours of prostate cancer foci(Up to 3 years)