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PSA: Fact or Fiction The debate as it stands

PSA: Fact or Fiction The debate as it stands. Dr Charles Chabert. PSA Screening. Charles Chabert. European randomised Screening for Prostate Cancer. Charles Chabert. ERSPC. Initiated in early 1990s Aim was to evaluate the effect of PSA screening on death rate from prostate cancer

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PSA: Fact or Fiction The debate as it stands

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  1. PSA: Fact or FictionThe debate as it stands Dr Charles Chabert

  2. PSA Screening Charles Chabert

  3. European randomised Screening for Prostate Cancer Charles Chabert

  4. ERSPC • Initiated in early 1990s • Aim was to evaluate the effect of PSA screening on death rate from prostate cancer • Specifically whether PSA screening could reduce the mortality of CAP by 25% Charles Chabert

  5. Methods • 182000 men • Ages between 50-74 (core group 55-69yr) • Seven European countries • Randomly assigned into group offered PSA screening on average every 4 year • Control group that received no screening Charles Chabert

  6. Study Design • Power of 86% to show a statistically significant difference of 25% or more in prostate cancer specific mortality with a p value of 0.05 • Basis of F/U through to 2008 • On basis of overall level of compliance of 82% & 20% contamination in the control group a 25% reduction in CAP mortality in screening arm equates to 14% reduction on intention to screen

  7. Randomisation Charles Chabert

  8. Screening tests and indications for biopsy • Most centres used PSA cut-off of >4.0ng/ml • Some centres also used DRE and F/T ratios • In Finland PSA cut-off of 10.0ng/ml between 1991-1994 was initially used • Initially sextant biopsies, in June 1996 these were lateralised • Italy transperineal biopsies Charles Chabert

  9. Results • 5990 CAPs detected in screening group and 4307 in control group • Cumulative incidence of 8.2% and 4.8% respectively • Incidence of bone scan positivity was 0.23 vs 0.39 per 1000 in SCR vs CON • 41% reduction in Sc group (p<0.0001) Charles Chabert

  10. Results TRUS Biopsy Charles Chabert

  11. Prostate Cancer Mortality • 31 Dec 2006 • Median F/U 9.0 years Charles Chabert

  12. ERSPC Charles Chabert

  13. Results: Intention to screen analysis • PSA screening : significant 0.71 prostate-cancer deaths per 1000 after median F/U 9 years • Relative reduction of 20% of CAP related death for men between ages of 55-69years • 1410 need to be screened to prevent 1 death • 48 men treated • This can be reduced by not treating indolent cancers Charles Chabert

  14. Prostate, Lung, Colorectal and Ovarian screening trial ( PLCO) Charles Chabert

  15. Study Design • Exclusion criteria: • History of PLCO cancer, current cancer treatment and from 1995 having had >1 PSA test in preceding 3 years • Between ages 55-74 years • Enrolled at 10 centres • PSA> 4.0ng/ml indication for biopsy Charles Chabert

  16. Study Design • 1:1 randomisation • 76 793men Randomized • 38 343 in Screening group • 38 350 in control group Charles Chabert

  17. Study Design • 91% and 98% power to show a 25% and 30% reduction in CAP mortality • Assumption of 100% compliance with the assignment of screening and control • No reference made to the power of the study at time of this analysis Charles Chabert

  18. PLCO Charles Chabert

  19. PLCO Results • Median F/U 11.5 years • Compliance 85% • PSA screening in control group 40% in first year • Increased to 52% in 6th year Charles Chabert

  20. Results 50% had Gleason 5 or 6 Charles Chabert

  21. PLCO Results Charles Chabert

  22. Results Charles Chabert

  23. Conclusion • PSA screening associated with 22% increase in CAP diagnosis • Compliance with screening 85%( expected 90%) • No change on CAP mortality Charles Chabert

  24. Results Charles Chabert

  25. ERSPC & PLCO • Similar goals for both studies • Pilot studies in both • Screening: execution of biopsies under study group not clinical judgement • Treatment left to regional centres • ERSPC 4 yearly PSA ( Sweden 2 yr) • PLCO Pre-randomisation limited to 1 in prior 3 years • Annual PSA & DRE then 2 yrs PSA • Regional centres made call on TRUS Charles Chabert

  26. Take Home Points • ERSPC shows effect of screening on CAP mortality at 9 years • This amounts to 20% on intention to treat analysis and 31% for men who are screened • ERSPC NNT=48 • PLCO shows no difference Charles Chabert

  27. Lancet Oncology (online early publication) • 20 000 men Randomised (Swedish cohort from ERSPC) Median upper limit screening 69 (67-71) Primary end point prostate cancer specific mortality First planned report Median F/U 14 years CAP incidence 12.7% vs 8.2% RR in CAP death 44% 293 men need to be screened 12 diagnosed to prevent 1 CAP death Charles Chabert

  28. CAP Mortality Charles Chabert

  29. Summary • “GPs should be offering a PSA test to 40 year old men in conjunction with a digital rectal examination (DRE) after discussing with them the subsequent potential issues.” • “Those identified as being at higher risk should undergo regular tests; those at low risk should consider less frequent testing.” Charles Chabert

  30. Summary • “A PSA level higher than 0.6 in a 40 year old is considered higher risk, as is a level of higher than 0.7 in a 50 year old, and regular monitoring is recommended for these groups. • “There is firm data that PSA testing reduces the risk of being diagnosed with advanced disease, and that treatment of prostate cancer at an early stage can lead to a reduced risk of death. Charles Chabert

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