PSA Testing for men aged 80 years and above
Best Practice Guidance
How up to date is this information?
Published January 2024 | No further review planned
Using this guidance
The guidance set out here was reviewed extensively in the Autumn of 2024. There are no plans for any further reviews.
Medicine is constantly evolving and over time it is inevitable that the evidence base will change. Please use your own judgement and/or other sources of clinical guidance alongside the information set out here.
Please note this guidance is a recommendation and it should be used in the context of the overall care pathway and when all alternative interventions that may be available locally have been undertaken.
Summary
These recommendations aim to maximise shared decision making between men who are 80 years old or older and primary care clinicians in relation to the investigation and diagnosis of prostate cancer. By developing a clear understanding of the potential outcomes to PSA testing for this group it will begin to address the harm associated with overdiagnosis and overtreatment and the wide variance in care delivery across the country. It provides clarity and guidance to primary care providers on when it is appropriate to refer a concerned patient aged over 80 to a secondary specialist care following a PSA test.
This guidance relates to those who have a prostate, this includes:
- Cismen (men who identify as male and were assigned male at birth)
- Trans women (women who identify as female and were assigned male at birth)
- Non-binary people who were assigned male at birth
- Some intersex people.
The information has been developed based on guidance and evidence in men. If you are a trans woman,
male-assigned non-binary or intersex, some of this information is still relevant to you — but your
experience may be slightly different.
Please note for the purposes of this recommendation and to align with the evidence when we use ‘men’ it refers
to all those with a prostate.
Prostate cancer is common, up to 1 in 8 men are diagnosed during their lifetime with over 45,000 cases diagnosed each year in England and Wales. It is a common cause of cancer-related death globally. In the UK, prostate cancer diagnosis typically begins in primary care with a blood test for serum prostate specific antigen (PSA) and/or a digital rectal examination. A PSA test may be performed in asymptomatic patients concerned about the risk of prostate cancer or in individuals with symptoms localised to the urinary tract or indicative of metastatic disease, who are defined as ‘symptomatic’ in national guidance. The PSA level that should prompt specialist referral is defined at a fixed threshold for asymptomatic men and at age-specific thresholds for ‘symptomatic’ men. An age-specific PSA threshold is not defined for men aged over 80 in NICE guideline NG12 due to the lack of evidence in this group; instead ‘clinical judgement’ is advised. In the absence of specified value for this age-group, individual cancer alliances have devised their own numerical thresholds with significant regional variation. Screening and monitoring PSA levels in men over 80 can create health anxieties and unnecessary hospital visits. Simple numerical cut-offs can miss the bigger picture, including what a referral for suspected prostate cancer is likely to involve, and what factors are important in treatment decisions.
PSA testing of men over 80 is often offered to men with lower urinary tract symptoms (LUTS) in line with national guidance, although LUTS are not a reliable indicator of localised prostate cancer and are common in this age-group due to other causes. In fact, prostate cancer confined to the prostate gland often does not have any symptoms. Many of these men could be considered ‘asymptomatic’ with the PSA test therefore constituting a form of screening. PSA testing is known to have a poor specificity in this age-group, meaning many with a raised test will not have cancer. This can result in over-investigation, including prostate biopsy, which carries significant risk. The need for a biopsy has partly been mitigated by the introduction of multi-parametric prostate magnetic resonance imaging (MRI), but this is resource intensive.
Evidence shows there is a particular risk of over-diagnosing prostate cancer and overtreating prostate cancer in men over 80 where the prevalence of cancer is highest, but the proportion of cancers which are clinically significant is lowest. For many patients although they may have cancer, it will not cause symptoms in their lifetime or impact their life expectancy. Tests and treatments may in fact expose the patient to additional risks and unnecessary anxiety. Studies have shown that men aged between 50-70 years old are most likely to benefit from PSA testing. Individuals would need to have a further life expectancy of at least 10 years to benefit from radical treatment for localised prostate cancer. This will not be true for many, with the median life expectancy at only 8 years for a man turning 80 in the UK. The diagnosis and radical treatment of prostate cancer carries a significant risk of side effects that can negatively impact quality of life and it is important that these are avoided where treatment will not improve quality of life or survival. Active surveillance can be a safe and effective for managing patients with prostate cancer and localised disease, giving more time for men to make decisions on radical treatment. Clinicians and patients are both poor predictors of life expectancy, meaning that some patients with slow growing cancers but a high level of comorbidity are ‘overtreated’.
PSA testing is a highly complex and contentious area, and it is important that primary care clinicians and patients are appropriately supported to allow shared decision making together.
This guideline aims to complement NICE guideline NG12 by providing detail on the principles that should inform a shared decision making process in men over 80 who are considering, or who have had, a PSA test.
These recommendations aim to ensure:
- Localised prostate cancer is diagnosed in all individuals who would benefit from radical treatment.
- Over-diagnosis and overtreatment are minimised in those who don’t have cancer or have clinically insignificant prostate cancer where radical treatment is unlikely to be of benefit and could cause harm.
- Men with metastatic prostate cancer are identified and offered treatment where appropriate.
- Improving the quality of life for men over 80 with slow growing prostate cancer.
- Support shared decision making between primary care clinicians and patients in relation to PSA testing.
Recommendation
Scope
This guideline aims to support primary care clinical decision making in men aged over 80 where PSA testing is being considered or where a PSA test has been performed.
NICE guideline NG12 advises that primary care clinicians should use ‘clinical judgement’ when deciding whether to refer ‘symptomatic’ men over 80 who have an elevated PSA test.
Recommendations
PSA testing: Framework for shared decision making prior to testing
1. Before a PSA test is performed a shared decision-making process should take place between the patient and the primary care clinician where the limitations of the test and the possible consequences of an abnormal result are discussed. The clinician should consider discussing the following points:
About the PSA test
1.1. PSA can commonly be raised in the absence of prostate cancer (false positive) and ocasionally be normal where cancer is present (false negative).
About localised prostate cancer
1.2. Prostate cancer confined to the prostate gland is typically asymptomatic — Lower urinary tract symptoms (LUTS) are not a reliable symptom of localised prostate cancer for men over 80 years old.
1.3. Prostate cancer confined to the prostate gland is common, but many cancers diagnosed in this age-group will be clinically insignificant meaning they won’t cause symptoms in an individual’s lifetime or shorten their life expectancy.
1.4. An individual must live for at least 10 years to benefit from radical treatment of prostate cancer when it is confined to the prostate gland. However, radical treatment can be associated with side effects (e.g. incontinence and erectile
dysfunction) that impact quality of life.
About metastatic prostate cancer
1.5. When prostate cancer has spread outside the prostate gland there are effective treatments that may help reduce symptoms (but not cure the disease).
PSA testing: Clinical recommendations on testing
1.6. In men over 80, PSA testing should be encouraged where there are symptoms suggestive of metastatic prostate cancer (such as bone pain, unintended weight loss and fatigue).
1.7. In men over 80 without signs of metastatic disease the benefit of PSA testing is uncertain. A PSA test should only be performed in men who want one after an appropriate shared decision-making process (see above). The potential benefits are greater in those with a life expectancy of more than 10 years.
PSA testing: Interpreting test results
1.8. For men ≥80 years of age who have had a PSA test, offer referral via a suspected cancer pathway if:
— the PSA >20 ng/mL;
OR
— the PSA >7.5 ng/mL AND there are symptoms suggestive of metastatic disease (bone pain and/or fatigue and/or significant unintended weight loss).
1.9. If the initial PSA test is between 7.5 – 20 ng/L and there are no symptoms suggestive of etastatic disease, repeat PSA ONCE after 6 months in primary care, prior to any secondary care referral.
1.10. When the PSA is repeated, offer referral via the suspected cancer pathway if:
— either criteria in recommendation 1.8 being met;
OR
— PSA has increased significantly (more than doubled), and the patient has a
performance status of 0 or 1.
1.11. If patients do not fit the above criteria but concerns remain, seek appropriate support via ‘advice and guidance’.
Rationale for recommendation
The panel discussed current NICE guidance on PSA testing in ‘symptomatic’ men and the lack of evidence on the predictive accuracy of age-specific thresholds in this group was acknowledged. The panel considered there was a lack of guidance to support primary care clinicians with ‘clinical judgements’ on PSA testing and on actioning abnormal results. Panel members underlined how individual cancer alliances have introduced local age-specific thresholds to help address this uncertainty but that this has led to significant regional variation in referral patterns. The panel agreed there was a need for unified recommendations covering men in this age group and these would benefit from considering the evidence on prostate cancer treatment, and outcomes rather than simply focussing on the predictive accuracy of the PSA test in isolation. The panel’s opinion that a more holistic view would help mitigate some of the risks associated with over-investigation and overtreatment and have important resource implications.
The panel noted that prostate cancer is a common diagnosis in older men. More than 75% of all prostate cancers are diagnosed in men aged over 65 and it is estimated that approximately 50% of men over 50 years have histological evidence of prostate cancer, rising to almost 80% in men aged over 80. The panel noted that for most men, prostate cancer is slow growing and does not cause symptoms during an individual’s lifetime and/or affect life expectancy. The panel noted that there is a particular risk of over-diagnosing and overtreating prostate cancer in men over 80 where the prevalence of cancer is highest, but the proportion of cancers that are clinically significant is lowest.
The role of PSA testing in over-diagnosis was discussed. The panel noted that PSA testing can advance the time of diagnosis, but this may not confer treatment benefits where cancers are indolent, or life expectancy is limited. It was noted that the longterm prognosis for older men with PSA-detected prostate cancer is excellent, including those treated conservatively. Studies looking at prostate cancer-specific mortality after radical treatment of localised disease were reviewed, and the panel agreed that those with a life expectancy less than 10 years are unlikely to derive benefit from radical treatment. The difficulties with predicting life expectancy were noted. Evidence was presented that patients and clinicians do this poorly and that clinicians often fail to appropriately adjust for comorbidities, leading to a tendency to overestimate survival. The panel concluded that early diagnosis, in certain cases, may expose patients to harm through treatments that do not benefit quality of life or survival.
The panel discussed the utility of the World Health Organization (WHO) performance scale — which is simple, widely used, and has good inter-rater reliability — in helping identify those who might benefit from early diagnosis and treatment. The panel considered that only individuals with a performance status under 2 should be offered radical treatment of localised prostate cancer given how long the benefits of treatment take to be realised. It was therefore agreed that performance status would be used as one criterion for screening patients for onwards referral. It was the view of the panel that patients would need to be provided with clear information on the rationale behind the decision-making process and that ‘advice and guidance’ should be used by primary care where there was clinician or patient uncertainty.
The panel acknowledged that the benefit of radical treatment in men over 80 with the highest performance status will be equivocal and relate, among other things, to the precise histological features of an individual’s cancer. These individuals stand to benefit from a histological diagnosis, which can then be used as part of risk prediction algorithms such as Predict Prostate to individualise treatment decisions. The panel noted that even among this group, only approximately 10% of patients receive radical treatment (predominantly radiotherapy) (National Cancer Registration and Analysis Service 2013-2019). A consensus expert view was taken that the PSA cut-off for the lower 70-79 age group should be used as a threshold for PSA monitoring in primary care, and that men should be referred where their PSA is rapidly rising.
There was considerable discussion on the value of LUTS as a symptom of prostate cancer and it was noted that LUTS continue to form an important part of national guidelines and media health campaigns. Evidence evaluating the diagnostic utility of LUTS was reviewed and the negative association between LUTS and localised prostate cancer diagnosis in screening studies was noted. The findings of a 2013 Cochrane review, which concluded that ‘the presence of LUTS, typically due to benign prostatic obstruction, are very common in the ageing male and are not considered to increase prostate cancer risk’, were felt to be significant. PSA for LUTS was noted to be an important factor contributing to overinvestigation and overdiagnosis and the panel agreed that this issue should be addressed explicitly in the guidance.
The panel considered the benefits of early hormonal treatment for localised disease in those not fit enough for radical treatment. It was noted that the current evidence only supports early hormonal treatment in those with a baseline PSA > 50 ng/ml and/or a PSA doubling time < 12 months. An age-specific PSA threshold of 20 and repeating PSA measurement in those with a PSA>7.5 at six months (to pick up individuals where PSA is rapidly rising), was considered adequate to ensure all individuals potentially benefitting from early hormonal treatment were seen in secondary care.
The panel agreed on the importance of ensuring all men with suspected metastatic disease are offered referral to secondary care. The panel came to a consensus on the typical symptoms of metastatic disease (bone pain, fatigue, and unintended weight loss) and agreed that even a mildly raised PSA in these individuals should prompt a high index of suspicion of metastatic cancer. A PSA above the age-specific threshold for the 70-79 age group was agreed upon as a reasonable referral threshold where possible symptoms of metastatic disease exist. The appropriate PSA threshold for detecting metastatic disease in asymptomatic patients was also considered. The available evidence indicates that a PSA threshold of 20ng/ml has a high sensitivity for detecting asymptomatic metastatic disease.
Patient information
What is a PSA test?
The prostate, which is a gland about the size of a ping pong ball located just below your bladder, produces the protein PSA. If the levels of PSA in your blood are raised it can be an indicator of cancer.
The Prostate-specific antigen (PSA) test is a blood test used to help detect prostate cancer. It is normally carried out by your GP or clinician at your local surgery. Your blood sample will be sent to a laboratory to measure its PSA level.
When should a PSA test be carried out?
A PSA test should be performed on a case-by-case basis, when finding and treating early prostate cancer would help improve a person’s life expectancy or quality of life.
It is entirely normal for you to have a small amount of PSA in your blood. However, you may have raised PSA levels for other reasons including diet, sexual activity, vigorous exercise, recent infection, or if you are taking some medications. The amount of PSA tends to increase as you age because the prostate gets bigger over time — a larger prostate releases more protein.
A raised PSA might also be due changes in your urine flow, known as lower urinary tract symptoms (LUTS). For example, you may find it difficult to begin to pee, or your flow may stop and start when you are peeing. You may need to take a pee more urgently or during the night. As men age, they can experience LUTS due to age-related enlargements in the prostate. Generally, LUTS are not a sign of prostate cancer, and should not automatically mean you need a PSA test.
Should everyone be tested?
The test itself may not be suitable for everybody. For men over 80, before having a PSA test we recommend talking with your doctor about what the test involves and the implications for you. This will help you decide together, what is best for you. If you choose to have the test, this guidance can also help decide if a referral to a specialist doctor such as a urologist is likely to be beneficial.
Coding
There is currently no coding for this intervention
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