Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of high resolution ultrasound
研究概览
简要总结
The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference.
详细描述
The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference. The analysis will include the detection of all prostate cancer lesions as well as the detection of significant prostate cancer lesions. With this approach it is possible to calculate the sensitivity, specificity, negative predictive value, positive predictive value and overall accuracy of the correct detection of prostate cancer in the prostate. These results are of importance when the ExactVu ultrasound scanner is to be used later for prostate cancer diagnosis using targeted biopsies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men > 35 years age and <80 years of age
- •diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy
- •staging by standard procedures show localized disease (<cT4)
- •PSA < 50ng/ml
- •Access to the rectum for trans rectal ultrasound
- •Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
- •Signed written informed consent prior to any screening procedures being performed
排除标准
- •Patient with absence of diagnosis of prostate cancer
- •Patient with metastatic prostate cancer
- •Patient with rectal amputation
- •Patient with contraindications for MRI
- •Patient in urgency situation, adult under legal protection, or unable to give his consent.
结局指标
主要结局
Diagnostic accuracy of high resolution ultrasound
时间窗: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
rate of adequately identified (positive or negative) lesions of prostate cancer
次要结局
- Morphology of lesions not detected by high-resolution ultrasound(From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days))
- Localization of lesions not detected by high-resolution ultrasound(From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days))
- Extra-prostatic extensions detected by high-resolution ultra-sound(From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days))
- Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer.(From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days))