Update on Prostate Cancer: Screening, Diagnosis, and Treatment Making Sense of the Noise and Directions Forward

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1 Update on Prostate Cancer: Screening, Diagnosis, and Treatment Making Sense of the Noise and Directions Forward 33 rd Annual Internal Medicine Update December 5, 2015 Ryan C. Hedgepeth, MD, MS Chief of Urological Services, OPG 1

2

3 Screening for prostate cancer Rectal exam More common in advanced disease PSA test PSA available for two decades Sensitive and specific but not perfect Detects cancer earlier than rectal exam or symptoms

4 4 SEER: PSA and Prostate Cancer Deaths

5

6 6 Screening impact takes a long time

7 Prostate Cancer Over-detection Of all screen-detected cancers, an estimated 10-56% would not have become apparent or caused symptoms in the patients lifetimes, and the lead time for diagnosis is estimated at 5-12 years.

8 Compared to observation, prostatectomy did not significantly improve overall or cancer specific survival over a 12-year period (PSA era) in localized low-risk prostate cancer

9 Controversy of PSA screening Benefit: Apparent reduction in prostate cancer mortality Risks: Over-diagnosis of low-risk cancers (2/3 men) Treatment-related morbidity and mortality (9/10 men elect early definitive treatment) D USPSTF recommendations on PSA screening: Cooperberg MR et al. J Clin Oncol. 2010; 28: Welch HG at al. J NCI 2009; 101: Thompson IM et al. JAMA 2010; 304::

10 Current PSA Screening Guidelines ACS Start At 40/45/50 AUA 40/55 69 NCCN Start at 40 Fractionated after by PSA USPSTF None 10

11 11 Current PSA Screening Guidelines

12 Recent decline in prostate cancer incidence in the US, by age, stage, and Gleason score Cancer Medicine 2 DEC 2015 DOI: /cam4.549

13 Did USPSTF lead to changes in biopsy rates or cancer detection? University of Toronto - proponents of surveillance Referrals and prostate biopsy from 2008 to ,408 biopsies performed 1,601 (47.0%) Prostate cancers detected Low risk = 563 (16.5%) Intermediate / High risk = 914 (27%) Monthly Median # of: Biopsies Decreased 58 to 36 (p=0.003) Patients for 1 st biopsy Decreased 43 to 24 (p=0.03) Low risk Decreased 9 to 6 (p=0.012) Intermediate / High Risk!!! Decreased 18 to 10 (p<0.001) Bhindi, B. et al. J Urol May;193(5):

14 Did the USPSTF Recommendation lead to smarter screening practices? National Health Interview Survey: PSA-based screening from 2010 to 2013 Age 40 to 49: No change (13% to 11% p = 0.4) 50 to 59: Declined (33% to 25% p <.01) 60 to 74 Declined (51% to 44% p <.01) 75 & older Declined (44% to 37% p =.03) Did this help prevent unnecessary screening in men at high risk of dying in next 10 years? A large percentage of men were screened despite high risk of 9-year mortality approximately 1/3 older than 75 Approximately 1.4 million men age 65 years or older with a high risk (> 52%) of 9-year mortality were screened in

15 Patient Approach to USPSTF Recs Does exposure to USPSTF recommendation and controversy on treatment of prostate cancer: 1. Predict treatment decisional conflict? 2. Affect treatment choice? 3. Increase regret about PSA testing? Accurate knowledge uncommon (19%) Attitudes toward the recommendation were negative Majority (87%) remained highly supportive of annual PSA testing in men 50. Orom, H. Psychooncology Sep;24(9):

16 Patient Approach to USPSTF Recs Does exposure to USPSTF recommendation and controversy on treatment of prostate cancer: 1. Predict treatment decisional conflict? 2. Affect treatment choice? No No 3. Increase regret about PSA testing? No Orom, H. Psychooncology Sep;24(9):

17 Does PSA Screening Reduce Prostate Cancer Mortality? PLCO: No ERSPC: Yes The difference in the relative risk for mortality has stabilized in favor of screening; 0.85 at 9 years, 0.78 at 11 years, and 0.79 at 13 years

18 Does PSA testing reduce mortality? Over 14 years PSA test Increased the # of cancers detected by 50% BUT Reduced the risk of dying of prostate cancer by 44% in all men and 56% in screened men. The number needed to screen to prevent one death was

19 Treatment Regret in Prostate Cancer Associated with: Androgen-deprivation therapy Urinary bother Satisfaction with understanding potential treatment side effects Effect on the spousal relationship 19

20 Criticism of USPSTF Recommendation European randomized trial now shows significant survival advantage from 9 years on Inappropriate inclusion of very different trials in meta-analysis Lack of appreciation for the strong relationship between PSA and prostate cancer mortality Inadequate consideration of time-to-event (long delay between elevated PSA and death from prostate cancer) Overall mortality is not an appropriate endpoint Mortality risk of surgery exaggerated (0.5%) Vickers AJ, Lilja H. Time for another rethink on prostate cancer screening. Nat Rev Clin Oncol. 2011; 9:7-8.

21 Does the USPSTF Recommendation Do What it Intended to Do? Reduces incidence of prostate cancer? Across full spectrum of disease Temporary Does not change inappropriate screening Does not address overtreatment Reduces referrals and biopsies Decreased detection of Low, Intermediate, and High Risk Prostate cancers Downstream impact on mortality predicted to rise 21

22 If not then what doe the USPSTF Recommendation do? Identifies shortcomings in prostate cancer: Detection Practice patterns Treatment Led to increased awareness of Spectrum of disease Importance screening guidelines Need for better prognostic measures 22

23 What happens when popular option suddenly is not popular? 23

24 Newer PSA screening Tests 4KScore Blood test Patient specific probability of intermediate/high risk Measures total PSA, free PSA, intact PSA & hk2 Algorithm provides % probability of aggressive cancer Progensa PCA3 Urine test Detects overexpression of gene PCA3 Specific to prostate cancer Used to identify need for second biopsy Studies to look at use as screening tool 24

25 The real problem Finding more prostate cancer Finding aggressive prostate cancer

26 What type of prostate cancer?

27 Current process: Ultrasound Guided Prostate Biopsy

28 So what s the problem in detecting prostate cancer with ultrasound? Biopsy blind to the tumor(s) location Prostate cancer is the only solid-organ tumor diagnosed without image guidance in the hopes of accidentally hitting the tumor

29 Trans Rectal Ultrasound (TRUS) Wein et. al. Campbell-Walsh Urology. 9th ed. 2007:Philadephia, PA

30 Why not tumor directed biopsies? Standard of care for all other solid tumors such as breast, liver, etc. All requires imaging/seeing the tumor Problem with prostate cancer is ultrasound does not reliably identify tumors within the prostate

31 3T MRI of the prostate High resolution imaging of the prostate

32 Multiple ways to see tumors T2W DWI-ADC DCE-MRI MRS

33 Why fuse MRI and Ultrasound? MRI TRUS Temporal resolution Spatial resolution Sensitivity/Specificity Cost effective Temporal resolution Spatial resolution Sensitivity/Specificity Cost effective

34 MRI Ultrasound Fusion Biopsy UroNav EM Field Generator TRUS Probe Ultrasound UroNav Workspot UroNav EM Sensor

35 Fusion Biopsy setup

36 In real time

37 Advantages of Fusion Prostate Biopsy Office-based procedure Minimal additional patient discomfort for significant additional diagnostic yield Physicians do what they are best at: Diagnostic radiologist interprets prostate MRI Urologist performs prostate biopsy

38 1,003 patients Targeted fusion biopsy diagnosed: 30% more high-risk cancers 17% fewer low-risk cancers JAMA Jan 27;313(4):390-7

39 Predicting Prostate Cancer Risk Statistical Review of Clinicopathologic Parameters Nomograms Neural Networks Better performance in pre and postoperative prognostic prediction than the opinions of expert clinicians because based on patient volumes Fall short predicting at the individual level who ultimately fail after initial treatment 39

40 Complicated fixes benefit groups but not necessarily individuals 40

41 Predicting Prostate Cancer Behavior with Gene Markers Prolaris: Measures tumor cell growth in + prostate biopsy 46-gene expression signature = cell cycle RNA Low expression associated with low risk progression High expression associated with high risk progression ConfirmMDX Used in negative prostate biopsy Genes associated with prostate cancer Helps predict who needs additional biopsies and who does not 41

42 42 How big is your patient s risk?

43 Can Prostate MRI & Fusion Biopsy help robotic surgery outcomes? Novakovic, K and Pinto, P. CANCER: Principles and Practice of Oncology, 8th ed.

44 Prostate cancer localization: Correlation of MRI, biopsy and pathology

45 Patient selection: Pre-op risk stratification and surgical planning PSA Gleason score Prostate cancer burden Assess stage and planning: Extracapsular extension Seminal vesicle invasion Raskolnikov D, George AK et al. The role of MR image-guided biopsy in stratifiying men at risk for ECE at RP. J Urol 2014; in press Raskolnikov D, George AK et al. MRI and image-guided biopsy to detect SVI by Pca. J Endourol; 28:1283-9

46 Prostate MRI & Fusion Biopsy Fusion biopsy is an innovation in prostate cancer diagnosis and decision making: Improves detection of aggressive cancers Allows for better risk assessment Prostate 3T MRI Likely improves our operative approach and outcomes for robotic prostate surgery

47 47 Update: Prostate Cancer Screening

48 Update: Prostate Cancer Screening There is a mortality benefit to PSA screening USPSTF Recommendation is flawed but has pushed the focus of the disease appropriately Innovations in screening algorithms and gene tests will continue to improve screening accuracy 48

49 Update: Prostate Cancer Detection Innovations in imaging allow us to see potential tumors more clearly MRI Ultrasound Fusion biopsy delivers targeted prostate biopsies with improved detection Gene testing may further stratify prostate cancer risk 49

50 Update: Prostate Cancer Treatment Robotic Prostatectomy continues to show improved outcomes over open prostatectomy Active Surveillance has become an acceptable treatment option for low risk prostate cancer Prostate MRI and Fusion biopsy increase our ability to accurately categorize tumors for those who choose active surveillance HIFU approved in limited situations 50

51 Seeing in new ways

52 Thank You

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