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Interim position on the PSA blood test in asymptomatic men

November 2022

Interim position

Following a review of new evidence and two co-production workshops including men with lived experience, academics, and clinicians, we have agreed some key changes in what we think and say about the PSA blood test for men without symptoms. This is an interim position because a large-scale epidemiological study of PSA blood test use in the UK and an evidence review are currently underway; our position will continue to evolve in response to our findings.

Statement 1

Since the 2019 NICE guidance updatei, the prostate cancer diagnosis and treatment pathway changed to make it safer and more accurate.

Statement 2

The PSA blood test is the first step in the prostate cancer diagnostic pathway. It is a cheap, safe and effective way of identifying men who would benefit from further testing – in the first instance an MRI scan.

Statement 3

There isn’t a national screening programme for prostate cancerxii, so men won’t get invited to have a test. Men at risk, have a right to a PSA blood test for free from their GP if they want onexiv.

Statement 4

The risks from over-diagnosis and over-treatment of prostate cancer have reduced to a point where we believe GPs should proactively engage higher-risk men, about the PSA blood test.

Statement 5

The individual benefits of a PSA blood test will be different for each man. This is because some men will have more risk factors than others or will have pre-existing health conditions. Information or counselling on the PSA blood test should explain this.

Statement 6

Our role, alongside the NHS, is to reach and activate higher-risk men and support them to make an informed choice about whether to have a PSA blood test. We can achieve this through partnership awareness campaigns and our risk checker.

Statement 7

Because Black men have double the risk of prostate cancer and develop it younger, we strongly recommend they talk to their GP about a regular PSA blood test from the age of 45. As a Black man, if you are worried about prostate cancer, you can speak to a GP from any age.

Statement 8

Men with a known family history of prostate, breast, or ovarian cancer – in particular if a first degree relative has died of these cancers – are at higher risk and we strongly recommend they talk to their GP about a regular PSA blood test from the age of 45.

Black Men with a known family history of prostate, breast, or ovarian cancer – in particular if a first degree relative has died of these cancers – are at the highest risk and should seriously consider PSA blood testing at an earlier age.

Statement 9

One normal PSA result can’t rule out a future diagnosis of prostate cancer. Regular PSA tests can spot trends in PSA levels.

Statement 10

The European Commission is calling for prostate cancer screening in men up to 70 on the basis of PSA testing, and magnetic resonance imaging (MRI) scanning as follow-upxxxiii,xxxiv, The recommendations are backed by a combination of evidence from randomised controlled trials and real-world studiesxxxv. We believe this provides good evidence to change current practice but acknowledge that some evidence gaps remain.

Should this recommendation be ratified in Europe, we would urgently call on the UK National Screening Committee to review this evidence in a UK-specific context and assess whether the proposed framework for screening should also be rolled out in the UK.

Which men are at risk of prostate cancer?

There are three main, unmodifiable risk factors for getting prostate cancer. These are:

  • Age - it mainly affects men aged 50 or over
  • Men aged 45 or over with Black or Mixed Black ethnicity
  • Men aged 45 or over with a family history of cancer

Why we published an interim position

In 2016, we published a consensus statement on the best way to use the PSA blood test in asymptomatic men, based on the available evidence, and supported by expert clinical opinion and the opinions of men with lived experience. We are now in the process of reviewing our consensus statement which will take time; we aim to re-publish in Spring 2023.

Since publishing our PSA consensus statements the prostate cancer diagnostic and treatment pathways have changed and continue to evolve - introduction of pre-biopsy mpMRI in the diagnostic pathway, the availability of image guided biopsy and Local Anaesthetic Trans Perineal Biopsy, and increased rates of Active Surveillance for men with localised prostate cancer.

The COVID-19 pandemic has resulted in 14,000 fewer men being diagnosed with prostate cancer. In addition, recent analysis has shown how COVID-19 has changed prostate cancer diagnosis, treatment and mortality in ways that are likely to increase late diagnosis, increase prostate cancer deaths and reduce life expectancy for men with prostate cancer for many yearsxxxv. COVID-19 has increased late diagnosis: 12.7% of diagnoses were metastatic prior to the pandemic compared to 15.5% metastatic during the pandemic.

NHS policy is shifting in reaction to the pandemic and proactive approaches to case finding in men in the highest risk groups are being recommended, alongside pilot projects that take prostate cancer awareness and PSA testing closer to communities at higher risk.

This is an interim position because a large-scale epidemiological study of PSA blood test use in the UK and an evidence review are currently underway; our position will continue to evolve in response to our findings. To keep in touch and hear more about this topic, sign up to our e-newsletter.

Statements 1 and 2:

  • A multiparametric MRI (mpMRI) is now the recommended first-line investigation for men referred with a raised PSA blood test (≥3.0ng/mL).
  • mpMRI is the recognised standard approach with NHS England’s Faster Diagnostic Pathway for prostate cancerii.
  • The use of mpMRI before biopsy has increased, although it has not been fully implemented across the country. In 2019, we submitted a Freedom of Information Request to estimate mpMRI availability and patient eligibility rates. Availability was >95% and the most frequent eligibility rate stated by mpMRI adopters is estimated to be 90%.
  • An mpMRI scan following referral, can rule out up to 27% of men from having a biopsy and can lead to 5% fewer clinically insignificant cancers detected and treatediii.
  • MRI-targeted prostate biopsy can also reduce the diagnosis of clinically insignificant prostate canceriv.
  • Prostate biopsies can have harmful side effects, which in rare cases can include sepsis. Transperineal biopsies are now an option supported by NICEv,vi which carry a lower risk of sepsis. A recent cohort study found that between 2017-2019, 33% of prostate biopsies were transperineal biopsies, and 67% were transrectal biopsies. The sepsis rates were 0.42% for transperineal and 1.12% for transrectalvii.
  • National Prostate Cancer Audit data shows that in 2019 40% of men diagnosed had a Transperineal biopsyviii, rising to 64% 2020ix.
  • Men with localised, low- and low-intermediate risk prostate cancer, eligible for active surveillance, can delay or avoid radical treatment for 10-15 years avoiding associated side-effectsx,xi.
  • Active surveillance for men with localised, clinically insignificant prostate cancer supports the reduction of over-treatment, with similar 10-year mortality outcomes compared to men being radically treatedx. The National Prostate Cancer Audit (NPCA) have reported annual reductions in the rates of ‘over-treatment’ of low-risk disease in England and Wales (12% for men diagnosed 2014/15 to 5% for men diagnosed 2018/19)xii.

Statements 3-6:

Our position is that of informed choice, and we continue to advocate that men should understand their risk factors for prostate cancer, understand the pros and cons of the PSA blood test and use that information to decide if they want a PSA test. We continue to work with NHS colleagues to collaborate and support with local risk awareness campaigns, and sign-post men to our risk checker.

  • In the absence of a national screening programme, we want to reach and activate more men to make an informed choice about their prostate cancer risk. Fully informed men, have a right to a PSA blood test, free from their GPxiv,xv.
  • GPs have a role in counselling asymptomatic men who ask for a PSA blood testxiv.
  • The prostate pathway remains challenged because of the Covid-19 pandemic; treatment numbers for prostate cancer have been the slowest to recover, and prostate cancer referrals have had the slowest recovery of any tumour group other than lung. It is possible that some men with high-risk early-stage prostate cancer will progress to advanced stage disease if their diagnosis is further delayed, thereby losing the opportunity for curative treatment. The NHS in England have introduced a service requirement within the 2022/23 Network Contract Directed Enhanced Service to support early diagnosis through proactive case finding in high-risk menxvi.
  • We have developed an online risk checker that supports men to understand their risk of prostate cancer and the pros and cons of the PSA blood test.
  • Over 1 million people have used the risk checker since it launched in September 2020.
  • Through targeted awareness campaigns, 79% of people completing the risk checker found out they have one or more of the three main risk factors for prostate cancer.
  • 76% of people completing the feedback at the end of the risk checker say that it has helped them make an informed choice about the PSA blood test.
  • NHS England reported in November 2022 a ‘surge in prostate cancer treatments in England’ - Almost 4,000 men received prostate cancer treatment in August (3,898) compared to just over 3,000 in the same month last year (3,057). The surge is attributed to the launch of a joint NHS and Prostate Cancer UK campaign to encourage men to use the charity’s prostate risk checker toolxvii.

Statements 7 and 8 reflect our Black Consensus position. They were established following a consensus process with Black stakeholders including - men with lived experience, Black community leaders, clinicians, researchers and academics with expertise in cancer and ethnicity. These statements reflect the increased risk that Black men face, and the barriers they experience when accessing healthcare.

Statement 7:

  • In England, Black men are at twice the risk of being diagnosed with prostate cancer when compared to white men. 1 in 4 (29.3%) Black men will be diagnosed with prostate cancer in their lifetime, compared to 1 in 8 (13.3%) white menxviii.
  • In England, Black men are at twice the risk of dying from prostate cancer when compared to white men. 1 in 12 (8.7%) Black men will die of prostate cancer, compared to 1 in 24 (4.2%) white menxviii.
  • The PROCESS study found that Black men may be diagnosed with prostate cancer younger compared to white menxix; further highlighting the importance of GPs speaking to Black men about their prostate cancer risk and the PSA blood test.
  • Our 2017 national survey of over 400 GPs revealed only 7% said that they always initiated conversations about prostate cancer with Black men, compared to 27% of men with a family historyxx . We’re supporting healthcare professionals to help change this stat, through our Health Professionals education programme.
  • We also know from our research in 2016 that 86% of Black men didn't know they were twice as likely to be diagnosed with prostate cancer, as any other racial group in the UKxxi. We aim to change this stat by working closely and collaboratively with organisations and communities to support in the delivery of targeted risk awareness campaigns.

Statement 8:

  • We recommend GPs ask men about family history of cancer, including female relatives, and to include that information on the patient’s record to support risk stratification in the future.
  • Previous studies have shown that hereditary prostate cancer is linked to family history of prostate, breast, and ovarian cancerxxii,xxiii,xxiv.
  • Men are two and a half times more likely to get prostate cancer if their father or brother has had it, compared to a man who has no relatives with prostate cancer.
  • A man’s chance of getting prostate cancer may be even greater if their father or brother was under 60 when he was diagnosed, or if they have more than one close relative (father or brother) with prostate cancerxxv.
  • Men’s risk of getting prostate cancer may also be higher if their mother or sister has had breast cancer or ovarian cancerxxvi,xxvii.

Statement 9:

  • There isn’t clear evidence to say how frequently men should have a PSA blood test. European Association of Urology recommend a risk-adapted approach for well-informed men age 50+ with a life-expectancy >10-15 yearsxxviii .
  • Guidelines in other countriesxxix,xxx , have come to similar conclusions, based on European Randomized study of Screening for Prostate Cancer (ERSPC) which used a testing frequency of every four years, or every two years and Göteborgxxxi trial data where men were PSA tested every two years.
  • Ensuring men are aware that a single ‘normal’ PSA blood test can’t rule them out of a future prostate cancer diagnosis is important. This can support men to make initial and future informed choices about the PSA blood test.
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Acknowledgements

Thank you to the following people for collaborating with us on this project so far:

Dr Sola Adeleke
Emmanuel Ahanonu
Stephen Allen
Sarah Ambe
Joe Appiah
Dr Esther Appleby
Kermitt Bentham
Mr Jaimin Bhatt
Karen Bonner
Professor Frank Chinegwundoh MBE
Tony Collier
George Coore
Lorraine Chang Edwards
Dr. Damiette Harry
Junior Hemans
Frank Hird
Mr Oliver Hulson
Denzil James
Enitan Kane
Dr Mike Kirby

 

 

 

Dr Tanimola Martins
Dr. Eva McGrowder
Errol McKellar
Dr Sam Merriel
Donna Miller
Professor Caroline Moore
Ifeoma Nembhardt
Dr Alexander Norman
Henry Obi
Emeka Ojimba
Dr Oluwambunmi Olajide
Dr. Des Powe
Abdoulie Prince Sanyang
Professor Peter Sasieni
Mr Taimur Shah
Michael Thomas
Jeff Thompson
Patrick Williams