Mr Lyndon Gommersall PSA testing A Primary Care Perspective

1. Mr Lyndon GommersallPSA testing – A Primary Care Perspective Consultant Urological Surgeon University Hospital of North Staffordshire FRCS(Urol) MD

2. Introduction Introduction Diagnosis Follow-up Prostate Cancer Talk Introduction Guidelines Screening Prostate Cancer Risk Management Programme Stable prostate cancer follow up

3. Scrum half for Leeds Carnegie and EnglandScrum half for Leeds Carnegie and England

4. Introduction Introduction Diagnosis Follow-up Prostate Cancer Talk Introduction Guidelines Screening Prostate Cancer Risk Management Programme Stable prostate cancer follow up

5. Introduction Why do Primary Care Perform a PSA? Patients request LUTS? Bone Pain Added to ‘Well Man’ check? Follow up Are we better in Secondary care? Every pt on dialysis had a PSA blood test 3/12ly Audit ‘Taking the PSA’

6. Introduction Community Follow up of Prostate Cancer 3 basic models....... GP with an interest in a practice GP led service in local community e.g. North Staffs and SOT PCT Hospital in the Community Issues Less specialist but redundancy More specialist but no back up if GP ceases to perform clinic. GP must attend MDT More specialist input but complex to set up

8. PSA

9. Prostate Specific Antigen Glycoprotein and enzyme (serine protease) secreted by the epithelial cells of the prostate. Prevents semen coagulation High homology with human glandular kallikrein (hK2) 1cc of BPH makes ~ 0.13ng of total PSA Organ-specific and NOT tumour-specific Can be raised following ejaculation, infections, in BPH – and is lowered by finasteride

10. What is normal ? ‘Reference’/ ‘normal’ ranges 95% confidence intervals ‘Normal’ is falling Age related <50 yrs 2.5 50-59 yrs 3.5 60-69 yrs 4.5 >70 yrs 6.5 Vary between hospitals Ultra-sensitive PSA

11. PSA and Ca.P diagnosis Sensitivity vs specificity PSA < 4 25% chance of cancer on Bx PSA 4-10 30-50% PSA >10 >50% PSA testing will lead to more diagnoses of CaP For example experience in USA since 1987 PSA + DRE is most accurate (another 18% detected)

12. Effects on PSA

13. Improving PSA performance Age-specific PSA ranges Free / Total PSA PSA density PSA velocity Complexed PSA (PSA-ACT; PSA-MCG)

15. Introduction Introduction Diagnosis Follow-up Prostate Cancer Talk Introduction Guidelines Screening Prostate Cancer Risk Management Programme Stable prostate cancer follow up

16. ABOUT THIS PRESENTATION: This presentation has been written to raise awareness of the NICE clinical guideline on Prostate cancer: diagnosis and treatment. This guideline has been written for healthcare professionals and other staff who care for men with prostate cancer. It was updated in May 2009 to incorporate relevant elements of a joint implementations statement agreed between NICE and the British Association of Urological Surgeons (BAUS) These cover Hormonal therapy for biochemical relapse after primary treatment The management of patients with low risk prostate cancer Bisphosphonates and osteoporosis Follow up of men with localised prostate cancer The guideline is available in a number of formats. You can download these from the NICE website or order printed copies of the quick reference guide by calling NICE publications on 0845 003 7783 or sending an email to publications@nice.org.uk. Quote reference number N1457.You should hand out copies of the quick reference guide at your presentation so that your audience can refer to it. You may also find it helpful to refer to the prostate cancer pathway algorithms provided in appendix C of the NICE guideline which can also be downloaded from www.nice.org.uk/CG058 You can add your own organisation’s logo alongside the NICE logo. We have included notes for presenters broken down into ‘key points to raise’ for you to highlight these in your presentation and ‘additional information’ that you may want to draw on . Where necessary the recommendations will be given in full. DISCLAIMER This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself.ABOUT THIS PRESENTATION: This presentation has been written to raise awareness of the NICE clinical guideline on Prostate cancer: diagnosis and treatment. This guideline has been written for healthcare professionals and other staff who care for men with prostate cancer. It was updated in May 2009 to incorporate relevant elements of a joint implementations statement agreed between NICE and the British Association of Urological Surgeons (BAUS) These cover Hormonal therapy for biochemical relapse after primary treatment The management of patients with low risk prostate cancer Bisphosphonates and osteoporosis Follow up of men with localised prostate cancer The guideline is available in a number of formats. You can download these from the NICE website or order printed copies of the quick reference guide by calling NICE publications on 0845 003 7783 or sending an email to publications@nice.org.uk. Quote reference number N1457.You should hand out copies of the quick reference guide at your presentation so that your audience can refer to it. You may also find it helpful to refer to the prostate cancer pathway algorithms provided in appendix C of the NICE guideline which can also be downloaded from www.nice.org.uk/CG058 You can add your own organisation’s logo alongside the NICE logo. We have included notes for presenters broken down into ‘key points to raise’ for you to highlight these in your presentation and ‘additional information’ that you may want to draw on . Where necessary the recommendations will be given in full. DISCLAIMER This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself.

17. BAUS/NICE joint implementation statement (April 2009) Management of patients with low risk prostate cancer Hormonal therapy for biochemical relapse after primary treatment Bisphosphonates and osteoporosis Follow up of men with localised prostate cancer NOTES FOR PRESENTERS: Since its publication BAUS and NICE have had discussions to ensure that there is clarity over some of the recommendations in order to support the implementation of the guideline. The statement applies to:  The management of patients with low risk prostate cancer  It is expected that men with low risk prostate cancer suitable for radical treatment will be told about a range of treatment options including active surveillance, radiotherapy and surgery. This is to ensure that a fully informed joint decision on future care is made by the patient and his doctor. For patients choosing active surveillance, the decision about when and whether to carry out a re-biopsy should be made in consultation with the multi-disciplinary team.   Hormonal therapy for biochemical relapse after primary treatment  In asymptomatic men with biochemical progression after radical treatment, because of long lead times and difficulty in accurately measuring PSA doubling times, hormonal treatment should normally be deferred until PSA doubling times are around 3 months and account should be taken of the actual level of PSA. In men with symptomatic recurrence or with bone metastases, hormone therapy should normally be started at the time these problems are detected.   Bisphosphonates and osteoporosis The use of bisphosphonates to prevent or reduce the complications of bone metastases in men with hormone-refractory prostate cancer is not recommended. Bisphosphonates for pain relief may be considered for men with hormone-refractory prostate cancer when other treatments (including analgesics and palliative radiotherapy) have failed. The oral or intravenous route of administration should be chosen according to convenience, tolerability and cost. Strontium-89 should be considered for men with hormone-refractory prostate cancer and painful bone metastases, especially those men who are unlikely to receive myelosuppressive chemotherapy Bisphosphonates should not be used routinely to prevent osteoporosis in men with prostate cancer receiving androgen withdrawal therapy. However because long term androgen deprivation is associated with osteoporosis, before men start androgen deprivation therapy assessment should normally be made of their individual risk.  Local protocols should be developed which prior to androgen deprivation would include measurement of bone density, and assessment of risk based on site of metastases and which would include triggers for starting chemo-preventative treatment to reduce risk of future bone complications.   Follow up of men with localised prostate cancer.  Healthcare professionals should discuss the purpose, duration, frequency and location of follow-up with each man with localised prostate cancer, and if he wishes, his partner or carers. Men with prostate cancer should be clearly advised about potential longer term adverse effects of treatment and when and how to report them. If agreed between doctor, patient and GP, then men with prostate cancer who have chosen a watchful waiting regimen with no curative intent should normally be followed up in primary care in accordance with protocols agreed by the local urological cancer MDT and the relevant primary care organisation(s). Their PSA should be measured at least once a year.   NOTES FOR PRESENTERS: Since its publication BAUS and NICE have had discussions to ensure that there is clarity over some of the recommendations in order to support the implementation of the guideline. The statement applies to:  The management of patients with low risk prostate cancer  It is expected that men with low risk prostate cancer suitable for radical treatment will be told about a range of treatment options including active surveillance, radiotherapy and surgery. This is to ensure that a fully informed joint decision on future care is made by the patient and his doctor. For patients choosing active surveillance, the decision about when and whether to carry out a re-biopsy should be made in consultation with the multi-disciplinary team.   Hormonal therapy for biochemical relapse after primary treatment  In asymptomatic men with biochemical progression after radical treatment, because of long lead times and difficulty in accurately measuring PSA doubling times, hormonal treatment should normally be deferred until PSA doubling times are around 3 months and account should be taken of the actual level of PSA. In men with symptomatic recurrence or with bone metastases, hormone therapy should normally be started at the time these problems are detected.   Bisphosphonates and osteoporosis The use of bisphosphonates to prevent or reduce the complications of bone metastases in men with hormone-refractory prostate cancer is not recommended. Bisphosphonates for pain relief may be considered for men with hormone-refractory prostate cancer when other treatments (including analgesics and palliative radiotherapy) have failed. The oral or intravenous route of administration should be chosen according to convenience, tolerability and cost. Strontium-89 should be considered for men with hormone-refractory prostate cancer and painful bone metastases, especially those men who are unlikely to receive myelosuppressive chemotherapy Bisphosphonates should not be used routinely to prevent osteoporosis in men with prostate cancer receiving androgen withdrawal therapy. However because long term androgen deprivation is associated with osteoporosis, before men start androgen deprivation therapy assessment should normally be made of their individual risk.  Local protocols should be developed which prior to androgen deprivation would include measurement of bone density, and assessment of risk based on site of metastases and which would include triggers for starting chemo-preventative treatment to reduce risk of future bone complications.   Follow up of men with localised prostate cancer.  Healthcare professionals should discuss the purpose, duration, frequency and location of follow-up with each man with localised prostate cancer, and if he wishes, his partner or carers. Men with prostate cancer should be clearly advised about potential longer term adverse effects of treatment and when and how to report them. If agreed between doctor, patient and GP, then men with prostate cancer who have chosen a watchful waiting regimen with no curative intent should normally be followed up in primary care in accordance with protocols agreed by the local urological cancer MDT and the relevant primary care organisation(s). Their PSA should be measured at least once a year.  

18. Introduction Introduction Diagnosis Follow-up Prostate Cancer Talk Introduction Guidelines Screening Prostate Cancer Risk Management Programme Stable prostate cancer follow up

20. Prostate Cancer ScreeningERSPC vs PLCO

21. PLCOAndriole et al 2009 NEJM 360:1310-9 Mortality results from a randomized prostate-cancer screening trial

22. Population Men aged 55-74 Recruited 1993-2001 Excluded History of PLCO cancer Current treatment for cancer From 1995 – more than 1 PSA test in the previous 3 years

23. Results(by intention to screen analysis) Prostate cancer and prostate cancer mortality

24. Did the two groups receive their intended intervention? Screened group PSA 86% DRE 87% Control group PSA 40% in first year PSA 52% in sixth year As assessed by asking a randomly selected 1% of the control group each year

25. Issues Contamination Biopsy Is it a pre-screened population? Sub group analysis by number of pre-trial PSAs showed no difference -?power PSA cutoff

26. ERSPCSchroder et al 2009 NEJM 360:1320-1328 Screening and Prostate-Cancer mortality in a randomised European study

27. Primary Outcome Rate of death from prostate cancer Evaluated in blinded fashion

28. ERSPC Resultsprostate cancer mortality

29. Results Absolute risk reduction of prostate cancer death at 9 years = 0.71 per 1000 men To prevent 1 prostate cancer death Offer screen to 1410 Screen 1068 Treat 48

30. Context – colorectal cancer screening Colorectal cancer screening with FOB 4 RCTs, 320,000 patients 16% reduction in relative risk of death from colorectal cancer 16,000 deaths annually – 2500 lives saved by screening programme Number needed to screen to prevent 1 death from CRC=1173

31. Context: breast cancer screening Mammography for women aged 50-69 7 RCTs, 500,000 patients 15-20% reduction in relative risk of death from breast cancer ARR 0.05% 12,300 deaths annually – 1500 lives saved by screening programme Number needed to screen to prevent 1 death from breast cancer =2000 Gøtzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews 2006

32. Introduction Introduction Diagnosis Follow-up Prostate Cancer Talk Introduction Guidelines Screening Prostate Cancer Risk Management Programme Stable prostate cancer follow up

35. Prostate Cancer Risk Management Programme Announced Secretary State of Health 2000 GP info pack in 2002 The prostate cancer risk management programme aims to help the primary care team give clear and balanced information to men who request details about testing for prostate cancer.

36. Key recommendations Any man over the age of 50 who asks for a PSA test after careful consideration of the implications should be given one. The PSA should not be added to a list of investigations without a careful explanation of why the test is being performed and its implications

37. Key recommendations Patients with an abnormal PSA should be referred to a specialist to make an informed choice about prostate biopsy. Not all patients with an abnormal PSA should have a prostate biopsy. PSA should be taken in conjunction with other parameters such as FH, ethnicity, prostate size etc.....

38. Change in practice? Survey of PSA testing 2000-1 compared to 2003-4 % GP testing for PSA increased from only 49-51% No real impact on managing risk of prostate cancer Appropriate fudge.

39. Introduction Introduction Diagnosis Follow-up Prostate Cancer Talk Introduction Guidelines Screening Prostate Cancer Risk Management Programme Stable prostate cancer follow up

44. University Hospital of North Staffordshire Developed by Chris Luscombe (Consultant Urologist) and Karen Moore (CNS) Stoke PCT only GPSi – Dr Chadalavada – Hanley Health Centre 3 areas of prostate cancer Follow-up following treatment with curative intent Follow-up with the intent to avoid active treatment Follow-up following treatment with non-curative intent

48. Any Questions ?