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Preventative Care and Monitoring for Prostate Disease Joshua Broghammer, MD FACS Assistant Professor, Dept of Urology University of Kansas Medical Center
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Disclosures I am not a urologic oncologist Reconstructive urologist Inherent bias against over treatment
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Objectives Incidence of prostate cancer Screening guidelines Screening controversies
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Incidence of Prostate Cancer 2010 1 – 196,038 men diagnosed with PCA – 28,560 died of PCA Excluding skin cancer, most common cancer among men Second leading cancer killer in men 1 CDC website http://www.cdc.gov/cancer/prostate/statistics/
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Prostate Cancer Since 1992, an annual decline in prostate cancer mortality of 4% per year has been observed – Compared with decrease in breast cancer mortality of approximately 2.7%, and colorectal of 4.7% (since 2002), and lung of 2%
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Figure 4. Trends in age-standardized death rates (log scale) for major cancers by age, 1970–2006. Jemal A, Ward E, Thun M (2010) Declining Death Rates Reflect Progress against Cancer. PLoS ONE 5(3): e9584. doi:10.1371/journal.pone.0009584 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0009584
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Prostate Cancer Screening
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Screening-Digital Rectal Exam Detects 25% of cancers we detect today Abnormal in 6-15% of men May be the only sign of aggressive cancer 2 2. Okotie et al., Urology. 2007 Dec;70(6):1117-20.
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Prostate Anatomy http://besthealth.bmj.com
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Tropicana
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PSA Prostate specific antigen Serine Protease (kallikrein like) – Semenogelin I and II Normal component of ejaculate FDA approved WITH DRE – Widespread use in 1988
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Factors Affecting PSA Level-Size Matters
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Other Factors UTI Prostate surgery Other instrumentation (foley, etc) Prostate inflammation – Do not treat with antibiotics and repeat – Consider rescreen in 3 months
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Non-factors Sexual intercourse Digital rectal examination
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Results of Cost Analysis of Screening Cost per InterventionQALY Gained Liver transplantation$237,000 Screening mammography (< age 50)$232,000 Worst case—CaP Screening$145,600 CABG—2 vessel/angina$106,000 Captopril for hypertension$ 82,600 Hydrochlorathiazide for hypertension$ 23,500 Best case—CaP Screening$ 8,700 Stop smoking MD message$ 1,300 QALY=quality-adjusted life years; CaP=prostate cancer; CABG=coronary artery bypass graft Thompson IM, Optenberg SA. Oncology (Huntingt). 1995;9:141-145.
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Screening PSA 0-4 ng/mL classically was the normal range – Some historical evidence supports lowering limit to 0-2.5 Estimated that this would double the number of men age 40-69 with an abnormal result. 3 PSA velocity – Defined as >.75ng/ml year Age specific PSA AgeRecommended Reference (years)Range for Serum PSA (ng/mL) 40–49 0.0–2.5 50–59 0.0–3.5 60–69 0.0–4.5 70–79 0.0–6.5 3. Smith DS et al,. J Urol. 1998 Nov;160(5):1734-8.
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Screening PSA density- PSA/volume of prostate – 0.15 ng/mL/cm3 – Prostate cancer cells produce 10x more PSA Free PSA – Ratio of free to total PSA is reduced in prostate cancer – 25%
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Screening Controversies Economic benefits – How much screening is needed to save 1 life? 503 to save one life (updated from ERSPC trial) Quality of Life – Do risks outweigh benefits Risks associated with the test Loeb S et al., J Clin Oncol. 2011 Feb 1;29(4):464-7
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Screening Pros 90% of prostate cancers detected are localized to the prostate (potentially curable) PSA of 4.0 ng/ml has good sensitivity – Detects over 90% of aggressive prostate cancers – 56% of non-aggressive cancers
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Screening Cons Screening tests must satisfy the following: – Detect curable disease – Provide survival advantage – Treatment options which work Evidence is lacking to support a survival advantage, despite mortality decrease
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Risk of a Biopsy Hospitalization rates of 0.6-4.1% – 0.3% death rate 30 days after (70% lower than aged matched controls) Era of quinolone resistance Ecoli-15% resistance rate in community High risk if your patient has gotten abx in 1 year Nam RK et al. J Urol 2010
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PLCO Cancer Screening Trial Effects of cancer screening on men 55-74 – Excluded if PSA screening in last 3 years Screening completed 2006 Data collection until 2015 76,685 enrolled – Intervention arm (38,340) Annual PSA x 6 years, DRE x 4 years – Control arm (38,345) Usual care-including opportunistic screening
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PLCO 2012 Results Follow up – 92% at 10 years – 57% at 13 years 4250 vs. 3815 diagnosed with PCA – 12% increase in intervention arm Mortality rates from PCA – 3.7 vs. 3.4 per 10K person years (no difference) Andriole GL et al, J Natl Cancer Inst. 2012 Jan 18;104(2):125-32.
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PLCO Controversy Control arm had many men screened PSA cutoff of 4.0 may be too high Selection bias-eligible men may be excluded due to prior screening
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European Randomized Study of Screening for Prostate Cancer Trial Effects of PCA screening on those 50-74 182,000 enrolled – Intervention arm Screening 1 every 4 years – Control Arm No screening PSA cutoff was 3.0 ng/mL Primary outcome-death from prostate cancer Schroder FH et al., N Engl J Med. 2009 Mar 26;360(13):1320-8
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ERSPC Results Incidence of PCA – 8.2% vs. 4.8% Rate ratio for death from PCA 0.80 PSA reduced death rate by 20%, but high over diagnosis rate – 1410 needed to screened, 48 needed to treat at 9 yrs – 503 needed to screened, 18 needed to treat at 12 yrs
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ERSPC Controversy Shorter follow up Modest benefit in screening Several different countries (7 centers) – Sweden and Netherlands significant PCA mortality – Other five centers showed no difference
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To Screen or Not to Screen Need to treat 18-48 men to save a life – What if you’re “that guy” Many studies have significant flaws – Cross over of non-screened control groups Quality of life is an important factor not considered – Treatment – Death of PCA
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Screening Guidelines No screening – US Preventative Services Task Force (Grade D) Chairman was a pediatrician – American Academy of Family Practice Selected screening – American Urological Association – American Cancer Society – National Cancer Institute – American College of Physicians
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AUA Guidelines No PSA Screening <40 No routine screening in average risk age 40-55 Individualized screening for high risk or AA <55 55-69: Shared decision making process – Screening interval of 2 years or more No screening in men 70+ with life expectancy of <10-15 years.
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Urinary Symptoms-LUTS Obstructive: – Decreased force – Hesitancy – Intermittency – Incomplete emptying Irritative: – Frequency – Urgency
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Urinary Symptoms Many things can be a cause Including prostate cancer Talk to your patients
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Screening Guidelines No Organization Supports Annual PSA Screenings in Average Risk Males
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Where did we go wrong? Dialing down PSA Screening everyone Lack of leadership Inherent biases
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Treatment Biases 1.Cure cancer 2.Prevent incontinence 3.Prevent erectile dysfunction
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Treatment Modalities Watchful waiting Active Surveillance Seed Implants External radiation Radical Prostatectomy
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Watchful Waiting Repeated PSA testing Intervention at a predetermined PSA level No real set guidelines Doesn’t sit well with patients
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Active Surveillance T1 disease (biopsy +, negative on DRE) Gleason 6 (low grade disease) ≤ 2 out of 6+ cores positive PSA <10 No cores with >50% involvement
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Active Surveillance Annual repeat biopsy – Combats sampling error Annual PSA – Doubling time of <2 years Consideration for MRI – Evaluate for missed tumors
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Prostate Cancer Prevention PCPT-Prostate cancer prevention trial – Finasteride (Proscar) – 10% reduction in prostate cancer 10.5% finasteride group vs 14.9% in placebo – Increase in high grade prostate cancer 6.4% finasteride group vs 5.1% in placebo Not FDA approved for the prevention of PCA
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Prostate Cancer Prevention SELECT-Selenium and Vitamin E Cancer Prevetion Trial Alone and in combination Selenium- Trend toward but not significant for DM Vitamin E-17% more cancers – 11 per 1000 men
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Conclusions
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PSA testing should exist in some form. Informed decision. Continued screening for high risk men.
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Questions? 44
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