Presentation is loading. Please wait.

Presentation is loading. Please wait.

PSA: Fact or Fiction The debate as it stands

Similar presentations

Presentation on theme: "PSA: Fact or Fiction The debate as it stands"— 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 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
160 men died between identification and randomization Mean age at randomisation wa 60.8 years Little variation amongst countries 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 in control group Cumulative incidence of 8.2% and 4.8% respectively Incidence of bone scan positivity was 0.23 vs 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 Group 72.2%
27.8% Control group 54.8% 45.2% Chabert 13% 87% (GS=7 74% GS= %) pT2 (57.6%) pT3 (42.4%) Charles Chabert

11 Prostate Cancer Mortality
31 Dec 2006 Median F/U 9.0 years CAP Mortality Screening 214 deaths Control 326 deaths Charles Chabert

12 ERSPC Divergence of curves at 7-8 years that continues 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 76 793men Randomized
in Screening group 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 Screened Control Prostate Cancer (7 years) 2820 2322
F/U 67% 3452 2974 Gleason score 8-10 289 341 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 Pilot studies to assess for logistics Contamination etc Conducted between Both centers had pilot studies 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 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

Download ppt "PSA: Fact or Fiction The debate as it stands"

Similar presentations

Ads by Google