Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Strategy 1 - Participants recruited via the GP practices. An existing database of participating GP practices will be searched to identify potential participants. The latter will be sent a personalised
Sponsors
University College London
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 1. For LI-MRI the presence of a suspicious lesion in LI-MRI reporting 2. For bp-MRI the presence of a suspicious lesion in bp-MRI reporting 3. For PSA density this is a test result of 0.12 ng/ml or more All are calculated as part of the study analysis when all data is collected | — |
Secondary
| Measure | Time frame |
|---|---|
| All are calculated as part of the study analysis when all data is collected: 1. The uptake of screening invitation and MRI-based screening tests: 1.1. The proportion of men attending screening who complete one or more MRI tests for each individual strategy 1.2. Descriptive analysis of recruitment 1.2.1. In each strategy (GP recruitment vs community recruitment) 1.2.2. Across each participating site (London, Cambridge and Manchester) 1.2.3. By ethnicity 1.2.4. Comparison of percentage recruitment by ethnic groups for GP vs community recruitment 1.3. Time to completion of recruitment pathway in each strategy 2. The acceptability of screening procedures: 2.1. Quantitative assessment across all participants, define participant acceptability 2.2. In-depth qualitative assessment of acceptability in a randomly selected sub-sample of participants, GPs, urologists, radiographers and commissioners aiming to access a broader range of views of the process and confirm GP’s acceptability of communication of results and management plan and urologists’ referral pathway (within trial study) 3. The net benefit of screening with each test based on the number of men identified with clinically significant cancer, taking into account the number of men undergoing biopsy who are found not to have significant cancer 4. The prevalence of LI-MRI-defined suspicious lesions with subsequent confirmed presence of clinically significant cancer by recruitment 4.1. In each strategy (GP recruitment vs community recruitment) 4.2. Across each participating site (London, Cambridge and Manchester) 4.3. By ethnicity 5. For LI-MR, abbreviated bp-MRI and PSA density, individual assessment of: 5.1. Diagnostic yield of clinically significant cancer, based on the percentage of significant cancers according to referral and uptake of urologist appointment and further testing (mpMRI, biopsy) 5.2. Reading time (LI-MRI and bp-MRI only) | — |
Countries
England, United Kingdom
Outcome results
None listed