CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of VERDICT MRI
研究概览
简要总结
To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself
详细描述
Patients will undergo an advanced diffusion-weighted MRI sequence called VERDICT with the intention of better characterising prostate cancer. A panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive MRI.
OBJECTIVES:
- To establish a fluidic marker - prostate MRI paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) MRI
- Enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes
- Assess the repeatability of VERDICT MRI
- Ascertain whether VERDICT derived quantitative parameters correlate with quantitative histological parameters
- Develop a database of fluidic marker and VERDICT characterised, mp-MRI, histologically validated patients for subsequent exploratory and longitudinal outcome analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men referred to University College London Hospital (UCLH) for prostate mp-MRI following biopsy elsewhere and biopsy naive men presenting to UCLH with a clinical suspicion of prostate cancer.
排除标准
- •Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
- •Men unable to given informed consent
- •Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
- •On-going hormonal treatment for prostate cancer
- •Previous biopsy within 6 months of scheduled mp-MRI
结局指标
主要结局
Diagnostic accuracy of VERDICT MRI
时间窗: 3 - 6 months (after targeted biopsy or follow up MRI)
Radiological assessment with added VERDICT MRI improves the specificity of mp-MRI for detection of significant prostate cancer by \>10% above standard multi-parametric MRI alone.
次要结局
未报告次要终点