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Practice Rapid Recommendations

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

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Find recommendations, evidence summaries and consultation decision aids for use in your practice
  1. Kari A O Tikkinen, chair, urologist, methodologist1 2,
  2. Philipp Dahm, urologist, methodologist3,
  3. Lyubov Lytvyn, patient partnership liaison4,
  4. Anja F Heen, general internist5,
  5. Robin W M Vernooij, methodologist6,
  6. Reed A C Siemieniuk, general internist, methodologist4,
  7. Russell Wheeler, patient partner7,
  8. Bill Vaughan, patient partner8,
  9. Awah Cletus Fobuzi, patient partner9 10,
  10. Marco H Blanker, general practitioner, methodologist11,
  11. Noelle Junod, general practitioner12,
  12. Johanna Sommer, general practitioner13,
  13. Jérôme Stirnemann, general internist14,
  14. Manabu Yoshimura, general practitioner15,
  15. Reto Auer, general practitioner16 17,
  16. Helen MacDonald, general practitioner, editor18,
  17. Gordon Guyatt, general internist, methodologist4,
  18. Per Olav Vandvik, general internist, methodologist5,
  19. Thomas Agoritsas, methods chair, general internist4 14 19
  1. 1Department of Urology, University of Helsinki and Helsinki University Hospital, 00029 Helsinki, Finland
  2. 2Department of Public Health, University of Helsinki, 00014 Helsinki, Finland
  3. 3Urology Section, Minneapolis VAMC and Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA
  4. 4Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
  5. 5Department of Medicine, Innlandet Hospital Trust-division, Gjøvik, Norway
  6. 6Department of Research, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.
  7. 7Cochrane Consumers, London, UK
  8. 8Citizens United for Evidence-Based Medicine, Virginia, USA
  9. 9Cameroon Consumer Service Organization (CamCoSO), Bamenda, Cameroon
  10. 10Coalition of Civil Society Organizations Cameroon, Bamenda, Cameroon
  11. 11Department of General Practice and Elderly Medicine, University Medical Centre-Groningen, University of Groningen, Groningen, The Netherlands
  12. 12Institute of Primary Care, Geneva University Hospitals, Geneva, Switzerland
  13. 13Unit of Primary Care Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland
  14. 14Division General Internal Medicine, University Hospitals of Geneva, Geneva, Switzerland
  15. 15School of Medicine, University of Miyazaki, Miyazaki, Japan
  16. 16Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
  17. 17Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland
  18. 18The BMJ, London, UK
  19. 19Division of Clinical Epidemiology, University Hospitals of Geneva, Geneva, Switzerland
  1. Correspondence to: K A O Tikkinen kari.tikkinen{at}gmail.com

What you need to know

  • PSA testing has increased the number of men diagnosed with and treated for prostate cancer, but many of these men would never have experienced any symptoms or death from prostate cancer

  • This guideline makes a weak recommendation against offering systematic PSA screening based on an updated systematic review. The recommendation is weak because there may be a small, though uncertain, benefit of screening on prostate cancer mortality

  • Men who place more value on avoiding complications from biopsies and cancer treatment are likely to decline screening. In contrast, men who put more value in even a small reduction of prostate cancer mortality (such as men at high baseline risk because of family history or African descent, or those concerned to rule out the diagnosis) may opt for screening

  • Shared decision making is needed for men considering screening to make a decision consistent with their individual values and preferences. However, clinicians need not feel obligated to systematically raise the issue of PSA screening with their patients

What is the role of prostate-specific antigen (PSA) screening in prostate cancer? An expert panel produced these recommendations based on a linked systematic review.1 The review was triggered by a large scale, cluster randomised trial on PSA screening in men without a previous diagnosis of prostate cancer published in 2018 (box 1).2 It found no difference between one-time PSA screening and standard practice in prostate cancer mortality but found an increase in the detection of low risk prostate cancer after a median follow-up of 10 years.

Box 1

Results of the CAP Randomized Clinical Trial2

This cluster-randomised trial of 419 582 British men was published in March 2018. After a median follow-up of 10 years, there was no significant difference in prostate cancer-specific mortality in men receiving care by general practices randomised to a single PSA screening intervention compared with men receiving care …

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