1. PSA Consensus and The Prostate Cancer Risk Management Programme Karen Stalbow, Prostate Cancer UK Dr Ali Cooper, Prostate Cancer UK Annual Conference 2016 1

2. PSA testing in asymptomatic men – updated guidelines Karen Stalbow – Head of Policy, Knowledge & Impact, Prostate Cancer UK Dr Ali Cooper – Knowledge Manager, Prostate Cancer UK 2

3. Improving diagnosis Men affected by prostate cancer tell us: One of the biggest problems we need to fix is diagnosis 3

4. Setting the scene Prostate Cancer UK’s work to improve the use of the PSA test and its relationship with the national prostate cancer risk management guidance Our presentation focus: 4

5. UK NSC http://legacy.screening.nhs.uk/prostatecancerhttp://legacy.screening.nhs.uk/prostatecancer January 2016 5

6. Prostate Cancer Risk Management Programme https://www.gov.uk/guidance/prostate-cancer-risk-management-programme-overviewhttps://www.gov.uk/guidance/prostate-cancer-risk-management-programme-overview March 2016 6

7. Prostate Cancer Risk Management Programme https://www.gov.uk/guidance/prostate-cancer-risk-management-programme-overviewhttps://www.gov.uk/guidance/prostate-cancer-risk-management-programme-overview March 2016 Previous PCRMP guidance: 2016 PCRMP guidance: “Besides the wide-ranging PSA references that exist in the literature, the PCRMP also recognises that there is a wide range of referral practice throughout the UK. Before a consensus can be found, the previously recommended age- related referral values by the Programme are being reconsidered given the concern of missing a high proportion of clinically significant cancers in older men (low sensitivity) and the increase rate of unnecessary biopsies in younger men (low specificity). Recommended prostate biopsy referral values are being realigned to the evidence emerging from these two trials [ERSPC & PLCO]” And what about 70+ men? 7

8. Consensus statements (1) The gaps: -Referral threshold for men under 50 -How often to re-test a man with a ‘normal’ PSA result and what this should be based on -What should trigger a referral in men undergoing repeat PSA testing -Whether the above should vary for men at higher than average risk (Black men and men with a family history of prostate cancer) How did we gather consensus? -Steering group with independent Chair -Delphi consensus survey (n=335) -Focus groups with men with prostate cancer -Steering Group meeting -User testing with HCPs and men without prostate cancer – inc a dedicated group for Black men http://prostatecanceruk.org/PSAconsensusHPhttp://prostatecanceruk.org/PSAconsensusHP March 2016 8

9. Consensus statements (2) http://prostatecanceruk.org/PSAconsensusHPhttp://prostatecanceruk.org/PSAconsensusHP March 2016 “A man’s PSA level should be built into a validated risk assessment tool alongside other known risk factors to better assess a man’s risk of prostate cancer and aid in the decision-making process” 9

10. Consensus statements (3) Statement 1: A man’s PSA level should be built into a validated risk assessment tool, when available, alongside other known risk factors to better assess a man’s risk of prostate cancer and aid in the decision-making process. Statement 2: Primary healthcare professionals need to be aware of the factors that put men at higher than average risk of prostate cancer. Statement 3: Primary healthcare professionals need to be prepared to have proactive conversations with men at higher than average risk of prostate cancer about prostate cancer risk and the PSA test. http://prostatecanceruk.org/PSAconsensusHPhttp://prostatecanceruk.org/PSAconsensusHP March 2016 10

11. Consensus statements (4) http://prostatecanceruk.org/PSAconsensusHPhttp://prostatecanceruk.org/PSAconsensusHP March 2016 Statement 4: Governments and public health agencies have primary responsibility for raising awareness of prostate health and prostate cancer risk factors amongst men in the UK, with relevant contribution from healthcare professionals and charities. Statement 5: All men should be able to access PSA testing from the age of 50, but men at higher than average risk of prostate cancer should be able to access the PSA test from the age of 45. Statement 6: When a PSA test is being considered, primary healthcare professionals should provide balanced information on the pros and cons of the PSA test in order to allow the man to make up his own mind on whether to have the test. 11

12. Consensus statements (5) http://prostatecanceruk.org/PSAconsensusHPhttp://prostatecanceruk.org/PSAconsensusHP March 2016 Statement 7: Asymptomatic men with a life expectancy clearly less than 10 years should be recommended against an initial or repeat PSA test as they are unlikely to benefit. Statement 8: GPs should offer a digital rectal examination (DRE) to all asymptomatic men who have decided to have a PSA test. Statement 9: Asymptomatic men at higher than average risk of prostate cancer who have a PSA test between the ages of 45 and 49 should be referred for further investigations if their PSA level is higher than 2.5ng/ml. Statement 10: PSA history and a rising PSA (whilst still under the referral threshold) should be taken into consideration when deciding whether to refer to secondary care. 12

13. Consensus statements (6) http://prostatecanceruk.org/PSAconsensusHPhttp://prostatecanceruk.org/PSAconsensusHP March 2016 Statement 11: Asymptomatic men who have a PSA level below the threshold referral value should not be denied a repeat PSA test. Re-testing intervals should be individualized following a discussion incorporating prostate cancer risk factors. Statement 12: Asymptomatic men over 40 should consider a single “baseline” PSA test to help predict their future prostate cancer risk. Statement 13: The PSA test, even when combined with the DRE, should not be used in a UK population-wide screening programme for asymptomatic men. 13

14. Launch & next steps National and trade media coverage Information for the public Summary leaflet & PSA Resource Pack (in Professional Resources section of our website) Journal article submission Primary HCP survey in Autumn ‘Tell us about your experience’ web form for men who have discussed the PSA test with their GP Risk assessment tool development (search “risk tool” on our website) 14

15. How can we work together? Survey of men’s experience of discussing the PSA test with their GP (developed & disseminated with help from Tackle) Online: Print: https://changedelivery.typeform.com/to/x98ksb Continue to get men to tell us about their PSA test conversation experiences Support our Change Delivery team to promote the PSA test consensus statements in the areas where men tell us their PSA test conversations were poor 15

16. Questions? evidence@prostatecanceruk.org 16