Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml
研究概览
简要总结
To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.
详细描述
The Investigators propose a pilot study which utilizes bpMRI in conjunction with PSA in the early detection of clinically significant prostate cancer in a high-risk group. Our study would focus on these high-risk subjects between the ages of 40-55 with a normal PSA ranging from ≥1.0 to <2.5 ng/mL. bpMRI would be obtained in this group of subjects. If any suspicious lesions are found, the recommendation is to undergo MRI/US fusion biopsy. Subjects with negative bpMRI will be followed every year with serum PSA. Subjects with a positive bpMRI will have a prostate fusion and systematic biopsy performed. Those with a benign biopsy will be followed every year with serum PSA. Those who have a biopsy positive for cancer will be managed and followed according to the standard of care. All subjects will be followed for 5 years. Our hypothesis is that bpMRI in conjunction with above average PSA in a high-risk group will increase detection of clinically relevant prostate cancer and provide a useful addition to PSA screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PSA between 1.0 and 2.5 ng/dL
- •High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2
- •Patient is willing to participated in prostate cancer screening
- •Patient is capable of giving informed consent
排除标准
- •Nodularity or firmness of prostate on exam
- •Patient has undergone a prior biopsy or prostate surgery
- •Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.
- •Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.
- •Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies
- •Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
- •The participant cannot tolerate lying flat for the study duration
结局指标
主要结局
Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml
时间窗: 3 months
To determine the incidence of positive mpMRI prostate in a high-risk cohort of men as a screening tool for prostate cancer.
次要结局
- Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI(3 months)
- Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.(5 years)
- To correlate bpMRI findings with future changes in PSA(5 years)