About this trial
Over 20,000 patients a year in the UK get surgery or radiotherapy to cure their prostate cancer. These men then undergo regular check-ups to manage potential side effects and see if cancer recurs so it can be treated quickly. The organisation of these check-ups varies across the country as it is not known which approach is best. The four different established approaches are (i) check-ups performed in hospital outpatients by the same team that provided treatment; (ii) patients seen regularly by their GP with hospital referral as necessary; (iii) planned shared care between general practice and hospital follow up; or (iv) patients supported to provide checks on themselves (self-care) and reaching out to a doctor or a nurse when required. This study will compare these options to establish which is best for patients and makes the best use of the NHS resources.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having newly-diagnosed non-metastatic, clinically localised prostate cancer (ICD-10 code C61) in the Cancer Registry between 1 January 2018 and 31 December 2023;
Age 18 or over at diagnosis;
Completed primary curative treatment at an eligible hospital between 1 January 2019 and 31 December 2023 with either: radical radiotherapy +/- hormones, or radical prostatectomy with curative intent +/- lymphadenectomy, or focal therapy, in keeping with local practice;
Alive with no disease progression or metastasis 6 months after the date of completion of primary curative treatment.
Disqualifiers
Men who are treated for metastatic cancer; or receiving palliative prostate cancer care;
Men who have opted out of their data being used as part of national routine data sets will be excluded (https://digital.nhs.uk/services/national-data-opt-out).
Alive;
Have achieved between three to four and a half years of follow up (from completion of initial curative treatment) during the survey period.
Trial population
Men aged 18 and over who were newly diagnosed with prostate cancer between January 2018 and December 2023 and completed curative treatment to cure their prostate cancer at a hospital in England between January 2019 and December 2023.
Trial design
Cohort
Prospective
Treatments tested in this trial
Hospital based follow up
Other interventionExclusively hospital led follow up, face-to-face or remotely by the specialist treating team.
Primary care based follow up
Other interventionAfter the initial hospital follow up, patients are discharged and exclusively managed by (non-specialist) general practices (GP or nurse led) in face-to-face or remote appointments, with hospital referral as necessary.
Planned shared care follow up
Other interventionAn ongoing combination of general practice and hospital management
Self-management
Other interventionAfter initial hospital follow up, patients are discharged and managed remotely, with no scheduled review. A tracking system monitors prostate-specific antigen (PSA) tests performed in primary care or secondary care. Patients access support workers for remote consultation to discuss symptoms and request further specialist management as required.
Treatment groups
Trial outcomes
Primary outcomes
Safety and clinical effectiveness defined by treatment for cancer recurrence
Probability of cancer recurrence treatment calculated from analysis of time to recurrence treatment, measured using Hospital Episode Statistics (HES)-linked cancer databases and patient survey that includes domains on cancer recurrence and treatment.
Estimate cost-effectiveness
Modelled cost-effectiveness reported as incremental cost per quality adjusted life year (QALY) gained at different points over patient lifetime from an NHS and personal social services perspective, measured using HES-linked databases and patient survey
Secondary outcomes
Time to treatment for cancer recurrence provided in secondary care
Restricted mean time to treatment for cancer recurrence provided in secondary care, measured using HES-linked databases.
Metastases, cancer specific and overall survival
Time to metastasis, time to prostate cancer specific death, and overall survival (including time to and cause of non-prostate cancer deaths), measured using HES-linked databases
Cancer recurrence treatments (salvage to cure vs palliative suggesting delayed diagnosis)
A binary outcome (cancer recurrence treatment) that takes the value 1 if the recurrence treatment was salvage with intent to cure and 0 if the recurrence treatment was palliative. This will be assessed using the type of first treatment received for recurrence, as recorded in HES-linked databases or reported in the patient survey.
Health related quality of life (HRQoL)
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument will be used to measure HRQoL in the patient survey. The EQ-5D-5L index values range from a minimum of -0.594 (representing health states considered worse than death) to a maximum of 1.000 (representing full health). In this scoring system, higher values indicate better health-related quality of life outcomes.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborator
University of Aberdeen
Collaborator
University of Leeds
Collaborator
Cardiff University
Collaborator
University of Sheffield
Collaborator
University of Southampton
Collaborator
University College, London
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
North Bristol NHS Trust
Collaborator
Cardiff and Vale University Health Board
Collaborator
Liverpool University Hospitals NHS Foundation Trust
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
This trial is not recruiting at the moment. You can still explore other options: