Prostate Cancer Detection Using a Quantitative Screening MRI Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of Participants That Had Adverse Events
研究概览
简要总结
Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.
详细描述
This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology clinics. All eligible men will be screened and enrolled by the clinical research coordinator. Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC) prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation in pathology. Biopsy results will be communicated to the patients by the Urologist performing the biopsy and all additional management will be SOC. This visit will signify the end of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult men between 18 and 80 years of age
- •Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician
- •Ability to provide informed consent
排除标准
- •Prior prostate biopsy
- •Prior diagnosis of PCa
- •MRI incompatible implanted medical devices or foreign bodies
- •Rectal anatomy incompatible with TRUS biopsy
- •Life expectancy <10 years as determined by the treating urologist
结局指标
主要结局
Number of Participants That Had Adverse Events
时间窗: 19 months
Adverse events of prostate biopsy using the Clavien-Dindo scale
Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology
时间窗: 19 months
Per subject prevalence of any grade or high grade (Gleason score 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology
时间窗: 19 months
Per biopsy sample prevalence of high grade (Gleason 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Number of Participants With PI-RADS 4-5 on MRI
时间窗: 19 months
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Number of Participants With PI-RADS <4 MRI
时间窗: 19 months
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
次要结局
未报告次要终点
研究者
Michael R Abern
Principal Investigator
University of Illinois at Chicago