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Prostate cancer screening with prostate-specific antigen (PSA) test: a clinical practice guideline

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3581 (Published 05 September 2018) Cite this as: BMJ 2018;362:k3581

Population

Diagnostic pathway for prostate cancer Localised Stage I or II Stage III or IV Advanced Abnormal biopsy and staging No cancer diagnosis Normal biopsy Still possible to have a biopsy and be diagnosed, based on clinical suspicion No Biopsy Biopsy Normal PSA Elevated PSA or Choices considered in this comparison Prostate-specific antigen (PSA) screening No PSAscreening Width of lines proportional to approximate numbers of people Subsequent treatment Surgery Radiation Active surveillance With or withouthormonal therapy Can be followed byradical treatment Men without a previous diagnosis of prostate cancer considering screening

Comparison

or Screening No screening Screening No screening Using prostate-specific antigen testing

We suggest against systematic PSA-based screening for prostate cancer. Either option is reasonable. Shared decision making is needed for men considering screening. Moredetails Strong All or nearly all informed people would likely want this option. Benefits outweigh harms for almost everyone. Weak Most people would likely want this option. Benefits outweigh harms for the majority, but not for everyone. Weak Most people would likely want this option. Benefits outweigh harms for the majority, but not for everyone. Strong All or nearly all informed people would likely want this option. Benefits outweigh harms for almost everyone.

Comparison of benefits and harms

All evidence

With screening With no screening Evidence quality Events per 1000 people Within 10 years No important difference The panel found that these differences were not important for most patients, because the intervention effects were negligible and/or very imprecise (such as statistically not significant)

No important difference All cause mortality Moderate More 129 128

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably has little or no effect on all cause mortality

No important difference Prostate cancer mortality Low More 3 3

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency Serious Publication bias No serious concerns PSA screening may have little or no effect on prostate cancer mortality

7 fewer Incidence of cancer (any stage) Low More 32 39

Risk of Bias Serious Imprecision Because of inconsistency Indirectness No serious concerns Inconsistency Serious Publication bias No serious concerns PSA screening may increase the detection of prostate cancer (any stage)

7 fewer Incidence of localized cancer Low More 19 26

Risk of Bias Serious Imprecision Because of inconsistency Indirectness No serious concerns Inconsistency Serious Publication bias No serious concerns PSA screening may increase the detection of localized cancer (stage I or II)

Incidence of advanced cancer Low More 13 11 No important difference

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency Serious Publication bias No serious concerns PSA screening may have little or no effect on the detection of advanced cancer (stage III or IV)
Within 1 month

Fewer Biopsy-related complications Low More

Among 1000 men with PSA screening, more presented with complications due to prostate biopsies: Blood in semen: 94 Pain: 45 Fever: 19 Hospitalized for sepsis: 1 Blood in urine: 67 Because of uncertainty due to estimating likelihood along the diagnostic pathway
At any time

Fewer Cancer treatment complications Low More

Among 1000 men with PSA screening, more presented with complications due to cancer treatment: Erection not firm enough for intercourse: 25 Urinary incontinence: 3 Because of uncertainty due to estimating likelihood along the diagnostic pathway
See patient decision aids
See all outcomes

Selected evidence at lower risk of bias This section includes only data from the ERSPC trial, conducted in 162 243 participants in 9 European countries

With screening With no screening Evidence quality Events per 1000 people Within 10 years No important difference The panel found that these differences were not important for most patients, because the intervention effects were negligible and/or very imprecise (such as statistically not significant)

No important difference Moderate More 129 129 All cause mortality

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably has little or no effect on all cause mortality

1 fewer Moderate More 3 2 Prostate cancer mortality

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably leads to a small reduction in prostate cancer mortality

18 fewer Moderate More 32 50 Incidence of cancer (any stage)

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably increases the detection of prostate cancer (any stage)

14 fewer Moderate More 19 33 Incidence of localized cancer

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably increases the detection of localized cancer (stage I or II)

13 Moderate More 3 fewer 10 Incidence of advanced cancer

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably slightly decreases the detection of advanced cancer (stage III or IV)
Within 1 month

Low More Biopsy-related complications Fewer

Among 1000 men with PSA screening, more presented with complications due to prostate biopsies: Blood in semen: 94 Pain: 45 Fever: 19 Hospitalized for sepsis: 1 Blood in urine: 67 Because of uncertainty due to estimating likelihood along the diagnostic pathway
At any time

Low More Cancer treatment complications Fewer

Among 1000 men with PSA screening, more presented with complications due to cancer treatment: Erection not firm enough for intercourse: 25 Urinary incontinence: 3 Because of uncertainty due to estimating likelihood along the diagnostic pathway
See patient decision aids
See all outcomes

Men with family history of prostate cancer Family history defined positive if man’s father or at least one brother had been diagnosed with prostate cancer

With screening With no screening Evidence quality Events per 1000 people Within 10 years No important difference The panel found that these differences were not important for most patients, because the intervention effects were negligible and/or very imprecise (such as statistically not significant)

29 fewer Incidence of cancer (any stage) Moderate More 50 79

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably increases the detection of prostate cancer (any stage)

19 fewer 25 Incidence of localized cancer Moderate More 44

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably increases the detection of localized cancer (stage I or II)
See patient decision aids
See all outcomes

Men of African descent

With screening With no screening Evidence quality Events per 1000 people Within 10 years No important difference The panel found that these differences were not important for most patients, because the intervention effects were negligible and/or very imprecise (such as statistically not significant)

Prostate cancer mortality Moderate More 7 1 fewer 6

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably has little or no effect on prostate cancer mortality

29 fewer Incidence of cancer (any stage) Moderate More 51 80

Risk of Bias Serious Imprecision No serious concerns Indirectness No serious concerns Inconsistency No serious concerns Publication bias No serious concerns PSA screening probably increases the detection of prostate cancer (any stage)
See patient decision aids
See all outcomes
Men with these characteristics carry a higher incidence of prostate cancer, and could be at higher risk of dying of prostate cancer. It remains uncertain whether the impact of screening is similar in these higher risk men in comparison to men at lower risk. Men at higher risks There is considerable variability among men's values and preferences regarding prostate cancer screening. Men who place a high value in avoiding complications from biopsies and subsequent treatment are likely to decline screening. In contrast, men who place a higher value in even a small reduction of prostate cancer mortality may opt for screening. Higher risk patients may be more likely to seek screening because they may worry more about prostate cancer and want to rule out the diagnosis. Values and preferences LUTS symptoms like these are common complaints in adult men that can have a major impact on quality of life and substantial economic burden. The aetiology of LUTS is multifactorial, benign prostatic enlargement, due to hyperplasia, being the major cause. Evidence to date indicates that men with LUTS are at no higher risk of prostate cancer than men without LUTS. Lower Urinary Tract Symptoms (LUTS) Key practical issues PSA testing is done with a regular blood sample Usually taken through rectum guided by ultrasound Takes about 5-10 minutes Antibiotics given before procedure Local anaesthesia or sedation given before procedure May have to stop blood thinners before procedure Screening If biopsy is required Slow stream Sensation of incomplete emptying Increased urinary frequency Family history of prostate cancer African descent Poorer socio-economic groups

©BMJ Publishing Group Limited.

Disclaimer: This infographic is not a validated clinical decision aid. This information is provided without any representations, conditions or warranties that it is accurate or up to date. BMJ and its licensors assume no responsibility for any aspect of treatment administered with the aid of this information. Any reliance placed on this information is strictly at the user's own risk. For the full disclaimer wording see BMJ's terms and conditions: https://www.bmj.com/company/legal-information/

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Rapid Response:

Re: Prostate cancer screening with prostate-specific antigen (PSA) test: a clinical practice guideline

On 22nd September 2018 The BMJ carried an article on PSA screening.

It struck me forcibly that there was no mention of fPSA (Free to Total PSA testing)

I wrote to the consultant who literally saved my life in 2009, by requiring this test asking for his view on why he thought it was omitted from the article. He wrote that It is clear that free / total PSA has become redundant for some reason as there is almost no talk of it now. I have no idea why. I agree with your comments regarding its utility in the borderline PSA situation. A paper in ‘Urology’ (an American journal) at https://www.ncbi.nlm.nih.gov/pubmed/12670561 entitled Free/total PSA ratio is a powerful predictor of future prostate cancer morbidity in men with initial PSA levels of 4.1 to 10.0 ng/mL. clearly shows that there is benefit to this test. https://www.healthline.com/health/prostate-cancer-free-psa#purpose is also in accord with our thinking. There is also a very comprehensive article, (that I have glossed over as I have not had time to read in detail) at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1495603/

Knowing that I would have almost certainly died had this test not been performed, and surgery carried out, I wondered whether the writer of your article has any insights into why this was omitted. I wonder if the author might advise please - Kind regards

Louis Shakinovsky

Competing interests: No competing interests

18 November 2018
Manfred Louis Shakinovsky
Chairman Global Dental Services
Dental
London