The FOLLOW UP study - a natural experiment estimating the clinical and cost-effectiveness of follow up strategies after curative treatment for prostate cancer.
Every year, over 20,000 men in the UK finish surgery or radiotherapy for prostate cancer, then enter a patchwork of follow-up care that no one knows is best. This matters because the four existing follow-up strategies—hospital outpatient visits, GP-led checks, shared care, or patient self-management—vary wildly across the country. Without evidence, hospitals and GPs cannot know which approach safely catches recurrences, manages side effects, and uses NHS money wisely. The study will compare these strategies using routine NHS data from men treated between 2018 and 2023, plus patient surveys and interviews. If successful, the research will give the NHS a clear, cost-effective follow-up protocol. That could free up hospital capacity, reduce unnecessary appointments for patients, and ensure recurrences are caught early enough for curative treatment rather than palliative care. The findings will directly reshape how thousands of men are monitored each year, improving quality of life while saving the health service money.
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QUESTION What is the most clinical & cost-effective follow-up strategy after curative treatment for prostate cancer? BACKGROUND 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 we do not know 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 General Practitioner (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. Our study will compare these options to establish which is best for patients and makes the best use of NHS resources. OBJECTIVES 1. Primary objectives: Compare each follow up strategy against control (hospital follow up) for (i) safety and clinical effectiveness defined by treatment for cancer recurrence, and (ii) estimate cost-effectiveness. 2. Secondary objectives: Compare each follow up protocol against control (hospital follow up) for (i) time to treatment for cancer recurrence provided in secondary care; (ii) metastases and cancer specific and overall survival; (iii) cancer recurrence treatments (salvage to cure vs palliative suggesting delayed diagnosis); (iv) health related quality of life (HRQoL); (v) physical and psychological complications of treatment; (vi) prostate cancer core outcome set; (vii) patient experience and satisfaction; (viii) adherence to follow up strategy and (ix) costs to health services. METHODS 1. Design: Pragmatic, prospective propensity-matched cohort study using routine data, with an embedded patient survey, economic evaluation, qualitative interview study and discrete choice experiment. Individual sites will be grouped according to one of the four follow-up strategies to compare outcomes in a natural experiment. 2. Health technology: hospital based, primary care based, planned shared care, and self-management follow-up. 3. Population: All hospitals in England that provide radical prostatectomy or radical radiotherapy or focal therapy for prostate cancer and are identified by clinicians as receiving one of the four follow up strategies of interest. Individual patient inclusion: (i) newly-diagnosed non-metastatic, clinically localised prostate cancer in the Cancer Registry between 1 January 2018 and 31 December 2023; (ii) age 18 or over at diagnosis; (iii) 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; (iv) alive with no disease progression or metastasis 6 months after the date of completion of primary curative treatment. Excluded: (i) men who are treated for metastatic cancer or receiving palliative cancer care; (ii) men who have opted out of their data being included in national routine data sets. OUTCOME MEASURES: (a) Primary outcomes: (i) probability of cancer recurrence treatment at 3 years after curative intent (from HES-linked databases & patient survey) & (ii) modelled cost-effectiveness reported as incremental cost per QALY gained at different time points over patient lifteime (from HES-linked databases and patient survey). (b) Secondary outcomes: (i) mean time to treatment for cancer recurrence provided in secondary care up to 7 complete years after curative treatment (from HES-linked databases); (ii) time to metastasis; prostate cancer-specific death and overall survival at up to 7 complete years from curative treatment (from HES-linked databases); (iii) type of cancer recurrence at
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