Transrectal Ultrasound Robot-Assisted Prostate Biopsy

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство TRUS-Robot
  A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
• Другое TRUS biopsy
  Uronav for prostate biopsy.

Первичные конечные точки

• Cancer Detection Rate of Clinically Significant Prostate Cancer [Срок оценки: 5 years]
• Investigational device serious adverse events [Срок оценки: 5 years]
• Cancer Detection Rate of Clinically Insignificant Prostate Cancer [Срок оценки: 5 years]

Вторичные конечные точки (5)

• Needle targeting accuracy [Срок оценки: 5 years]
• Procedure time [Срок оценки: Up to 30 minutes]
• Sensitivity of detecting clinically significant prostate cancer at biopsy [Срок оценки: 5 years]
• Specificity of detecting clinically significant prostate cancer at biopsy [Срок оценки: 5 years]
• Predictive rates of detecting clinically significant prostate cancer at biopsy [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Scheduled for an initial diagnostic biopsy
• Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Johns Hopkins Hospital — Baltimore

Идентификаторы

NCT: NCT02871726 · IRB00068488

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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