CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 299
- 试验地点
- 2
- 主要终点
- per-patient (significant) prostate cancer detection rate of systematic biopsies
研究概览
简要总结
The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the one hand and underdiagnosis and undergrading of significant PCa on the other. multiparametric Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the clinics for biopsy targeting, but the value in biopsy naive patients remains controversial. With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. To overcome these difficulties CEUS quantification techniques have been used with encouraging first results. These imaging techniques have been proposed to improve the yield of prostate biopsies and possibly replacing systematic biopsies.
In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy. Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS lesions, together with standard systematic biopsies in the same patients by separate blinded clinicians. The main outcome measure is the per-patient (significant) prostate cancer detection rate for each of the biopsy regimens.
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
- •age ≥ 18 years
- •signed informed consent
- •referred for mpMRI and primary biopsy
排除标准
- •Documented acute prostatitis or urinary tract infections
- •History of any clinically evidence of cardiac right-to-left shunts
- •Receives treatment that includes dobutamine
- •Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- •Has received a biopsy procedure within 30 days before admission into this study
- •Has received a biopsy procedure at the Academic Medical Center within a year before admission into this study
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
- •Is incapable of understanding the language in which the information for the patient is given
研究组 & 干预措施
Single Arm
every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control.
干预措施: CEUS and targeted biopsies (Other)
Single Arm
every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control.
干预措施: MRI and targeted biopsies (Other)
结局指标
主要结局
per-patient (significant) prostate cancer detection rate of systematic biopsies
时间窗: 2 weeks
per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies
时间窗: 2 weeks
per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies
时间窗: 2 weeks
次要结局
- complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate(2 weeks)
研究者
Prof. dr. ir. H. Wijkstra
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
