Dr Sadaf Haque Picks out Five Key Learning Points from the updated NICE Prostate Cancer Guideline That Are Relevant to Primary Care
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Prostate cancer is diagnosed in more than 47,000 people in the UK every year,1 with about 1 in 8 men being diagnosed during their life.2 It is the most common cancer diagnosed in males aged 45 years and over, peaking at 32.8% of all cancers in the 65 to 74 years age range.3 It also can affect transgender women.2 Prostate cancer was the second most common cancer in England in 2017 (13.5%), and represented the third most common cause of cancer deaths in the UK in 2016 (7%).4 More than 50% of cases in 2012 were diagnosed in men aged 70 years and over, with the highest incidence in 2012 to 2014 in men aged 90 years and over.2 Based on data for 2014, 40% of cases of prostate cancer were diagnosed at a late stage, which carries a 5-year or more survival rate of only one-third, compared with diagnosis at the earliest stage, when virtually all people with prostate cancer survive for 5 years or more.2 According to NICE, incidence rates in the UK are projected to rise by 12% between 2014 and 2035 to 233 cases per 100,000 in 2035.2
People of African family origin are at higher risk of prostate cancer (lifetime risk of approximately 1 in 4), which is inversely associated with deprivation, with a higher incidence of cases found in more affluent areas of the UK.2
In May 2019, NICE published NICE Guideline (NG) 131 on Prostate cancer: diagnosis and management, which covers:2
- diagnosis and risk-stratification of prostate cancer in secondary care
- management (including adverse effects of treatment) of localised, locally advanced, and metastatic prostate cancer, including hormone-relapsed prostate cancer in secondary care
- follow up in primary care with agreed shared-care protocols.
This article highlights the five areas in NICE NG131 that are most relevant to GPs:
- the complexity of prostate cancer, and its diagnostic and treatment modalities after risk-stratification
- the choice between active surveillance, radical prostatectomy, or radical radiotherapy for people with localised prostate cancer—if a shared-care protocol has been agreed locally, hormone therapy administration and monitoring of prostate-specific antigen (PSA) levels may be carried out in primary care2
- adverse side-effects associated with radical treatment and hormone therapy, which may alter a person’s quality of life, and how these can be minimised
- the importance of communication, information, and decision support for people with prostate cancer, their partners, and carers
- implementation in primary care of shared care and follow up, supported self-management, and palliative care.
Referral and assessment for suspected prostate cancer is covered separately in NG12 on Suspected cancer: recognition and referral5 —see Box 1 for a summary of the relevant recommendations.
Note: some of the treatments discussed in this article do not currently (September 2019) have UK marketing authorisation for the indications mentioned. The prescriber should follow relevant professional guidance, taking full responsibility for all clinical decisions. Informed consent should be obtained and documented. See the General Medical Council’s guidance on Good practice in prescribing and managing medicines and devices6 for further information.
|Box 1: Referral and Assessment for Suspected Prostate Cancer5|
Refer men using a suspected cancer pathway referral (for an appointment within 2 weeks) for prostate cancer if their prostate feels malignant on digital rectal examination
Consider a prostate‑specific antigen (PSA) test and digital rectal examination to assess for prostate cancer in men with:
Refer men using a suspected cancer pathway referral (for an appointment within 2 weeks) for prostate cancer if their PSA levels are above the age‑specific reference range.
© NICE 2019. Suspected cancer: recognition and referral. Available from www.nice.org.uk/ng12 All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this publication. See www.nice.org.uk/re-using-our-content/uk-open-content-licence for further details.
1. Prostate Biopsy Can Sometimes be Omitted
It is important to be aware of the different diagnostic and management options for prostate cancer where shared decision-making may be supported in primary care. Prostate cancer can broadly be divided into three categories:
- localised prostate cancer, including:
- low-risk localised —treatment options are active surveillance, radical radiotherapy, or radical prostatectomy
- intermediate-risk localised —treatment options are radical radiotherapy, radical prostatectomy, or active surveillance if the person wishes to defer radical treatment
- high-risk localised —treatment options are radical radiotherapy and radical prostatectomy (do not offer active surveillance)
- locally advanced prostate cancer
- metastatic prostate cancer.
NICE recommends that people with suspected clinically localised prostate cancer (only those who are suitable for radical treatment) are offered multiparametric MRI (mpMRI) as the first-line investigation.2 Results are reported using a 5-point Likert scale, which improves the diagnostic ability of the mpMRI as it takes into account clinical factors, not just the lesion size. NICE recommends that mpMRI prostate biopsy is offered to those with Likert score of 3 or more.
Primary care healthcare professionals may be able to support the patient with decision-making as to whether or not to have an MRI or prostate biopsy by discussing their PSA level, their digital rectal examination (DRE) findings, any co-morbidities, together with their risk factors (including increasing age and black African-Caribbean family origin), or any history of a previous negative prostate biopsy. Table 1 provides a summary of advantages and disadvantages of subsequent mpMRI-influenced prostate biopsy for those with Likert score of 1 or 2.2
It is also important for people and their partners or carers to understand the risks of an increased chance of having to live with a diagnosis of clinically insignificant prostate cancer (see Table 1).
Table 1: Factors to Consider When Discussing the Options for People Whose Multiparametric MRI Likert Score is 1 or 22
|Advantages of Undergoing Prostate Biopsy||Disadvantages of Undergoing Prostate Biopsy|
You may have prostate cancer that the MRI scan missed:
|There is no guarantee that a prostate biopsy will find any disease that is there. Prostate biopsies find less than half of the clinically significant prostate cancers that MRI scans miss.|
|You may be diagnosed with clinically insignificant prostate cancer. This is disease that is unlikely to be life-threatening, but will need monitoring and may lead to treatment. Therefore, if someone has prostate cancer that truly is clinically insignificant, it is better not to find it. Between 18 and 23 out of 100 people with a low-risk MRI get a diagnosis of clinically insignificant prostate cancer if they have a prostate biopsy.|
|The most common type of biopsy, transrectal ultrasound-guided (TRUS), has some rare but important complications. The most serious is sepsis, which develops in a bit less than 1 out of 100 people. Other serious complications, including acute urinary retention, severe haematuria and severe rectal bleeding may need hospitalisation.|
TRUS biopsy has less serious complications that make it unpleasant to undergo for some people. On average:
There is more than one type of prostate biopsy. The most common approach is TRUS biopsy. The data in this table come from the PROMIS and ProtecT studies, which used TRUS. There are no equivalent data for other types of biopsy.
The ranges given in the figures above reflect different definitions of clinically significant prostate cancer (UCL1 and UCL2; see PROMIS publications).
2. Active Surveillance is an Alternative to Radical Treatment
Previously, active surveillance was often offered as a non-preferred treatment rather than as an equal choice alongside prostatectomy and radiotherapy. Many people with low-risk cancer live for many years with no disease progression, so the NG131 guideline committee agreed that active surveillance was a safe option for people with low-risk localised prostate cancer. Many people may also prefer active surveillance considering the lasting negative effects of radiotherapy or prostatectomy. NG131 also recommends that active surveillance might be a safe option for some people with intermediate-risk localised prostate cancer, although for this group there is a greater risk that the cancer will have an impact on their lives and they are more likely to need radical treatment. NG131 recommends that active surveillance is not offered to people with high-risk localised prostate cancer—these recommendations remain unchanged as there is no new evidence to suggest active surveillance is beneficial in this group.2 This new recommendation (regarding active surveillance for men with low-risk localised or intermediate-risk localised cancer) could affect almost 8000 of the 47,000 men diagnosed annually with the disease, by avoiding or delaying treatment, which can have adverse effects.2
Although radiotherapy and surgery are both shown to reduce the likelihood of disease progression and development of distant metastases, NICE examined trial evidence that showed there was no 10-year survival difference between radical prostatectomy, radical radiotherapy, or active surveillance.2 To help clinicians and patients to decide which option is most appropriate for the individual’s circumstances, NG131 includes a table of factors to consider when discussing active surveillance, radical prostatectomy, or radical radiotherapy as treatment options for people with low-risk or intermediate-risk localised prostate cancer.2
In its recent consensus statement on best practice in active surveillance, Prostate Cancer UK identified the importance of emotional and psychological support for those diagnosed with the disease, particularly when discussing active surveillance at the outset and over the first 2 years of treatment.7 The lead author commented: ‘Despite the potential benefits for men, choosing active surveillance over radical treatment is not necessarily an easy decision as it goes against the natural instinct of wanting to get rid of the cancer immediately.’8
There are key differences between policies of active surveillance and watchful waiting, and these are compared in Box 2.
|Box 2: Active Surveillance vs Watchful Waiting in Localised Prostate Cancer|
Active surveillance is part of a ‘curative’ strategy and is aimed at people with localised prostate cancer for whom radical treatments are suitable, keeping them within a ‘window of curability’ whereby only those whose tumours are showing signs of progressing, or those with a preference for intervention, are considered for radical treatment. Active surveillance may thus avoid or delay the need for radiotherapy or surgery.2 Offer mpMRI to people having active surveillance who have not had an MRI previously.2
3. Offer Support for Adverse Effects of Treatments
It is helpful for primary care to be aware of the types of adverse effects associated with radical treatment and hormone therapy including with:2
- radical prostatectomy, including robotic surgery for localised prostate cancer
- radical external beam radiotherapy
- pelvic radiotherapy
- androgen-deprivation therapy
- docetaxel chemotherapy.
NICE NG1312 makes recommendations on support and therapy for adverse effects of these treatments. The recommendations detailed in Box 3 may be relevant to primary care, especially under shared-care agreements.
|Box 3: Recommendations from NICE Guideline 131 on Support and Therapy for Adverse Effects of Prostate Cancer Treatments that are Relevant to Primary Care|
Hot flushes (androgen deprivation)
Sexual dysfunction (androgen deprivation and radical treatment)
Urinary incontinence (radical treatment)
Radiation-induced enteropathy (radical treatment)
Readers are advised to refer to NICE Guideline 131 for all recommendations about support and therapy for adverse effects of prostate cancer treatments.
4. Provide Information and Decision Support
Prostate cancer is a complex disease process with several management options which require consideration by the person and, if they wish, their partner or carer.
NG131 is clear as to the role of a urologist or specialist nurse in advising about potential longer-term adverse effects of treatment and when and how to report them, together with the purpose, duration, frequency, and location of follow up.2
Some people, their partners, and carers, may want to return to see their GP to discuss their concerns and options. It is helpful for GPs to be aware of and able to signpost sources of further information (for example, Macmillan Cancer Support, Prostate Cancer UK, Cancer Research UK, Men’s Health Forum, and local prostate cancer support groups), as well as referring back to the urology teams, including Clinical Nurse Specialists.
If a patient with low-risk prostate cancer has been able to make an informed decision and opted for active surveillance, NG131 recommends ensuring there is an agreed shared-care protocol with primary care to carry out PSA testing (patient-centred care), but acknowledges that the expertise of carrying out a digital rectal examination lies with secondary care healthcare professionals.2
5. Collaborate to Provide Effective Shared Care
Shared-care protocols should clearly define where clinical and prescribing responsibility lies between secondary and primary care, as well as monitoring requirements and actions to be taken on abnormal results.
Primary care can provide follow up:2
- after at least 6 months’ initial follow up in secondary care, for people with a stable PSA who have had no significant treatment complications, unless they are taking part in a clinical trial that needs formal clinic-based follow up
- for people with prostate cancer who have chosen a watchful waiting regimen with no curative intent, if protocols for this have been agreed between the local urological cancer MDT and the relevant primary care organisation(s).
NG131 also includes further detail about when to consider a remote follow-up strategy based on PSA levels. Primary care should not need to calculate thresholds for re-referral as it should be done by specialist healthcare professionals and provided when discharging the patient.2
Treatment summaries are completed by secondary care professionals (usually the MDT) after a significant phase of a patient’s cancer treatment.11 They should be provided as part of the recovery package for personalised care, and are designed to be shared with the person living with cancer and their GP. This means that both primary care and the patient will be better informed about follow-up protocols, side-effects of treatment, potential longer-term consequences of treatment, red flag signs and symptoms, and re-entry pathways into secondary care.
People with metastatic prostate cancer should be offered a regular review of their needs, and personal preferences for palliative care should be discussed early, including partners and carers in the discussions if appropriate. Treatment and care should be tailored to the person’s wishes and the preferred place of care, which should not be restricted to hospice care, should be identified.2 Palliative care should not be limited to end of life, but should be available when needed.
The recently updated NG131 on Prostate cancer: diagnosis and management supports previous guidance on using a person-centred approach2 and informed decision-making, which may involve a primary-care consultation if the patient chooses. NG131 recognises the important role of primary care in agreed resourced shared-care protocols for remote monitoring as well as palliative care.
Dr Sadaf Haque
GP & Clinical Lead for Cancer, One Gloucestershire ICS (Macmillan GP Facilitator)
Somerset, Wiltshire, Avon & Gloucestershire (SWAG) Cancer Alliance Early Diagnosis & Prevention Lead (CRUK GP)
Member of the guideline development group for NG131
SH has no competing interests relating to this NICE guideline (NG131).
The author would like to acknowledge all of the members of the 2019 Prostate cancer: diagnosis and management (update) guideline development group.