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Monique Roobol: Risk Stratification

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European Prostate Cancer Awareness Day 2019

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Monique Roobol: Risk Stratification

  1. 1. PSA and risk stratification How can we identify those men that can benefit from early testing A stepwise approach M.J.Roobol
  2. 2. European Union and ERSPC mortality reduction • 2015: 77,000 PC deaths • ERSPC mortality reduction app. 30% • 0.30 * 77,000 ≈ 23,000 less PC deaths • European population: 515,052,778 • NNI to avoid one PC death: 22,727 NNI = Number Needed to Invite (several times) to avoid one PC death NNI = 1/absolute risk reduction: (77,000/515M) – (54,000/515M) = 1/0.044*1000
  3. 3. Gender • We will only consider men • 0.49*515,052,778 = 252,375,861 • NNI to avoid one PC death: 10,965
  4. 4. Age • Taking into account natural history • Appropriate age range for screening 50/55-75 yr • N= 55,287,068 • NNI to avoid one PC death: 2,400
  5. 5. PSA is a useful biomarker Vickers et al. BMJ 2010;341:c4521 ERSPC Rotterdam, age 55-74 yr, initial screening, N=19,970 PSA % Cum % < 1.0 35.7 35.7 1.0 - < 2.0 31.1 66.8 2.0 - < 3.0 12.6 79.4 3.0 - <4.0 7.1 86.5 4.0 - <10.0 11.2 97.7 >= 10.0 2.3 100.0 • Age 60: 25 yr follow-up: 0.2% risk of death from prostate cancer with PSA < 1.0 ng/ml • Men aged 55-75 ERSPC Rotterdam: 36% had PSA < 1.0 ng/ml • PSA risk stratification: 0,64*55,287,068 = 35,383,723 • 10% less PC deaths avoided • NNS to avoid one PC death: 1,707
  6. 6. Those special cases • For Now: BRCA1/2 or 1st/2nd relative with M+ PCa start at age 40
  7. 7. Guidelines PSA (ng/ml) Age 50-59 % of men Age 60-70 % of men < 1.0 Postpone re-testing at least 5 years 50% Stop further testing 30% 1.0-3.0 Test with 2 to 4 yr interval 40% Test with 2 to 4 yr interval 45% >= 3.0 Reflex testing 10% Reflex testing 25% EAU: http://uroweb.org/guideline/prostate-cancer/?type=pocket-guidelines https://www.mskcc.org/cancer-care/types/prostate/screening/screening-guidelines-prostate
  8. 8. PSA • PSA is suitable as an initial risk stratification tool! • Studies have shown that men (> = 60 yr) with PSA levels < 1.0 ng/ml have very low chance of suffering or dying from PCa (app 30-50% of men): STOP • STOP testing men with limited life expectancy • Men with intermediate PSA should be retested but definitely not every 6 months/year • PSA >= 3.0 ng/ml should NOT directly lead to biopsy (or mpMRI) • Reflex testing!
  9. 9. Effective possibilities Diagnosis of GS >= 7 PCa missed Prostate biopsies avoided Costs per test ($) PCA3 3-13% 46% 450 PHI 5% 36-41% 80 Free-PSA 23% 66% < 80 4K-panel 1.3-4.7% 30-58% 400-1000 STHLM-3 panel 1% 32% 285 Select-MDX 2% 42% 250-290 ERSPC Risk Calculator 12,5% cut-off 1% 33 % < 2 mpMRI targeted prostate biopsy 20% 27% 250-400
  10. 10. And now there is MRI and targeted biopsy Risk stratification before MRI and biopsy can avoid up to 68% of indolent Prostate Cancer overdiagnosis will be solved!
  11. 11. MRI as part of AS represents a significant advance in the oncological safety of the AS protocol !! Incorporation of MRI into surveillance protocols and decreasing the intensity of repeat testing : cost-effective options ! Stratification with MRI and PSA-density reduces unnecessary biopsy testing and early termination of AS !
  12. 12. MRI first … but only after risk stratification • Guidelines will be adapted, MRI as initial risk stratification tool in both biopsy naive men and men with previous negative biopsy. • Need standardisation, training of radiologists and capacity ( financial sources) • Suggested approach: PSA (ng/ml) Age 50-59 % of men Age 60-70 % of men < 1.0 Postpone re-testing at least 5 years 50% Stop further testing 30% 1.0-3.0 Test with 2 to 4 yr interval 40% Test with 2 to 4 yr interval 45% >= 3.0 Reflex testing 10% Reflex testing 25%
  13. 13. NNI in comparison Breast cancer screening 1 Colorectal cancer screening 1 PSA-based Prostate cancer screening 2 Person years 800,000 800,000 825,018 Mortality Screening arm (per 100,000 pers years) 26 60 43 Mortality Control arm (per 100,000 pers years) 42 70 54 Cancer deaths (S-arm) 208 480 355 Cancer deaths (C-arm) 336 560 545 Relative Risk 0.61 (0.45-0.82) 0.85 (0.74-0.98) 0.79 (0.69-0.91) NNS 1968 2175 781 NNT 18 29 27 Risk-based 1 based on the results from published randomised controlled trials of screening for breast cancer and colorectal cancer, for hypothetical populations of 100000. Richardson et al J Med Screening 2001 2 based on ERSPC. Schröder et al. Lancet 2014
  14. 14. What is going on in daily clinical practice?
  15. 15. Conclusions • Combination is key! • PSA is a highly useful biomarker to start with • Reflex testing is next step • MRI is here to stay ! • Before MRI proper risk stratification is mandatory! • With coordinated screening we will be able to • maintain (improve) the prostate cancer mortality reduction • and avoid harms (unnecessary testing and overdiagnosis (MRI based follow-up) and uncertainty, anxiety and costs!

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