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PSA: FACT OR FICTION THE DEBATE AS IT STANDS Dr Charles Chabert.

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Presentation on theme: "PSA: FACT OR FICTION THE DEBATE AS IT STANDS Dr Charles Chabert."— Presentation transcript:

1 PSA: FACT OR FICTION THE 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  men  Ages between (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 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 Gleason 6 Gleason >6 Screening Group72.2%27.8% Control group54.8%45.2% Chabert13% 87% (GS=7 74% GS= %) ChabertpT2 (57.6%)pT3 (42.4%) Charles Chabert

11 Prostate Cancer Mortality  31 Dec 2006  Median F/U 9.0 years Charles Chabert CAP Mortality Screening214 deaths Control326 deaths

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 years  Enrolled at 10 centres  PSA> 4.0ng/ml indication for biopsy Charles Chabert

16 Study Design  1:1 randomisation  men Randomized  in Screening group  in control group Charles Chabert

17  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 Study Design 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 6 th year Charles Chabert

20 Results Charles Chabert ScreenedControl Prostate Cancer (7 years) Prostate cancer (10 years) F/U 67% Gleason score % had Gleason 5 or 6

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)  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  “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. Summary Charles Chabert


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