Identifying the Best Follow up Approach for People Who Have Had Treatment to Cure Newly Diagnosed Prostate Cancer

NCT07264088 | Not Yet Recruiting

• 5 other identifiers: 181848NIHR15037634236225/LO/075325_CAG_0127
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate cancer after curative treatment; prostate cancer follow up; propensity-matched cohort study; qualitative; discrete choice experiment; economic evaluation; routine data; patient survey

Outcome Measures

Primary Outcomes (2)

• 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.

  At 3 years following end of initial radical surgery or radiotherapy or focal therapy

• 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

  At 3 years, extrapolated over the remaining patient lifetime

Secondary Outcomes (10)

• Time to treatment for cancer recurrence provided in secondary care

  Up to 7 complete years following end of initial radical surgery or radiotherapy or focal therapy

• Metastases, cancer specific and overall survival

  Up to 7 complete years following end of initial radical surgery or radiotherapy or focal therapy

• Cancer recurrence treatments (salvage to cure vs palliative suggesting delayed diagnosis)

  Up to 3 years following end of initial radical surgery or radiotherapy or focal therapy

• Health related quality of life (HRQoL)

  At 3 to 4.5 years following end of initial radical surgery or radiotherapy or focal therapy

• Health related quality of life (HRQoL)

  At 3 to 4.5 years following end of initial radical surgery or radiotherapy or focal therapy

Study Arms (4)

Hospital based follow up

Exclusively hospital led follow up, face-to-face or remotely by the specialist treating team.

Other: Hospital based follow up

Primary care based follow up

After 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.

Other: Primary care based follow up

Planned shared care follow up

An ongoing combination of general practice and hospital management

Other: Planned shared care follow up

Self-management

After 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.

Other: Self-management

Interventions

Hospital based follow up OTHER

Exclusively hospital led follow up, face-to-face or remotely by the specialist treating team.

Hospital based follow up

Primary care based follow up OTHER

After 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.

Primary care based follow up

Planned shared care follow up OTHER

An ongoing combination of general practice and hospital management

Planned shared care follow up

Self-management OTHER

After 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.

Self-management

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Recruitment to the survey component of the study will be limited to a sub-cohort of eligible participants that additionally meet the following criteria:
• Alive;
• Have achieved between three to four and a half years of follow up (from completion of initial curative treatment) during the survey period.

Sponsors & Collaborators

• 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
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Imperial College London: lead
• Cardiff and Vale University Health Board: collaborator

Study Sites (1)

London School of Hygiene & Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rakesh Heer, BMed Sci MB BS MRCS PhD FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Johnson, BSc (Hon)

CONTACT

+44 (0) 1224 438144; followup@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 4, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

GB (1)