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Prostate Screening in 2009: New Findings and New Questions

Prostate Screening in 2009: New Findings and New Questions. Durado Brooks, MD, MPH Director, Prostate and Colorectal Cancer. Screening Recommendations. ACS Screening Guidelines - Process. All American Cancer Society cancer prevention. ACS Screening Recommendations.

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Prostate Screening in 2009: New Findings and New Questions

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  1. Prostate Screening in 2009:New Findings and New Questions Durado Brooks, MD, MPH Director, Prostate and Colorectal Cancer

  2. Screening Recommendations ACS Screening Guidelines - Process All American Cancer Society cancer prevention

  3. ACS Screening Recommendations Prostate Cancer Early Detection Guidelines Men age 50 and over with at least a 10 year life expectancy should receive information regarding possible benefits and limitations of finding and treating prostate cancer early, and should be offered both the PSA blood test and digital rectal exam annually Men in high risk groups (African Americans, men with close family members---fathers, brothers, or sons---who have had prostate cancer diagnosed at a young age) should be informed of the benefits and limitations of testing and be offered testing starting at age 45

  4. What are Tests for Prostate Cancer? . Testing Controversy • Types of Tests • Diagnostic Tests - Tests done because of an identified problem (disease is suspected) • Screening Tests -Test done on people who have no symptoms of disease • There is widespread agreement on the use of diagnostic tests for prostate cancer • Screening for prostate cancer is much more controversial

  5. Does screening for Prostate Cancer save lives? Key Questions • Does screening extend men’s lives (are there benefits)? • Does screening lead to health problems (are there harms)? • Do the benefits outweigh the harms?

  6. Does screening for Prostate Cancer save lives? . Changes in the PSA Era • Tyrol, Austria 42% mortality reduction • Olmstead County, Minnesota 22% mortality reduction • SEER Decreased mortality in white men • Department of Defense Increased early stage disease

  7. Five-year Relative Survival (%)* during Three Time Periods By Cancer Site All sites 50 53 66 Breast (female) 75 79 89 Colon 51 59 65 Leukemia 35 42 49 Lung and bronchus 13 13 16 Melanoma 82 86 92 Non-Hodgkin lymphoma 48 53 63 Ovary 37 40 45 Pancreas 2 3 5 Prostate 69 76 100 Rectum 49 57 66 Urinary bladder 73 78 82 1984-1986 1996-2002 Site 1975-1977 *5-year relative survival rates based on follow up of patients through 2003. †Recent changes in classification of ovarian cancer have affected 1996-2002 survival rates. Source: Surveillance, Epidemiology, and End Results Program, 1975-2003, Division of Cancer Control and Population Sciences, National Cancer Institute, 2006.

  8. Does screening for Prostate Cancer save lives? . • Prostate cancer death rates have fallen during the PSA era, but it is not clear this is primarily due to screening • Other possible reasons for this decline: • Disease is found earlier because of • increased awareness • utilization of diagnostic PSA testing • Improved treatments

  9. Does screening for Prostate Cancer save lives? . Limitations of screening • False negative results • False positive results • Overdiagnosis

  10. Does screening for Prostate Cancer save lives? . Limitations of screening • False negative results • PSA and DRE “normal”, but cancer is present • May lead to false reassurance, delayed diagnosis • Research has shown that no cut-off value of PSA is completely reliable to rule-out cancer • Prostate Cancer Prevention Trial end of study biopsies found cancer in some men with PSA less than 1.0 ng/ml

  11. Population Screening with PSA 4.0+ Screen 10,000 Men PSA 4+ 760 Cancer 190 High grade 36 PSA <4 9240 Cancer 1386 High grade 208 PSA 4+ 7.6% Positive biopsy 25% High grade 19% <4.0 “Normal PSA” 92.4% Positive biopsy 15% High grade 15% PSA SEER, PCAW, Prostate Cancer Prevention Trial Data

  12. Does screening for Prostate Cancer save lives? . Limitations of screening • False negative results • False positive results • PSA and/or DRE abnormal, but no cancer found • Can lead to worry, additional tests, and increased costs

  13. Limitations of Prostate Cancer tests False positive results If 100 men in each age group are tested: False Positives = high PSA, but no cancer

  14. Does screening for Prostate Cancer save lives? . Limitations of screening • False negative results • False positive results • Overdiagnosis • Some (many?) cancers found by screening grow very slowly and will never cause problems

  15. Risk of Prostate Cancer Diagnosisby Age and by Race/Ethnicity

  16. Risk of Death From Prostate Cancer by Age and by Race/Ethnicity

  17. Does screening for Prostate Cancer save lives? . New Findings in Screening Results from 2 major, long-term studies reported this year – their findings conflict • ERSPC (European Randomized Screening for Prostate Cancer) • PLCO (Prostate, Lung, Colon and Ovarian)

  18. ERSPC Began in 1991 in seven European countries 162,000 men aged 55 to 69 randomized to screening vs usual care Median follow-up about nine years

  19. ERSPC Findings • More cancers detected with screening • 5990 cancers in screening group • 4307 cancers in control group • Fewer prostate cancer deaths in screening group • 261 deaths in screening group • 363 deaths in control group • Conclusion: 20% lower prostate cancer deaths in screening group

  20. ERSPC Multiple concerns/questions: Minimal-to-no participation of men of African origin Different screening and follow-up protocols Different PSA levels and DRE usage Variable treatment and outcomes (quality questions) To prevent one prostate cancer death 1410 men screened 48 men treated (with attendant risks, side-effects, complications) Bottom line Screening every 4 years, with PSA threshold of 3 ng/ml may decrease chance of prostate cancer death Unclear how this correlates to current U.S. pattern of annual screening with different PSA “triggers” (2.5 – 4.0 ng/ml) High level of overdiagnosis and overtreatment with this approach (although these numbers are likely to go down after longer follow up period) Relevance of findings to African American men unclear

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

  22. PLCO Findings • At 7 years, screening found more cases of cancer • 2,820 prostate cancers in annual screening group • 2332 cases in “usual care” group • More prostate cancer deaths in screening group • 7 years: 50 deaths among annually screened compared with 44 in usual care group • 10 years: 92 deaths in annually screened vs 82 in usual care • Conclusion – No mortality benefit with screening • Prostate cancer deaths similar in both groups • Overall death rate slightly higher in screened (not statistically significant)

  23. PLCO Questions/concerns with study 44% of men had at least one PSA test prior to study May have excluded more aggressive prevalent cancers Selectively included men with prostate cancers not detected by PSA screening (bias against showing a screening effect) Many men in the “usual care” group were screened during the course of the study Initially powered for 20% contamination, later revised to 38% PSA screening in control group : 40% first year; 52% by year 6 Less than half of those with a positive screen result had a biopsy Insufficient African American participation (< 5%) to allow specific analysis of outcomes in this group Bottom line – no difference in death rates at 10 years between intensively screened and less-intensively screened men Relevance of these findings to African American men is unclear

  24. Treatment Options New Findings in Treatment JAMA, September 2009

  25. Watchful Waiting Study published September 2009 • 14,500 men aged 65 + with localized prostate cancer • No active treatment for at least 6 mos following prostate cancer diagnosis • At 10 years, 9% of men had died of prostate cancer • 1017 men died of prostate cancer • 5721 men died of other causes • 7420 men still alive Approximately 11% African Americans in study population, but authors did not report findings separately for this group

  26. False positives are common. • Overdiagnosis and overtreatment is a problem, but magnitude is uncertain. • Treatment-related side effects are fairly common. Summary PotentialBenefits PotentialHarms • PSA screening detects cancers earlier. • Treating PSA-detected cancers may be more effective, but this is uncertain. • PSA may contribute to the declining death rate but the extent is unclear

  27. Screening Recommendations Current ACS Screening Guidelines Men age 50 and over with at least a 10 year life expectancy should receive information regarding possible benefits and limitations of finding and treating prostate cancer early, and should be offered both the PSA blood test and digital rectal exam annually Men in high risk groups (African Americans, men with close family members---fathers, brothers, or sons---who have had prostate cancer diagnosed at a young age) should be informed of the benefits and limitations of testing and be offered testing starting at age 45

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