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临床试验/NCT02871726
NCT02871726招募中不适用

Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 483 人开始时间: 2021年11月24日最近更新:
适应症
干预措施

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

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

Experimental

TRUS and TRUS-Robot will be used during prostate biopsy

干预措施: TRUS-Robot (Device)

TRUS-Robot and TRUS

Experimental

TRUS and TRUS-Robot will be used during prostate biopsy

干预措施: TRUS biopsy (Other)

Routine TRUS/Fusion biopsy

Active Comparator

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)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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