Information intended for UK healthcare professionals only.
This promotional supplement has been commissioned and funded by Ipsen UK Ltd and developed in partnership with Guidelines in Practice. See below for full disclaimer.
Alcorn J, Cross E, Forrer J, Heer R, Holmes P, Jones R, Mills S, Sayers I, Warren T, Williams N
Exploring decisions surrounding the optimisation of Androgen Deprivation Therapy (ADT) use for appropriate prostate cancer (PCa) patients in the NHS in light of COVID-19 via a peer-led consensus approach
Prostate cancer (PCa) is the most common male cancer and the second most common cancer overall in the UK.1 There are around 48,500 new PCa diagnoses in the UK every year, with the highest incidence rates in males aged 75–79. Five-year survival rates are high with almost 9 in 10 (86.6%) surviving for five years or more and it is predicted that almost 8 in 10 (77.6%) survive for at least ten years after diagnosis.2
There are a range of surgical and non-surgical treatments for prostate cancer, depending on how far the cancer has spread. Low-risk localised prostate cancer is usually managed with active surveillance. Intermediate- and high-risk localised prostate cancer can be treated with surgery alone or radiotherapy with adjuvant androgen deprivation therapy (ADT). The prostate gland is heavily reliant on testosterone for growth and function and ADT may decrease the size of tumour and metastases. The higher the risk of apparently localised prostate cancer having spread the longer ADT is usually given for. Metastatic hormone sensitive PCa is typically treated with chemotherapy and long-term ADT.3 Typically, long-term ADT is given for metastatic disease.1
After radical treatment or chemotherapy, patients in the UK may be discharged into primary care for monitoring and administration of long-term ADT injections.4,5
For ADT, luteinising hormone releasing hormone (LHRH) agonists are the most commonly used treatment option. Provision of ADT to patients often involves administration of the selected LHRH agonist either as subcutaneous or intramuscular injection. This needs to be prepared and delivered by a healthcare professional with relevant experience in a healthcare setting usually at a frequency of either 1, 3 or 6-monthly intervals. Over a longer period of time this involves considerable variation in provider resource and number of visits to a healthcare setting that are required by the patient. Additionally, unilateral selection of treatment approach by the care provider may influence patient satisfaction and/or engagement with their treatment. In order to manage the ADT regimen, effective systems of recall to ensure continuous therapy is delivered over time are also an important factor.
The COVID-19 pandemic necessitated a radical redeployment of NHS resource in order to meet the dual challenge of caring for the huge increase in demand for care, whilst at the same time employing measures to mitigate the risk of transmission. Cancer screening programmes were paused, GP appointments were disrupted or put off by concerned patients and staff were reallocated away from cancer services, and in some cases, cancer treatment was paused for some individuals.6
In the UK, national COVID-19 pandemic measures have resulted in the suspension of cancer screening and deferral of routine diagnostic investigations. Urgent 2-week wait referrals from GPs for patients with suspected cancer have decreased by up to 80%.7
As a consequence of COVID-19, it is estimated that over 650,000 people with cancer in the UK have experienced disruption to their cancer treatment or care, and that by October 2021, the diagnostic backlog for cancer will be over 100,000.6 It is clear that cancer services will be under pressure to manage the backlog and maintain care for those receiving treatment. To achieve this there is an opportunity to apply new models of care developed in response to the pandemic but that can be used to reduce capacity burden and provide quality care for PCa patients. The practicalities of minimising the risk of COVID-19 have driven a greater consideration amongst the healthcare community of the frequency of treatment injections.8–10 Pressures on clinical teams’ capacity in primary and secondary care are significant and the pandemic has exacerbated this. Future care may be based around the minimisation of face-to-face contact between patients and clinicians (where achievable without detriment to patient care) as:
- Living with endemic COVID-19 and its risks will become the de facto norm
- As the population ages and obesity rates continue to climb, the numbers of patients living with multiple long-term conditions will also increase
This project was initiated to provide insight into how ADT can be optimally delivered both during and after the COVID-19 pandemic, to maximise both the efficiency of prostate cancer services and associated patient outcomes.
The objectives of this project are to understand the attitudes of clinicians regarding the optimisation of ADT from across the UK and define a clear consensus from a large sample of respondents. This will provide clarity on the specific considerations required in the approach to PCa management in light of the COVID-19 pandemic.
In pursuing these objectives, this group intends to understand attitudes and identify challenges within it so that clear calls-to-action may be defined. This may help to support alignment between the views of various roles and regions of the UK and inform practice in managing PCa with ADT.
A UK expert-steering group commissioned by Ipsen met in February 2021 to review the current landscape and identify and agree key domains in the PCa care pathway.
The steering group members were:
- Jason Alcorn, Lead Uro-Oncology Nurse
- Liz Cross, Advanced Nurse Practitioner
- Jim Forrer, General Practitioner
- Rakesh Heer, Consultant Urologist
- Patrick Holmes, General Practitioner
- Richard Jones, Programme Director (Medicines Optimisation)
- John Logue, Consultant Clinical Oncologist
- Susan Mills, Pharmacist & Mentor to PCN Pharmacy
- Ian Sayers, Consultant Oncologist
The key domains agreed by the Steering Group were:
A. Appropriate prioritisation of prostate cancer services in the NHS
B. Managing risk for patients with PCa engaging with the NHS
C. Optimising the care pathway
D. Initiation & optimisation of ADT therapy
These domains were each further discussed to generate consensus statements for testing across a wider audience of healthcare professionals (HCPs) involved in PCa care. Consensus statements (n=33) were then constructed to provide insight into UK practice. The statements were collated into a questionnaire, which was sent to relevant HCPs (Urologists, Oncologists, GPs, Nurses and Hospital Pharmacists). The responses to consensus statements were analysed in line with DelphiTM methodology.11 The DelphiTM approach involves a group of experts who anonymously reply to questionnaires (in this case agreed by the Steering Group), the results are then analysed and if consensus agreement is not reached, the questionnaire may be refined and the process repeated until consensus is reached. The goal is to reduce the range of responses and arrive at something closer to expert consensus.
As part of the data analysis, the group wished to compare patterns of response from different roles and regions of the UK, so the questionnaire captured role and region (England, Scotland, Wales, Northern Ireland)
Respondents were offered a 4-point Likert scale to rate their agreement with each statement, ranging across ‘strongly disagree’, ‘tend to disagree’, ‘tend to agree’ and ‘strongly agree’. Completed questionnaires were collated and the individual scores for each statement analysed in order to produce an arithmetic agreement score for each. The responses were broken down further by role and UK region to identify any variance in the respondent’s agreement scores. The majority of the responses were from England (245/277; Figure 1).
The Steering Group predefined agreement for consensus at 75%, a widely accepted threshold.12 Consensus was defined as ‘high’ at ≥75% and ‘very high’ at ≥90%. Further rounds of questionnaire distribution were considered in line with DelphiTM methodology, but due to the high levels of agreement with all but two of the 33 statements, the Steering Group elected to work with the original responses to the statements.
Figure 1. Respondents by region (n=277)
Figure 2. Respondents by role
Completed questionnaires were returned by 277 UK respondents and analysed to define the total level of agreement with each of the 33 statements. Table 1 and Figure 3 show the statements and corresponding agreement levels.
Table 1. Consensus statements and agreement scores
|Domain A: Appropriate prioritisation of prostate cancer services in the NHS|
|1||There are sufficient resources available in the NHS to deliver the latest 2019 NICE Guidance||75%|
|2||Prostate cancer services should not continue to be deprioritised due to COVID-19||84%|
|3||Implementation of survivorship care plans that rely on delivery of well co-ordinated multidisciplinary care (e.g., medical, nutritional, psychosocial) improve the quality of life and the outcomes for patients with prostate cancer taking androgen deprivation therapy||97%|
|4||Survivorship care plans (i.e., those that rely on delivery of well co-ordinated multidisciplinary care e.g., medical, nutritional, psychosocial) should be available across the NHS||96%|
|5||Despite NICE guidelines there is significant variation in the delivery of prostate cancer services across the NHS||81%|
|6||There is significant variation in outcomes of patients with prostate cancer across the NHS||73%|
|Domain B: Managing risk for patients with PCa engaging with the NHS|
|7||The individual risk of COVID-19 should be stratified according to characteristics of the prostate cancer patient||95%|
|8||Clearer information is required for patients to understand the risk of not engaging with ongoing prostate cancer treatment and management versus the risk posed by COVID-19||95%|
|9||Consistent information should be provided to patients with prostate cancer about managing risk associated with COVID-19 when engaging with the NHS to avoid local variation||95%|
|10||The frequency of visiting a NHS healthcare site should be minimised to reduce the risk of COVID-19, but should not compromise prostate cancer patient outcomes||93%|
|11||The time and location of the visit for patients with prostate cancer should be planned to reduce the risk of COVID-19 infection||92%|
|12||PSA level tracking should be maintained during the pandemic with careful consideration of the risks and benefits to patients and providers||94%|
|13||The frequency of visiting a healthcare setting to receive delivery of androgen deprivation therapy should be minimised to address limited clinical capacity within NHS prostate cancer services||77%|
|Domain C: Optimising the care pathway|
|14||There is an increasing role for remote (e.g., telephone) consultations with prostate cancer patients||97%|
|15||Remote (e.g., telephone) consultations are not suitable for all prostate cancer patients||83%|
|16||The opportunity for a centralised, digitally-based clinical assessment resource for PSA testing should be available to all Acute NHS Trusts||93%|
|17||The opportunity for a centralised, digitally-based clinical assessment resource for PSA testing should be funded by the NHS||94%|
|18||In the setting that I work (e.g., primary care, secondary care etc.), there is a robust recall system to ensure blood tests (e.g., PSA, testosterone) and ADT injections are not missed||67%|
|Domain D: Initiation & optimisation of ADT therapy|
|19||Patients should be involved in the decisions around the initiation and optimisation of ADT||98%|
|20||When selecting ADT, the type (size) of needle is important for patients and should be considered||79%|
|21||When selecting ADT, the frequency of administration is important for patients and should be considered||95%|
|22||When selecting androgen deprivation therapy, the safety profile should be considered||99%|
|23||Appropriate information should be provided to patients with prostate cancer to help with choice of ADT||97%|
|24||Patients should be informed about possible side effects of ADT (e.g., hot flushes, impaired sexual function) and ways to manage these||98%|
|25||The practical differences (e.g., preparation requirements, needle size, method of administration, frequency of administration) associated with administering the available ADT options have an impact on HCPs delivering them and may influence clinical choice||84%|
|26||Appropriate use of injectable options with a lower frequency of administration required (e.g., 3-monthly, 6-monthly) supports a reduction in the frequency of patient visits to a healthcare setting||97%|
|27||Appropriate use of injectable options with a lower frequency of administration would help improve the capacity limitations of the associated healthcare team||96%|
|28||Decisions on choice of ADT should not be dependent on drug acquisition cost alone||88%|
|29||Future ADT guidance should include choice, including the role of lower frequency dosing regimens||95%|
|30||The awareness and understanding of injectables requiring less frequent administration should be increased in primary care||96%|
|31||The awareness and understanding of injectables requiring less frequent administration should be increased in secondary care||90%|
|32||Secondary care should be able to provide guidance on which ADT options should be offered in primary care||93%|
|33||The opportunity for patient self-administration of ADT should be pursued||88%|
Please note: statements 26 to 29, developed by the expert group discuss ‘treatments with ‘lower’ or ‘less’ frequency of administration’. This was understood to be based on the fact that usual options for ADT therapy are administered (in line with their licensed indications) either as 1-monthly 3-monthly or 6-monthly options. Patients receiving 3- monthly ADT therapies require lower / less frequent administration than 1-monthly options and patients receiving 6-monthly ADT therapies require lower / less frequent administration than either 1- or 3-monthly ADT options.
Figure 3: Consensus agreement by statement
NOTE: The green horizontal line represents the 75% threshold for consensus agreement, the red line shows the 33% agreement level, the blue line indicates the threshold for very high consensus (90%).
Domain A: Appropriate prioritisation of prostate cancer services in the NHS
All statements in Domain A achieved the agreement threshold for consensus with the exception of statement 6 (73%). Very high consensus was achieved in support of the use of survivorship care plans incorporating well-coordinated multidisciplinary care (97%) and that such plans should be available across the NHS (96%). As the UK emerges from the COVID-19 pandemic, those measures that were put in place to manage treatment and infection risk of COVID-19 should now be reviewed. With the focus shifting towards maintaining minimal infection risk while addressing a PCa backlog that has built up as a consequence of deprioritisation, ADT care delivery strategies will need to meet the dual objectives of maintaining minimal infection risk and making the most efficient use of a work force at significant risk of burnout. The NHS Reset campaign has been launched by NHS Confederation to shape what the health and care system should look like in the aftermath of the COVID-19 pandemic. The priorities include ‘best practice & innovation’ and ‘integration & whole system thinking’ which align with the objectives of this project. The outcomes of this campaign could help cancer services to address these challenges.13
Significant variation in the delivery of prostate cancer services is identified as an issue (81%), despite the publication of updated NICE guidelines in 2019.1 Evidence suggests that regional variation exists in patient-reported outcomes, even when adjusted for treatment, and clinical and sociodemographic factors.14 The National Prostate Cancer Audit (NPCA) has identified that more than one-third of men in England with high-risk or locally advanced prostate cancer do not receive radical local treatment. Factors associated with this potential ‘under-treatment’ include older age, increasing number of co-morbidities, higher socio-economic deprivation and Black ethnicity.15 There may be value in a NPCA audit into variation in PCa services in the post-pandemic period. These existing issues have the potential to become more acute as NHS priorities shift from tackling the pandemic to addressing the growing cancer backlog.
Domain B: Managing risk for patients with PCa engaging with the NHS
PCa is a progressive disease, and the diagnostic backlog created by the response to COVID-19 means that there is an urgent need to identify those men whose prostate cancers may cause them harm if not detected and treated. PCa symptoms are broadly non-specific (particularly in early disease) meaning that many men do not suspect that they may have cancer. Men may turn a blind eye to symptoms and risk factors where they exist, resulting in large numbers who do not respond quickly to symptoms of PCa.16 It is therefore important that local cancer services consider how to reach those men who may require investigation for PCa:
- Services need to consider how and why men present and link with primary care to ensure that there is a consistent approach to suspected PCa
- Primary Care Networks (PCN) should consider the employment of dedicated staff to help tackle the backlog
- Communications should use a multi-channel approach (i.e., direct mail, social media advertisements etc.) to reach men who require investigation
These initiatives should be funded under the ‘prevention’ agenda promoted by NHS England and which is a key focus of the NHS Long Term Plan.17
Of the seven statements in Domain B, six achieved very high levels of agreement (92–95%) with statement thirteen achieving 77%. HCPs agree that the risk of COVID-19 should be stratified to the individual patient and appropriate information provided in a consistent way to minimise this risk. The Steering Group would like to stress that patients should not be put off from seeking treatment for PCa due to COVID-19 and this should be communicated clearly. There was strong agreement (94%) from responders that PSA tracking should be maintained to provide critical diagnostic information for decision making in PCa.
Domain C: Optimising the care pathway
The rapid changes the NHS has made in response to the pandemic has opened opportunities for new models of care in PCa, from remote consultations to delivery of care closer to home (and away from main hospital sites where transmission of COVID-19 may be a concern). These approaches have the potential to minimise any COVID-19 associated risks to the individual and provide an improved patient experience (i.e., less travelling for treatment, shorter wait times etc.) in addition to providing efficiencies for care providers.
The vast majority of HCPs agree that a centralised digitally-based clinical assessment resource should be developed and shared with all acute NHS trusts (93%) and that this should be funded by the NHS (94%). The development and use of such a resource would marry well with the objectives of the Getting It Right First Time (GIRFT) programme in reducing unwanted variation. In addition, a minimum standard set should be agreed for existing systems. NHS Digital has produced a draft framework for digital, data and technology standards. The draft framework contains 10 standards to support commissioners and providers to select and implement this type of resource locally.18
The use of robust recall systems to manage processes such as blood tests and ADT administration is not consistent across the NHS, as shown by the response to statement 18 (67%), and consequently, patients may not be receiving optimal care. Given the development of vaccine rollout and electronic messaging systems in response to COVID-19, there is an opportunity to adopt similar approaches in the management of PCa patients. Examples of enhanced electronic patient record (EPR) systems in use by the NHS include the MY CARE programme implemented in Devon and My Care Record, in use in Hertfordshire.19,20 The steering group identified two prominent features of successful recall systems (including those used in the COVID-19 vaccination programme):
Co-ordination at scale and staff being dedicated to the task in hand. Primary Care Network-level co-ordination of communication and recall systems has supported a highly consistent approach.
These options for accessing and delivering care should be considered and agreed with the individual patient. There is a clear acknowledgment of the increasing role of remote methods for patient contact (97%), however these must be suitable for all age groups including the elderly (83%).
Domain D: Initiation & optimisation of ADT therapy
ADT options are often seen as clinically similar by prescribers, and NICE guidelines generally reflect this by recommending ADT as a class of treatment. The choice of ADT may therefore come down to other factors, including costs, the existence of rebate schemes, local relationships and patient preference. The experience of managing COVID-19 has shone a light on the practicalities of delivering treatment that goes beyond the clinical aspects of a treatment and there was strong agreement amongst responders that these factors are considered when making decisions. It is vital that patients are involved in treatment decisions (98%) as there are factors that influence patient experience, and these should be discussed.21 HCPs agree that needle type/size (79%), injection frequency (95%) and safety profile (99%) are all factors that should be considered, and this is supported by research into patient perspectives of treatment:
- A survey of 165 men with PCa found that 63% (n=104) preferred 6-monthly luteinizing hormone-releasing hormone agonist (LHRHa) injections compared to 3-monthly (22%, n=36), and annually (15%, n=25). In addition, those patients on 6 months of treatment in the adjuvant setting would only require a single injection for the entire duration of therapy.22
- A European study conducted 200 interviews with PCa patients, the results identified six key quality of life factors that patients deem important in their treatment decisions, one of which was ‘hormone injections are required too frequently’.21
|Consider patient factors when selecting ADT options:
Responders agree that there is an opportunity to reduce COVID-19 transmission and reduce capacity demand through the use of treatments with a longer interval between administration (96%). The British Association of Urological Surgeons supports the approach of using longer acting (e.g., 6-monthly) ADT preparations in PCa, stating:8
- For patients in recovery/plateau phase the use of 6-monthly preparations of ADT/LHRH agonists should be expedited
- In patients undergoing treatment for metastatic prostate cancer: commence ADT treatment following bone scan or other imaging if available, ideally 6-monthly preparations should be used.
Clinicians should consider whether monthly preparations may be reserved for intermittent treatment with ADT rather than those with a longer duration of action. This approach was supported by strong agreement that understanding of the use of 3- and 6-monthly treatments should be increased in both primary (96%) and secondary (90%) care.
As with all surveys, potential limitations of this study include the way in which the questions were worded and the order in which they were asked, and how respondents were approached. However, the questions were constructed by the steering group who also ratified the final form of the questionnaire before distribution. There was also a good representation from both primary and secondary care services.
There was a strong response from England (245/277) compared with other regions, meaning that the overall results were therefore heavily influenced by practice in England. That said, the comparison of responses between England and other regions showed similar patterns of agreement with the statements.
This consensus was focused specifically on clinical opinion. Patient experience has not been captured; this input would be important, and even essential when discussing the preference of patients.
The following recommendations are offered based on the learnings identified through the consensus exercise:
a. The use of enhanced Electronic Patient Record systems to manage patient recall
b. Delivery co-ordinated at scale (PCN, Integrated Care System (ICS) or equivalent level) with staff dedicated to this specific task
Steps taken to tackle the COVID-19 pandemic have resulted in a growing backlog of patients requiring PCa services (diagnosis and treatment) and cancer services should consider how they can best manage the backlog whilst maintaining standards of care for existing patients.
The results of the consensus have provided a strong indication of the attitudes of clinicians that supported optimal ADT in PCa. The steering group formed a strong set of recommendations with the aim of delivering optimal care under anticipated pressure arising from the resumption of cancer services.
Strategies implemented during the COVID-19 pandemic could be adopted to help services manage both capacity concerns and patient preference:
- The use of virtual consultation methods to minimise patient risk and improve convenience
- Use of digital solutions to manage patient activity (blood tests, consultations etc.) through the PCa pathway, providing communications to patients regarding appointments and the record of consultations
- Consideration of patient preference and practical aspects of treatment when making decisions around treatments, with the potential to both improve patient experience and reduce capacity demands through the use of longer-acting options.
- The Yorkshire Hospitals NHS Trust
- Attenborough Surgery, Bushey
- General Practitioner, Devon
- Freeman Hospital, Newcastle Upon Tyne NHS Foundation Trust
- St George’s Medical Practice, Darlington
- CCG Programme Director, Medicines Optimisation
- Independent Pharmacist, Sussex
- New Cross Hospital, Wolverhampton
- Triducive Partners Limited, St Albans
- National Institute of Health and Care Excellence (NICE). Prostate cancer: diagnosis and management. May 2019.
- Cancer Research UK. Prostate cancer statistics. Available from https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer [Accessed August 2021]
- Gamat M, McNeel DG. Androgen deprivation and immunotherapy for the treatment of prostate cancer. Endocr Relat Cancer. 2017 Dec;24(12):T297-T310.
- NHS Kent and Medway Cancer Collaborative. The Management of Prostate Cancer: Pathway of Care. September 2016.
- Pan Birmingham NHS Cancer Network. Guidelines for Management of Prostate Cancer. June 2012.
- Macmillan Cancer Support. The Forgotten ‘C’ The impact of Covid-19 on cancer care. October 2020.
- Maringe C, Spicer J, Morris M, et al. The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study Lancet Oncol 2020, 21(8): 1023-1034.
- British Association of Urological Surgeons. COVID-19 strategy for the Interim Management of Prostate Cancer Prepared by the BAUS Section of Oncology. May 2020.
- Obek C, Doganca T, Argun OB, et al. Management of prostate cancer patients during COVID-19 pandemic. Prostate Cancer Prostatic Dis 2010. 23: 398–406.
- Alshamrani M, AlHarbi A, Alkhudair N, et al. Practical strategies to manage cancer patients during the COVID-19 pandemic. J Oncol Pharm Pract. 2020 Sep;26(6):1429-1440
- Dalkey N, Helmer O. An experimental application of the Delphi method to the use of experts. Management sci. 1963, 9:458-467.
- Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, Wales PW. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014 Apr;67(4):401-9.
- NHS Confederation. NHS Reset. Available from https://www.nhsconfed.org/NHSreset [Accessed 12/05/21]
- Donnelly, DW, Gavin, A, Downing, A, et al. Regional variations in quality of survival among men with prostate cancer across the United Kingdom. Eur Urol 2019; 76(2): 228–237.
- National Prostate Cancer Audit. Variation in the treatment of men with high-risk/locally advanced prostate cancer in England. October 2020.
- Orchid. Prostate cancer - Britain’s growing problem. 2018
- NHS. Long Term Plan. 2019.
- NHS Digital. The NHS digital, data and technology standards. Available from: https://digital.nhs.uk/about-nhs-digital/our-work/nhs-digital-data-and-technology-standards/framework#the-nhs-digital-data-and-technology-standards [Accessed August 2021]
- Royal Devon and Exeter NHS Foundation Trust. RD&E Goes Live with ‘Game Changing’ Transformation Programme this Weekend. Available from: https://www.rdehospital.nhs.uk/news/rd-e-goes-live-with-game-changing-transformation-programme-this-weekend/ [Accessed August 2021]
- Herts Valleys CCG. My Care Record. Available from: https://hertsvalleysccg.nhs.uk/about-us/what-we-do/my-care-record [Accessed August 2021]
- Schulman C. Assessing the attitudes to prostate cancer treatment among European male patients. BJU Int. 2007 Jul,100 Suppl 1:6-11.
- Khan A, Davda R, Dumas L, Payne H. Patient survey exploring preferences in frequency of administration of LHRH agonists. Int J Clin Pract. 2012, 66:1–4.
This supplement has been commissioned and funded by Ipsen UK Ltd and developed in partnership with Guidelines in Practice. Ipsen UK Ltd suggested the topic and authors, and carried out full medical approval on all materials to ensure compliance with regulations. The authors were paid honoraria. The views and opinions of the authors are not necessarily those of Guidelines in Practice, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher.
Date of preparation: October 2021