Transrectal Ultrasound Robot-Assisted Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 483
- 试验地点
- 1
- 主要终点
- Investigational device serious adverse events
研究概览
简要总结
Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).
详细描述
This study attempts to improve TRUS-guided prostate biopsy by utilizing assistance from a novel robotic TRUS manipulator (TRUS-Robot) developed by our team. The hypothesis of the study is that clinically significant prostate cancer detection rate from the SB cores (at SB or TB+SB) can be improved above that of current devices. The objective of the study is to gain early evidence on the effectiveness of prostate biopsy assisted by the TRUS-Robot vs. a current TB device in a randomized clinical trial.
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
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Scheduled for an initial diagnostic biopsy
- •Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam
排除标准
- •Clinical diagnosis of prostate cancer
- •Prior prostate biopsy
- •Anal stenosis that prevents TRUS probe insertion
- •Inadequate bowel prep
- •Unwilling or unable to sign the informed consent
研究组 & 干预措施
TRUS-Robot and TRUS
TRUS and TRUS-Robot will be used during prostate biopsy
干预措施: TRUS-Robot (Device)
TRUS-Robot and TRUS
TRUS and TRUS-Robot will be used during prostate biopsy
干预措施: TRUS biopsy (Other)
Routine TRUS/Fusion biopsy
Just Uronav will be used during prostate biopsy
干预措施: TRUS biopsy (Other)
结局指标
主要结局
Investigational device serious adverse events
时间窗: 5 years
Serious adverse events will be assessed according to 21 Code of Federal Regulations (CFR) Part 812.3(s).
Cancer Detection Rate of Clinically Significant Prostate Cancer
时间窗: 5 years
Number of biopsy patients diagnosed with Gleason score \>= 7 over the total number of patients on both arms of the study.
Cancer Detection Rate of Clinically Insignificant Prostate Cancer
时间窗: 5 years
Number of biopsy patients diagnosed with Gleason score \<= 6 over the total number of patients on both arms of the study.
次要结局
- Predictive rates of detecting clinically significant prostate cancer at biopsy(5 years)
- Needle targeting accuracy(5 years)
- Procedure time(Up to 30 minutes)
- Sensitivity of detecting clinically significant prostate cancer at biopsy(5 years)
- Specificity of detecting clinically significant prostate cancer at biopsy(5 years)
