Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 852
- 试验地点
- 69
- 主要终点
- Risk prediction model
研究概览
简要总结
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer.
II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review.
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
- •Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated
排除标准
- •Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
- •Prior surgical and/or non-surgical treatment for prostate cancer
- •Prior hip replacement or other major pelvic surgery
研究组 & 干预措施
Diagnostic (mpMRI)
Patients undergo mpMRI within 3 months prior to schedule surgery.
干预措施: Multiparametric Magnetic Resonance Imaging (Diagnostic Test)
结局指标
主要结局
Risk prediction model
时间窗: Up to 2 years
To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage.
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score
时间窗: Up to 2 years
Will estimate the diagnostic performance as quantified by the area under the ROC curve.
次要结局
- Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score(Up to 2 years)