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OVERVIEW

Modern Management of Prostate Cancer With Active Surveillance PROSTATE CANCER SYMPOSIUM NORTHWESTERN UNIVERSITY FEINBERG SCHOOL OF MEDICINE SEPTEMBER 10, 2011.

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OVERVIEW

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  1. Modern Management of Prostate Cancer With Active Surveillance PROSTATE CANCER SYMPOSIUMNORTHWESTERN UNIVERSITY FEINBERG SCHOOL OF MEDICINESEPTEMBER 10, 2011

  2. PROSTATE CANCER SYMPOSIUMNORTHWESTERN UNIVERSITY FEINBERG SCHOOL OF MEDICINESEPTEMBER 10, 2011Kristian R. Novakovic, MD, FACSDivision of UrologyNorthShore University HealthSystem

  3. OVERVIEW • Watchful Waiting Versus Active Surveillance • Active Surveillance: Pros and Cons • Prostate Cancer Over Diagnosis and Over Treatment • Morbidity of Treatment • NorthShore University HealthSystem Active Surveillance Clinical Trial • Clinical Outcomes • Risk Stratification • Pathological Outcomes • Conclusions

  4. WATCHFUL WAITING VERSUS ACTIVE SURVEILLANCE

  5. ACTIVE SURVEILLANCEPROS AND CONS Pros • Screen-detected prostate cancers both over diagnosed and over treated • All prostate cancer treatments associated with significant morbidity Cons • Window of curability lost by disease progression during period of active surveillance • Patient anxiety during active surveillance • Morbidity of repeat biopsies every 12-18 months • Increased difficulty of performing radical prostatectomy following multiple biopsies

  6. PROSTATE CANCER OVER DIAGNOSIS AND OVER TREATMENT

  7. PROSTATE CANCER PREVALENCE AND MORTALITY • Newborn American male has 16% lifetime risk of being diagnosed with prostate cancer – 1 new case every 3 minutes • 1/3 of men over age 60 and 1/2 of men over age 70 have prostate cancer • But lifetime risk of death from prostate cancer is only 3%

  8. Prostate Cancer Screening Trials American Trial: • 76,693 men between 55 and 74 randomized to either annual screening or usual care • After 7-10 years of follow-up, death rate from prostate cancer was very low and did not differ significantly between the two study groups European Trial: • 162,243 men between 55 and 69 randomized to either annual screening or no screening • For first 10 years of follow-up, risk of death from prostate cancer was the same between the two groups, but, after 10 years, there was a 20% decrease in risk of death in the screened group

  9. American and European Prostate Cancer Screening Trials AMERICAN TRIAL EUROPEAN TRIAL Cumulative Hazard Year

  10. European Prostate Cancer Screening Trial • At median follow up of 8 years, estimated 1410 men needed to be screened (NNS) and 48 men needed to be treated (NNT) to prevent 1 prostate cancer death • Extrapolating these data: Loeb, S, et al: 2010 American Association of Genitourinary Surgeons Annual Meeting (not presented)

  11. MORBIDITY OF TREATMENT

  12. Biochemical Recurrence Rates and Recovery of Urinary and Erectile Function at 1 Year Following Radical Prostatectomy Each circle represents a single surgeon, and the size of the circle is proportion to the number of patients treated by that surgeon. Eastham, J.: AAGUS, May, 2010

  13. RANDOMIZED TRIAL OF WATCHFUL WAITING VERSUS RADICAL PROSTATECTOMY • Scandinavian randomized trial of 695 men found absolute risk reduction of 6.1% in prostate cancer deaths at 15 years in men undergoing radical prostatectomy vs watchful waiting • Number needed to treat to prevent 1 prostate cancer death – 15 • Benefit more pronounced in men < 65 years of age • Number needed to treat – 7 • Men in “low risk” group also derived benefit • 4.2% reduction Bill-Axelson, A, et al, Radical prostatectomy versus watchful waiting in early prostate cancer: NEJM 364:18 (1708-1717), 2011.

  14. NORTHSHORE UNIVERSITY HEALTHSYSTEM ACTIVE SURVEILLANCE CLINICAL TRIAL

  15. NORTHSHORE UNIVERSITY HEALTHSYSTEM ACTIVE SURVEILLANCE CLINICAL TRIAL ELIGIBILITY CRITERIA • Age > 60 years • Men meeting the six following clinical and pathologic criteria: • Clinical stage T1c or T2a prostate cancer, verified by a NorthShore University HealthSystem urologist. • Biopsy Gleason Score < 6, with no primary or secondary 4 or 5 tumor pattern; pathology verified by NorthShore University HealthSystem pathologist. • Diagnosis of prostate cancer made on at least a 12 core needle biopsy with < 3 cores positive for cancer. • Maximum tumor length < 50% of any core. • Total tumor volume < 5% of biopsy volume. • Men must undergo a repeat, confirmatory, 12 core ultrasound-guided prostatic needle biopsy by a NorthShore University HealthSystem urologist using 3-dimensional, color Doppler equipment. These confirmatory biopsies will also be reviewed by a NorthShore University HealthSystem pathologist.

  16. NORTHSHORE UNIVERSITY HEALTHSYSTEM ACTIVE SURVEILLANCE CLINICAL TRIAL PROTOCOL SCHEDULE

  17. NORTHSHORE UNIVERSITY HEALTHSYSTEM ACTIVE SURVEILLANCE CLINICAL TRIAL

  18. CLINICAL OUTCOMES

  19. ACTIVE SURVEILLANCECLINICAL OUTCOMES Newcomb, LF: Urology 75:407-413, 2010

  20. RISK STRATIFICATION

  21. RISK STRATIFICATION CUMULATIVE INCIDENCE OF DISEASE PROGRESSION AT INITIAL SURVEILLANCE BIOPSY 376 Patients: Tseng, KS, et al., J Urol 183:1779-1785, May 2010

  22. CUMULATIVE INCIDENCE OF DISEASE PROGRESSION 3 YEARS AFTER INITIAL SURVEILLANCE BIOPSY 376 Patients: PSAD1 = PSA Density defined by Serum PSA/Prostate Weight Tseng, KS, et al., J Urol 183:1779-1785, May 2010

  23. PATHOLOGICAL OUTCOMES

  24. PATHOLOGICAL FINDINGS IN MEN IN WHOM ACTIVE SURVEILLANCE FAILS • 51/470 men (10.9%) underwent radical prostatectomy • Radical prostatectomy slides available for review in 48 of 51 Organ-confined 65% Extracapsular tumor extension 35% Positive surgical margins 15% Seminal vesicle involvement 2% Lymph node involvement 4% Duffield, AS, et al. J Urol 182, 2274-2279, November 2009

  25. PATHOLOGICAL FINDINGS IN MEN IN WHOM ACTIVE SURVEILLANCE FAILS • Mean tumor volume 1.4 cm3 • Most progression occurred 1-2 years after enrollment into active surveillance, suggesting undersampling of more aggressive tumor rather than progression of indolent tumor • All 10 tumors with a dominant tumor nodule > 1 cm 3 were located anteriorly confirming a need for improved imaging. Duffield, AS, et al. J Urol 182, 2274-2279, November 2009

  26. IS ACTIVE SURVEILLANCE – DELAYED RADICAL PROSTATECTOMY ASSOCIATED WITH A HIGHER RISK OF UNFAVORABLE OUTCOMES? Van den Bergh, RCN, et al. Cancer, 116:1281-90, March, 2010

  27. CONCLUSIONS • Active surveillance is different from watchful waiting with strict enrollment criteria and close surveillance • Rationale of active surveillance is to avoid over treatment and morbidity of treatment • Clinical outcomes generally favorable but largely dependant on variable inclusion criteria • Risk stratification possible based on initial and surveillance biopsies, but there is a need for improved imaging and biomarkers to predict and monitor disease progression • Pathological outcomes in men failing active surveillance who undergo radical prostatectomy are similar to men undergoing immediate radical prostatectomy • Quality of life issues and patient personality important considerations in decision of whether or not to enroll in active surveillance

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