ReIMAGINE Prostate Cancer Screening - Inviting Men for Prostate Cancer Screening Using MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Presence of cancer in men who have biopsy as a result of their MRI findings
研究概览
简要总结
Single site study to assess the feasibility of prostate cancer screening using an invitation for a prostate MRI scan via GP practices. This feasibility study will assess the acceptability of an MRI as a prostate cancer screening assessment and assess the prevalence of MRI defined suspicious lesions and cancer in men across a spectrum of PSA results.
详细描述
ReIMAGINE Prostate cancer screening is a single site screening study to assess the feasibility of MRI as a screening tool for prostate care and determine the prevalence of MRI defined suspicious lesions and cancer in men across a spectrum of PSA results.
Men with no previous prostate cancer diagnosis, but deemed suitable based on age will be identified through general practitioner (GP) practices who will act as participant identification centres (PIC's). Potential participants will be identified through screening of existing patient databases at multiple London GP surgeries participating in the study, and randomly selected for invitation. The ReIMAGINE study team will link with London cancer networks and Noclor research support (https://www.noclor.nhs.uk/) who will make first contact with potentially eligible men.
A personalised invitation letter from each man's own GP will be sent to him. Invitation letters will be sent in batches so to limit the time between the invitation and their study visit. Batched invitations will be prepared using an iterative process so to allow the study team to assess uptake rates and limit the gap between invitation and study visits.
Invitation letters will include contact details for the ReIMAGINE study team who will coordinate bookings for research visits for all responders.
All consented men will have a blood test for PSA and a screening MRI scan. This will take a maximum of 20 minutes, and will include T2, diffusion and research specific sequences.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 50-75
- •No prior prostate cancer diagnosis / treatment
- •Willing and able to provide written informed consent.
排除标准
- •Contraindication for MRI scanning (as assessed by the MRI safety questionnaire of the PET/MRI department) which includes but is not limited to: Intracranial aneurysm clips or other metallic objects; Intra-orbital metal fragments that have not been removed; Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves; Inner ear implants; and History of claustrophobia
- •Men who require assisted living e.g. care home living
- •Dementia or other neurological condition meaning participant lacks the capacity to consent.
结局指标
主要结局
Presence of cancer in men who have biopsy as a result of their MRI findings
时间窗: 3 years
The prevalence of men being diagnosed with prostate cancer who have biopsy as a result of their MRI findings
The acceptance rate of an invitation for a screening prostate MRI in men who have not had a prostate cancer diagnosis
时间窗: 3 years
Proportion of men who accept the invitation for prostate screening
The prevalence of MRI defined suspicious lesions in men accepting a screening invitation
时间窗: 3 years
The prevalence of MRI defined suspicious lesions in men accepting a screening invitation
次要结局
- The proportion of men who screen positive on MRI alone(3 years)
- The proportion of men who screen negative on MRI(3 years)
- The proportion of men ineligible due to prior prostate cancer diagnosis(3 years)
- The proportion of men who screen positive on PSA density alone(3 years)
- The proportion of men who screen negative on PSA density(3 years)