A feasibility study inviting men for prostate cancer screening using a new short scan, a usual practice scan and a blood test, to identify men at risk of cancer and to measure the acceptability of these methods
Not Applicable
- Conditions
- Prostate cancerCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN45191339
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Male
- Target Recruitment
- 800
Inclusion Criteria
1. Men aged 50-75 years
2. No prior prostate cancer diagnosis/treatment
3. Willing and able to provide a written informed consent
Exclusion Criteria
1. Previous diagnosis of prostate cancer
2. Contraindication to MRI scan (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)
3. Men who require assisted living e.g. care home living
4. Lacks the capacity to consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The prevalence of men with a test result (LI-MRI, bpMRI or PSA density) requiring referral for suspicion of prostate cancer at 3 years. This is equivalent to the recall rate for screening. Test result that triggers referral is defined in the analysis as<br>1. For LI-MRI the presence of a suspicious lesion in LI-MRI reporting<br>2. For bp-MRI the presence of a suspicious lesion in bp-MRI reporting<br>3. For PSA density this is a test result of 0.12 ng/ml or more<br>All are calculated as part of the study analysis when all data is collected
- Secondary Outcome Measures
Name Time Method