Prostate cancer Cancer
Conditions
Interventions
In this multi-arm multi-stage randomised platform trial, eligible men will be invited via their GP practice for a community-based screening intervention. The trial will involve two stages. In Stage 1
Sponsors
Imperial College London
Eligibility
Sex/Gender
Male
Age
45 Years to 74 Years
Inclusion criteria
Inclusion criteria: Stage 1: 1. Men in the general population aged 50-74 years. 2. Additionally, men aged 45-49 years who self-identify in GP practice lists as of Black ethnicity. 3. Additionally, men aged 45-49 years who are on the GP learning disability Quality Outcome Framework (QOF) register.
Exclusion criteria
Exclusion criteria: 1. History of prostate cancer (clinical diagnosis or histological). 2. Known history of one or more PSA tests, prostate MRI scans, prostate biomarker tests or prostate biopsies in the preceding 5 years. 3. Urinary tract infection in the 3 months before screening. 4. Significant co-morbidities or other cancers likely to impact their life expectancy in the next 10 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1: Feasibility outcomes 1. Proportion who receive the Prostate Health Check (PHC) in each screening intervention arm (Design 1 and Design 2, separately) at the end of the trial 2. Proportion with PSA test in each of the control groups (Design 1 and Design 2, separately) measured through linkage to national databases at the end of the trial Stage 1: Prostate health checks intervention pilot outcomes In each PHC group: 1.Proportion diagnosed with intermediate-risk prostate cancers (NCCN*) [also collected in control groups] at the end of the trial 2.Proportion diagnosed with low-risk prostate cancers (NCCN*) [also collected in control groups] at the end of the trial 3.Proportion having a prostate biopsy [also collected in control groups] at the end of the trial 4.Costs and cost-effectiveness modelling of each PHC intervention (from first visit to diagnosis/treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage 1: feasibility outcomes: 1. Proportion who provide Stage 1 consent (Design 1) 2. Proportion with Black ethnicity invited (Designs 1 and 2 combined) 3. Cost per successful consent (Design 1 and Design 2 separately): 4. Proportion who provide Stage 1 consent (Design 1) by age group, ethnicity, IMD quintile 5. Proportion of men with learning disability or severe mental illness who provide Stage 1 consent (Design 1) 6. Proportion undergoing PHCs in each screening intervention arm by age, ethnicity, IMD quintile (Design 1) 7. Performance indicators, including compliance with further assessment and compliance with treatment Stage 1: prostate health checks intervention pilot outcomes: In each randomised PHC group: Timelines: Time (days) from randomisation to a) undergoing the first part of each PHC to b) receiving the result of the first test to c) undergoing Prostagram™ to d) receiving the result of the Prostagram™ to e) having a prostate biopsy in those advised to undergo a prostate biopsy Detection: 1. Proportion diagnosed with high-risk prostate cancers (NCCN*) 2. Proportion diagnosed with low/intermediate/high-risk prostate cancer according to NICE risk groups* (* based on Cambridge Prognostic Group, low-risk = CPG1, intermediate-risk = CPG2-3, high-risk = CPG4-5, ref: ww.nice.org.uk/guidance/ng131) 3. Proportion diagnosed by ISUP Grade Group: GG1, GG2, GG3, GG4, GG5 prostate cancer 4. Proportion diagnosed by T stage 5. Proportion diagnosed with any amount of Gleason 4+3=7 or more 6. Proportion diagnosed with = Gleason 4+3 OR Gleason 3+3=6 of =6mm (PROMIS definition 1) 7. Proportion diagnosed with = Gleason 3+4 OR Gleason 3+3=6 of =4mm (PROMIS definition 2) 8. Proportion of GG2 cancers in each of the following categories of percentage pattern 4 involvement: =10%, 11-20%, 21-30%, 31-40%, 41-50% In those diagnosed with prostate cancer: 1. Maximum cancer length on biopsy in millimetres 2. Gleason Score Ratio of GS6 to GS7+ 3. Proportion with lymph node cancer | — |
Countries
England, United Kingdom
Outcome results
None listed