Prostate Cancer Screening: Are We There Yet? March 2010 Andrew M.D. Wolf, MD University of Virginia School of Medicine

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1 Prostate Cancer Screening: Are We There Yet? March 2010 Andrew M.D. Wolf, MD University of Virginia School of Medicine

2 Case #1 A 55 yo white man with well-controlled hypertension presents for his annual check-up. He has no family history of prostate cancer. After learning the potential risks & benefits, he chooses to be screened for prostate cancer: PSA: 1.0; DRE: abnormal (nodule)

3 Case #2 A 65 year old black man with well-controlled hypertension presents for his annual check-up. No family history of prostate cancer. After learning of the potential risks & benefits, he also elects to be screened: PSA 2.5; DRE normal

4 Case #3 A 74 yo white man with moderately severe COPD, stable CAD, and CHF with an exacerbation last year, currently wellcompensated, presents for his annual check-up. He, too, is interested in prostate cancer screening.

5 Objectives To address six key questions relevant to prostate cancer screening: 1) Does prostate cancer screening work? 2) How good are the screening tests? 3) Who is at greatest risk for clinically important prostate cancer? 4) What are the downsides to screening? 5) Who shouldn t be screened? 6) What do we need to tell our patients?

6 Does prostate cancer screening work? Does screening lead to reduced prostate-cancer specific mortality and/or morbidity?

7

8 The PLCO 73,000 men aged 55 to 74 randomized to screening annually vs routine follow-up Began in 1993, ten U.S. Centers Median follow-up about ten years

9

10

11 PLCO Results Bottom line no difference in death rates at 10 years between intensively screened and lessintensively screened men. Major problems with study 52% contamination rate: more than half of controls were screened Many were screened prior to study entry & had significantly reduced risk of prostate cancer death Fewer than 50% of those with positive screen had prostate biopsy. Study is not complete: further results forthcoming.

12

13 The ERSPC 162,000 men aged 55 to 69 randomized to screening vs routine follow-up (there was no standardized protocol) Began in 1991, seven countries Median follow-up about nine years Prostate cancer death rate 20% lower in screened group P=.04 (statistically significant) Number needed to screen to save 1 life ~ 1000 Number needed to treat to save 1 life: 48 (overtreatment)

14 Absolute risk reduction of 0.71 PCA death per 1000 men after 8.8 years, translating into a 20% reduction in risk of cancer death. Compliance rate of 82% for screening.

15 Issues with ERSPC Positive finding 20% fewer prostate deaths in screened group. Negative findings to prevent one prostate cancer death, one needs to: -Screen 1068 men -Treat 48 men (over-treatment) Is the study negative or positive?

16 How good are the screening tests?

17 How Good Is the PSA*? Test Characteristic PSA (normal <4 ng/ml) Test Positivity (%) 12 Cancer Detection Rate (%) 3 Sensitivity (%) 21 Sensitivity (%) for High Grade Cancer 51 Specificity (%) 91 Positive Predictive Value (%) 30 *Gold standard = prostate biopsy Thompson IA, et al. JAMA 2005 ; 294 :

18 An inconvenient truth

19 PSA>4.0 Your PSA is elevated. You need a biopsy. PSA<4.0 Your PSA is normal. No testing is necessary.

20 Prostate Ca in Men with PSA <4.0ng/ml % with Prostate Cancers n= < PSA Level (ng/ml) In another biopsy study, 25% of men with PSA had cancer, 2/3 of which were clinically significant.* Adapted from Thompson I. N Engl J Med 2004;350: ; *Babaian RJ. J Urol2001;165:757.

21 Population Screening with PSA True Outcomes 4.0+ <4.0 PSA % Positive biopsy 25% High grade 19% Screen 10,000 Men PSA Cancer 190 High grade 36 Normal PSA 92.4% Positive biopsy 15% High grade 15% PSA < Cancer 1386 High grade 208 PSA SEER, PCAW, Prostate Cancer Prevention Trial Data

22 Bottom line: there is no PSA level that reliably discriminates between cancer and non-cancer.

23 The DRE Poorly studied compared with PSA. PLCO study included annual DRE: negative study ERSPC did not include DRE: positive study Positive predictive value only 21%. ~ 18% of cancers are found by DRE with PSA<4. Highly operator-dependent most data come from urologist-based studies likely more accurate than primary care providers American Cancer Society now recommends PSA with or without DRE for men who choose screening.

24 How often should we screen? PLCO study used annual PSA interval: negative study ERSPC used q.2-4 year interval: positive study From modeling studies, going from annual to q. 2 yr PSA Reduces unnecessary biopsies by 50% Reduces over-diagnosis by 13% Retains 87-95% of lives saved ACS now recommends q.2 year interval if initial PSA < 2.5; annual if PSA > 2.5 ng/ml J Urol 1999;162: ; JAMA 2000;284: ; J Natl Cancer Inst 2007;99:1296; Gulati R. Biostatistics 2010, in press.

25 Who is at greatest risk for clinically important prostate cancer?

26 When cure is possible, is it necessary and when cure is necessary, is it it possible? --Willett Whitmore, MD, 1990

27 Prostate Cancer Risk Factors PSA Age Race Family History Abnormal Digital Rectal Examination Prior biopsy (negative = lower risk)

28 How do we use these risk factors? ACS 2010 Guideline Reasonable to continue using a PSA threshold of 4.0 ng/ml to refer for biopsy. For men with PSA in the indeterminate range of ng/ml, consider an individualized risk assessment that integrates the other risk factors A risk calculator can be helpful to quantify risk of cancer, particularly high-grade cancer.

29

30 What are the downsides to screening?

31 Risks of Screening Anxiety among positive screenees Morbidity of biopsy Morbidity/mortality of treatment Labeling effect

32 Impact of a False (+) PSA* % of Respondents Worried Perceived High Ca Risk Life Better False + Normal *High PSA led to normal biopsy vs normal PSA controls, surveyed 6 wks later McNaughton-Collins M. Am J Med 2004;117:719-25

33 Downsides to Early Intervention Radical Radiation Prostatectomy (External) Mortality 0.3-2% % Impotence 20-85% 20-67% Incontinence 1-49% 1-7% Rectal Injury 1-3% 2-23% Urethral/ Bladder Injury 10-18% 3-17%

34 Who shouldn t be screened?

35

36 Life Expectancy for Men Years Age (years) Top 25th Percentile 50th Percentile Lowest 25th Percentile Walter LC. JAMA 2001;285:

37 Current Recommendations for Prostate Cancer Screening USPSTF &AAFP: Insufficient data to recommend for or against screening) D Recommendation for men > 75 years moderate certainty harms > benefits (changed from I in 2008) ACS (2010): Informed decision making, starting at age 50, or 45 if (+) FH or African American ACP: discuss benefits & risks of screening & let pt decide (1997 guideline, now inactive ) Consensus: no screening if life expectancy < 10 yrs

38 What do our patients need to know to decide whether to screen?

39 What Our Patients Need to Know Prostate cancer is an important health concern. PSA can find cancer earlier than we otherwise would. Early detection MAY reduce your chance of dying from prostate cancer, BUT: Most men whose cancer is detected by screening will die of something else before the cancer ever harms them. Treating cancer found by screening often causes problems with erections, urinary control, and/or bowel function.

40 To Help Our Patients Decide: Values Matching Scenarios You might want to be tested if you value finding cancer early, you are willing to be treated without definite expectation of benefit, and you are willing to risk significant injury to sexual, urinary, or bowel function. You might not want to be tested if you place a higher value on avoiding the potential harms of screening, such as anxiety or injury to sexual, urinary or bowel function.

41 What if I don t have time to discuss benefits and risks of screening? Prostate Cancer Screening: A Decision Guide (CDC) Booklet, includes focus on African American men (free) ( htm) Prosdex: A PSA Decision Aid (Cardiff University, UK) Web-based tool, multimedia ( Prostate Cancer Screening: Should you get a PSA test? (Mayo) ( ) Should I Be Tested for Prostate Cancer? (ACS) Booklet (

42 Case #1 A 55 yo white man with well-controlled hypertension presents for his annual check-up. He has no family history of prostate cancer. After learning the potential risks & benefits, he chooses to be screened for prostate cancer: PSA: 1.0; DRE: abnormal (nodule) He would generally be referred for biopsy

43

44 Case #2 A 65 year old black man with well-controlled hypertension presents for his annual check-up. No family history of prostate cancer. After learning of the potential risks & benefits, he also elects to be screened for prostate cancer: PSA 2.5; DRE normal He would generally be reassured that his testing is normal

45

46 Case #3 A 74 yo man with moderately severe COPD, stable CAD, and CHF with an exacerbation last year, currently well-compensated, presents for his annual check-up. He, too, is interested in prostate cancer screening. This man s life expectancy is well below 10 years; you counsel him that finding & treating prostate cancer is more likely to harm him than help him.

47 Conclusions There may be a survival benefit to screening in men with life-expectancies of at least 10 years, but the evidence is conflicting. Most men with screen-detected prostate cancers will die of something else before their cancer would have killed them. There is no PSA threshold that reliably separates cancer from non-cancer. Consider individualized risk assessment when PSA ng/ml Can screen less frequently (q.2yrs) if PSA low (<2.5) Informed- and shared-decision making is critical decision aids can take the burden off you.

48 Selected References Lin K, et al. Benefits and harms of prostate-specific antigen screening for prostate cancer: an evidence update for the U.S. Preventive Services Task Force. Ann Intern Med 2008;149: American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update CA: Cancer J Clin 2010, available on-line ahead of print. Ilic D, et al. Screening for prostate cancer. Cochrane Database Syst Rev. 2006;3:CD Andriole GL, et al. Mortality results from a randomized prostate-cancer screening trial. NEJM 2009;360: Schroder FH, et al. Screening and prostate-cancer mortality in a randomized European study. NEJM 2009;360: Risk Calculator:

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