A Pilot Evaluation of the Efficacy of HistoScanning™ in Predicting the Presence and Location of Prostate Cancer in Men Undergoing Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Correlation of Histoscan findings with Radical Prostatectomy Pathology
研究概览
简要总结
This pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients undergoing surgery. Diagnostic procedures, such as ultrasound imaging, may help find and diagnose prostate cancer. This study will serve as an analysis of the Histo-Scanning technology for the purpose of determining its ability to identify sites of prostate cancer at the time of prostate ultrasound.
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
- •Patients who have completed a staging multiparametric MRI at New York University (NYU)
- •Patients who plan to undergo radical prostatectomy by open or robotic approach
排除标准
- •Previous History of Prostate Cancer Radiation Treatment
- •Focal Ablation of the prostate for cancer treatment
- •Men receiving hormonal ablation within 6 months prior to undergoing radical prostatectomy
研究组 & 干预措施
Ultrasound Imaging
Men already electing to undergo radical prostatectomy will undergo transrectal ultrasound procedure at induction of anesthesia prior to their surgery procedure.
干预措施: Ultrasound Imaging (Procedure)
结局指标
主要结局
Correlation of Histoscan findings with Radical Prostatectomy Pathology
时间窗: up to 3 years
Compare location and concordance of findings on pre-op MRI \& Histoscan with radical prostatectomy specimen
次要结局
- Extent of tumor and grade in treatment planning(Up to 3 years)