Professor David Weller explains how primary care can implement the NICE guideline on prostate cancer through diagnosis, follow up, monitoring, and provision of information
  • Prostate cancer diagnosis requires thorough history and examination; GPs should undertake a DRE, assess risk factors (including increasing age, black African and black Caribbean ethnicity), and any previous relevant history (such as a negative biopsy)
  • PSA testing is more controversial; recent results from randomised control trials have not provided clear guidance. However, primary care has a key role in providing information about PSA testing
  • The PSA test result should not be used in isolation in deciding whether to proceed to further investigations. Multiple clinical factors, such as PSA, DRE, age, race, prostate volume, family history, and previous negative biopsy, can be used to improve the sensitivity of diagnosis
  • Psychosexual aspects of prostate cancer are frequently neglected; GPs have a key role in addressing psychosocial concerns as well as erectile dysfunction and other sexual issues
  • Men with low-risk, localised prostate cancer (which might be considered suitable for radical treatment) should first be offered ‘active surveillance’, while ‘watchful waiting’ is an option for men whose disease has advanced; both these approaches require important information provision and support roles from primary care
  • The NICE guideline recommends that after 2 years, follow up should be performed outside secondary care settings if the patient has a stable PSA level and no treatment complications. This has significant implications for primary care, requiring organised systems of PSA testing, symptom monitoring, and psychosocial support
  • There is a great deal of interest in developing new models of prostate cancer follow up in which care is better coordinated between primary and secondary care services
  • Primary care has a key role in monitoring treatment side-effects both from radical treatments such as prostatectomy and radiotherapy, and from later-stage treatments such as hormone therapy
  • A wide range of treatments are available for advanced disease, including bilateral orchidectomy, continuous LHRHa therapy, and anti-androgen monotherapy. In hormone-refractory prostate cancer, docetaxel and corticosteroids are treatment options

DRE=digital rectal examination; PSA=prostate specific antigen; LHRHa=luteinising hormone-releasing hormone agonist


Prostate cancer is very common in the UK—it represents nearly a quarter (24%) of all new male cancer diagnoses, and each year over 36,000 new cases are identified. The lifetime risk of prostate cancer for men in the UK is 1 in 10.1

There has been a highly significant rise in prostate cancer incidence over the past 20 years, although there has not been a corresponding increase in mortality rate. Table 1 shows the numbers and rates of new cases in the UK and its constituent countries.2–5 Much of the increase in incidence is as a result of the use of prostate specific antigen (PSA) testing—rates of testing have risen considerably over the last decade in England and Wales.6

The NICE guideline on Prostate cancer: diagnosis and treatment was published in 2008.7 While it is, perhaps understandably, quite focused on hospital-based approaches to management, it includes some important information for primary care, particularly in the area of follow up. From an international perspective, there are many guidelines for prostate cancer, and they vary considerably in content and quality.8 This reflects, in part, the lack of definitive evidence to support key areas of diagnosis and management. The NICE guideline is based on systematic review of available evidence, and uses rigorous methods in formulating its recommendations.7

Table 1: Number of new cases and rates of prostate cancer, UK 20071
  England Wales Scotland N. Ireland UK
Cases 30,201 2478 2507 915 36,101
Crude rate per 100,000 population 120.3 170.4 100.9 106.1 120.7
Age-standardised rate (European) per 100,000 population 97.2
(CI 99.8–102.0)
123.1
(CI 104.6–123)
80.7
(CI 82.8–89.4)
101.0
(CI 88.1–100.9)
97.3
(CI 98.9–101.0)
Reprinted from Cancer Research UK. Prostate cancer—UK incidence statistics. info.cancerresearchuk.org/cancerstats/types/prostate/incidence/index.htm (accessed 7 July 2010). Reproduced with kind permission from Cancer Research UK.

Diagnosis

The NICE guideline emphasises the diagnostic dilemmas posed by prostate cancer, and these are particularly pertinent in primary care. The symptoms of prostate cancer become increasingly common with advancing age; the incidence and prevalence of prostate cancer also increase with age and it is often emphasised that men are much more likely to die ‘with’ prostate cancer than ‘of’ it. Hence, making a diagnosis of prostate cancer may not improve patient outcomes, and may actually cause harm from adverse effects of investigations and treatments.9

The guideline recommends that as a routine part of work up, GPs should undertake a digital rectal examination (DRE), assess risk factors (including increasing age, and black African and black Caribbean ethnicity), and review any previous relevant history (such as a negative biopsy).7

Prostate specific antigen testing

Although a careful history and examination are important, a key decision in both symptomatic and asymptomatic patients is whether or not to perform a PSA test. Much of the demand for PSA testing is moderated in primary care—while testing rates in the UK are below those of many other developed countries,1 there is a growing demand for the test, typically in the form of a patient-initiated request to a GP.

Testing for PSA detects many cancers that are not destined to progress (i.e, they remain localised and do not have any significant impact on either morbidity or mortality). The challenge is to try and identify the cancers that are destined to cause harm; while progress is being made in this area, at present it is not possible to predict with any degree of accuracy those cancers that need aggressive treatment (such as radiotherapy or radical prostatectomy) and for which a more conservative approach is warranted. Identifying cancers with the potential for progression is important if PSA testing is to be more effective.10

Recent results from randomised control trials in Europe and North America have not resolved these dilemmas.11,12 The European trial suggests that mortality reductions are possible but that this may be at too significant a cost: too many men may need to be treated unnecessarily and undergo the other consequences of investigations and treatment to make screening justified.11 The US trial was not able to demonstrate any difference in mortality, likely reflecting the high baseline levels of PSA testing in the US population and the difficulty of assembling a true ‘control’ group.12

Primary care
Primary care has a key role in providing information about PSA testing. Web-based decision aids can also have an effect on knowledge, attitude, and behaviour and help improve informed decision making in PSA testing.13 The Prostate cancer risk management programme promotes the concept of informed choice in decisions over prostate cancer screening.14 The NICE guideline avoids the controversy of PSA screening in the general population, but emphasises that the PSA test can play an important role in the diagnostic work-up of patients suspected to have prostate cancer.7 Most importantly for primary care, if a PSA test is performed, patients need a full explanation of the potential and limitations of the test.7

Management

There is evidence that prostate cancer patients are more likely to have a worse experience of care, including after care, than those with other cancers.15 The reasons for this are unclear, but they are likely to relate to the relatively undeveloped state of prostate cancer services (compared with, for example, breast cancer services), and a lack of awareness of available services among patients with prostate cancer. It is important that this imbalance is redressed.

Establishing risk of progression of disease
In any patient newly diagnosed with prostate cancer, it is vital that an assessment of the likely aggressiveness of the disease (that is, the likelihood it will progress and cause harm) is made. The NICE guideline emphasises the importance of this ‘risk stratification’ process.7 This is a focus of a great deal of current research—we presently lack mechanisms to identify the cancers that should be treated aggressively. At present, the process is still based largely on the PSA result, Gleeson score, and clinical stage. A guide to stratifying men according to their level of risk is shown in Table 2.7 The guideline recommends that PSA levels should not be used alone in diagnostic decisions:7 serum PSA level on its own should not be automatically linked to a prostate biopsy as a prelude to further treatment.

The use of nomograms to assist in the decision-making process is emphasised in the NICE guideline.7 By incorporating multiple clinical factors, such as PSA, DRE, age, race, prostate volume, family history, and previous negative biopsy, risk calculators can improve the sensitivity of diagnosis over using a PSA value cut off alone.16 The main emphasis in the guideline is to avoid proceeding automatically to biopsy based solely on the serum PSA level—this carries with it an important role for provision of information by primary care.7

Locally advanced and metastatic disease
There are often complex decisions over the relative roles of hormonal therapy, radiotherapy, and radical prostatectomy. Ideally GPs should be involved in these decisions, particularly where long-term hormone treatments are to be administered and monitored through primary care. These are complex decisions, which require good communication between primary and secondary care. Treatment options for:7

  • locally advanced prostate cancer include neoadjuvant and concurrent luteinising hormone-releasing hormone agonist (LHRHa)
  • metastatic prostate cancer include bilateral orchidectomy, continuous LHRHa therapy, and anti-androgen monotherapy (bicultamide)
  • hormone-refractory prostate cancer include docetaxel and corticosteroids.
Table 2: Risk stratification for men with localised prostate cancer7
PSA
Gleason score
Clinical stage
Low risk
<10 ng/ml
and
?6
and
T1–T2a
Intermediate risk
10–20 ng/ml
or
7
or
T2b–T2c
High risk
>20 ng/ml
or
8–10
or
T3–T4
PSA=prostate specific antigen
National Institute for Health and Care Excellence (NICE) (2008) CG58. Prostate cancer: diagnosis and treatment. London: NICE. Reproduced with permission. Available from www.nice.org.uk/guidance/CG58

 

Monitoring treatment side-effects

General practitioners also have an important role in providing information on the potential side-effects of prostate cancer treatments. These include altered physical appearance, potential sexual dysfunction including ejaculatory problems and loss of fertility, and potential problems with urinary incontinence. The NICE guideline suggests a proactive approach in early identification of concerns particularly around physical appearance and sexual function, with early access to erectile dysfunction, continence, and specialist psychosexual services.

Evidence suggests that each prostate cancer treatment is associated with a distinct pattern of change in quality-of-life domains relating to urinary, sexual, bowel, and hormonal function; these changes influence satisfaction with treatment outcomes among patients and their spouses or partners.17 It is important that primary care teams are aware of the impact on quality of life and the potential strategies to address them.

Active surveillance and watchful waiting

The guideline recommends that men with low-risk, localised prostate cancer (which might be considered suitable for radical treatment) should first be offered ‘active surveillance’ whereby radical treatment might be offered for localised disease but is deferred until there is demonstrable progression of the cancer.7 While active surveillance would normally be led from specialist clinics, there are, again, important roles for primary care through support and providing information throughout this process.

Active surveillance is sometimes confused with ‘watchful waiting’—this refers to a situation in which the disease is recognised to have progressed, and radical treatment is not considered suitable and in which treatments such as hormone therapy are deferred until warranted by evidence of progression. There is no expectation of ‘curative’ treatment in watchful waiting; standard practice would involve periodic PSA testing and rectal examination, with regular monitoring of any new symptoms. Treatment options aim to control the cancer and improve symptoms.

Follow up

A recent systematic review of guidelines on the follow up of patients with prostate cancer (which included the NICE guideline) identified wide variation in practice.8 The NICE guideline recommends that after 2 years, follow up should be undertaken outside secondary care settings if the PSA level is stable and there are no treatment complications, provided that the man has access to the urological cancer multidisciplinary team.7 This has significant implications for primary care; at present few practices have organised systems of routine PSA testing (annual testing is still recommended after the first 2 years) and there is a very wide variety of arrangements around the UK for sharing responsibility between primary and secondary care (e.g. gaining re-access to specialised services, brokering the relationship between urological outreach services and primary care).

There is growing interest in developing models of primary-care-based follow up that adequately address the need for routine monitoring of quality control and the important ongoing psychosocial and psychosexual issues associated with prostate cancer. Various alternative models of care for cancer follow up have emerged, including nurse specialist and primary-care-led follow up, and ‘shared-care’ approaches. Only specialist nurse-led follow up for patients with prostate cancer has been evaluated in randomised trials, which found it to be a safe alternative to consultant-led follow up.18

Patient-centred care

The NICE guideline underlines the need for patient-centred care and emphasises the importance of involving family members and caregivers in decisions and tailoring treatments to men’s needs. Provision of emotional and psychological support for partners is vital.19 Key priorities for implementation include addressing psychosocial concerns as well as erectile dysfunction and other sexual issues.7 There is a considerable emphasis on pointing men in the direction of existing information resources—web-based examples include the Prostate Cancer Charity and Prostate UK.20,21

There is evidence that the psychosocial aspects of prostate cancer are frequently neglected yet there are limited data to support any particular single model of psychosocial care for men with this disease. In the UK, there is evidence of unmet need particularly for services addressing psychological and sexual issues, and primary care is frequently identified as an important provider of such services.22

Conclusion

The incidence of prostate cancer will continue to rise in the UK despite falling mortality rates. Increasingly the potential for management in primary care is being recognised, particularly for long-term follow up of patients with prostate cancer. If we are to rise to this challenge it is important that we develop the necessary systems and models of care to ensure reliable and high-quality monitoring of this disease (including PSA monitoring) and comprehensive systems of addressing psychosocial and psychosexual issues. Increasingly, primary care is taking a role in tailoring hormonal and other treatments in order to provide the best combination of symptom management and quality of life for patients with advanced prostate cancer.

  • Despite prostate cancer being a very common cancer in men, there is no consistent evidence to support a national screening programme
  • Commissioners should consider local educational programmes to ensure GPs and their staff fully counsel patients before performing a PSA test
  • Local referral pathways and guidelines built on the NICE guideline could help in the management of men who are suspected to have prostate cancer following a DRE or who have a single raised PSA result
  • Primary care could be more involved in follow up of patients with prostate cancer for active surveillance, watchful waiting, or hormonal treatment, thereby reducing outpatient tariff charges
  • Commissioners should define this carefully with local specialists in shared care guidelines and possibly as a local enhanced service with GPs, with suitable audit and quality control
  • Tariff prices:a
    • urology outpatients = £194 (first), £96 (follow up)

PSA=prostate specific antigen; DRE=digital rectal examination
awww.dh.gov.uk/paymentbyresults/

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  4. Information Services Division Scotland. ISD Cancer Information Programme. (accessed 25 June 2010).
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