2017 USPSTF Draft Recommendations for Prostate Cancer Screening Michael R. Zaragoza, MD

USPSTF and Prostate Cancer 2002: Inadequate evidence for or against screening (Grade I) 2008: Advised against screening men > 75 yo 2012: Advised against screening all men (grade D recommendation) 2017: Advised avg risk men 55-69 to discuss screening with their physician (Grade C)

2017 Draft Recommendations Clinician inform men ages 55-69 about benefits/harms of PSA-based screening Decision to be screened for prostate CA should be individual one Individualized decision-making w clinician to understand potential risk and benefits and incorporate patient’s own values and preferences Recommend against PSA screening for men 70 years and older

2017 USPSTF Draft Benefits of Treatment (3 trials) ProtecT: 1600 men, 50-69yo RRP and XRT compared to AS: Significant reduction of progression to mets PIVOT: RRP vs observation Decreased mortality with surgery if PSA>10. Scandanavian Prostate Cancer Group-4: RRP vs. WW Decreased prostate cancer-specific mortality

2017 USPSTF Draft Harms of Screening Harms of Treatment False Positives (15%) Complications of prostate biopsy (1% hospitalization) Harms of Treatment Impotence (>50%) Urinary Incontinence (20% long term) Bowel symptoms (15%)

2017 Draft Recommendations Clinician inform men ages 55-69 about benefits/harms of PSA-based screening Decision to be screened for prostate CA should be individual one Individualized decision-making w clinician to understand potential risk and benefits and incorporate patient’s own values and preferences Recommend against PSA screening for men 70 years and older

2017 USPSTF Draft What is Different? Grade “D” -> “C” And Why? 1. Acknowledge a net benefit in screening men 55-69, which should be balanced with potential harms 2. Individualized decision reflecting each man’s values and preferences regarding benefits and harms And Why? -Updated evidence from largest trial at 13 yrs: PSA screening continues to shows a reduction in prostate cancer mortality -Harms may be mitigated by newer approach of Active Surveillance

2017 USPSTF Draft What is Different and Why? Evidence Based: Updated ERSPC and PLCO trials 1. ERSPC: Screened men 30% less like to die from CAP & 35% less likely to get metastatic disease FU at 13yrs : 1-2 men/1000 screened to prevent death FU at 12 yrs : 3.1/1000 screened to prevent metastasis 2. PLCO: Recognized flaws in initial trial which concluded no difference in mortality for those screened

Active Surveillance 2005-2009: 10% 2010-2013: 40% Active Surveillance Trends in treatment of lower risk prostate cancer Active Surveillance 2005-2009: 10% 2010-2013: 40% Cooperberg et al, JAMA 2015

Effect of 2012 Recommendations Substantial decline in PSA screening Decreased incidence of prostate cancer Increased proportion of high grade disease 4. Increase in metastatic disease at diagnosis

2012 USPSTF Effects Decreased PSA screening rates NHIS Data (Jemal et al, JAMA 2015): 2005 -2008: 36.9% -> 40.6% (+10%) 2010- 2013: 37.8% -> 30.8% (-18%) Sammon, et al ( JAMA 2015): 2010- 2013: Overall 36% ->31% Largest declines: 50-54 yo (-5%) 60-64 yo (-10%)

2012 USPSTF Effects PC Incidence rates by risk group (Barocas, et al) Low-risk: -37% Intermediate-Risk: -28.1 % High-Risk: -23% Prostate Needle Biopsies, 2013-2014 (Banerji, et al) -More likely high risk disease (33% higher RR) -Less likely intermediate risk disease

2012 USPSTF Effects Cancer Grade at Diagnosis 2011 2014 Gleason’s 8 21% 30% (Gaylis) Gleason’s 8-10 9% 19% (Olsson) Gaylis et al, JCO 2016 Olsson et al, J Urol 2017

2012 USPSTF Effects Incidence of Metastatic Disease 2011 2012 2013 Gaylis, et al 5.0% 5.5% 7.7% Hu, et al >75yo: 7.8% 12.0% <75yo: 2.7% 4.0%

2017 Draft Recommendations Clinician inform men ages 55-69 about benefits/harms of PSA-based screening Decision to be screened for prostate CA should be individual one Individualized decision-making w clinician to understand potential risk and benefits and incorporate patient’s own values and preferences Recommend against PSA screening for men 70 years and older

Shortcomings of 2017 Draft No recommendations for: High Risk groups- African-American, Family Hx Screening Intervals Average Risk Men, ages 40-54 Healthy men > 70 yo