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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorImperial College London

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hospital based follow up

    Other intervention

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

  • Primary care based follow up

    Other intervention

    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.

  • Planned shared care follow up

    Other intervention

    An ongoing combination of general practice and hospital management

  • Self-management

    Other intervention

    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.

Treatment groups

100,000 Participants
are divided into 4 treatment groups
Group A: Hospital based follow up1 intervention
Group B: Primary care based follow up1 intervention
Group C: Planned shared care follow up1 intervention
Group D: Self-management1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 3 years following end of initial radical surgery or radiotherapy or focal therapy
2

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

Time frame
At 3 years, extrapolated over the remaining patient lifetime

Secondary outcomes

1

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.

Time frame
Up to 7 complete years following end of initial radical surgery or radiotherapy or focal therapy
2

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

Time frame
Up to 7 complete years following end of initial radical surgery or radiotherapy or focal therapy
3

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.

Time frame
Up to 3 years following end of initial radical surgery or radiotherapy or focal therapy
4

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.

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

Other 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: