Should A PSA threshold of 1.5 ng/ml be the threshold for further diagnostic tests?

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Sharon Scott
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1 Should A PSA threshold of 1.5 ng/ml be the threshold for further diagnostic tests? Hanan Goldberg, MD Princess Margaret Cancer Centre, UHN, Sunnybrook Health science Centre, University of Toronto, Toronto, Canada

2 Financial and Other Disclosures I have the following financial interests or relationships to disclose: No financial relationships Disclosure code N 2

3 Dare We Go Back to the Pre-PSA Era? With the introduction of PSA testing, death from prostate cancer was reduced by 20%, whereas metastatic disease was reduced by nearly half Welch, nejm ;18. Gomella, LG Celebrating the Death of PSA screening CJU December 2011

4 Message from USPSTF and Canadian Task Force on Preventive Health Care No recommendation was given for men younger than 55.

5 Prostate Cancer Clinical Needs 1. Screening: Primary Care Physicians (PCPs) need a simple message 2. Early Detection: Identify patients with clinically significant PCa earlier 3. Reduce unnecessary repeat prostate biopsies 4. Enhance risk stratification: Surveillance vs. Interventional Therapy

6 Fox Hunt Whom to Screen, Bx, ReBx, and to Treat 6

7 2010

10 What do the Guidelines say?

11 2013 AUA guidelines

12 AUA Screening Guidelines

14 EAU Screening Guidelines

15 EAU Guidelines PSA levels Table demonstrates the occurrence of GS 7 PC at low PSA levels, precluding an optimal PSA threshold for detecting nonpalpable but clinically significant PC.

17 NCCN Screening Guidelines

21 In patients >55 - >30% of men have PSA > 1.5 ng/ml In patients >60 - >40% of men have PSA >1.5 ng/ml Crawford ED et al. An Approach Using PSA Levels of 1.5 ng/ml as the Cutoff for Prostate Cancer Screening in Primary Care. Urology Oct;96: doi: /j.urology Epub 2016 Jul 19.

22 What PSA cutoff should we use in young men under 50?

23 J. Urol 2010

25 PSA Cutoff of 1.5 ng/ml in Young Men Lilja et al. found that a single PSA measured > 1.5 ng/ml in men between years was highly correlated with any cancer (20%), palpable disease (15%), and advanced cancer (5%). [1] Similarly, Vickers et al. showed that men with a PSA in the highest 10th grouping (i.e., 1.6 ng/ ml or greater) at age contributed to nearly half of all PC deaths over the next years. [2] [1] Lilja H, Cronin AM, Dahlin A, et al. Prediction of significant prostate cancer diagnosed 20 to 30 years later with a single measure of prostate-specific antigen at or before age 50. Cancer. 2011;117: [2] Vickers AJ, Ulmert D, Sjoberg DD, et al. Strategy for detection of prostate cancer based on relation between prostate specific antigen at age and long term risk of metastasis: case-control study. BMJ. 2013;346:f2023.

27 METHODS A local institutional prostate biopsy database was queried for all patients <50 who were biopsied in the last 2 decades Patients were analyzed according to their specific PSA values Overall 199 patients were analyzed

28 PATIENT BIOPSY RESULTS Diagnosis of Cancer, n (%) Disease worse than Epstein Criteria, n (%) PSA (<=1) 4 (10.8%) PSA (1-1.5) PSA (1.5-2) PSA (2-2.5) Total p Value 8 (21.6%) 15 (40.5%) 10 (27.1%) 37 (19.2%) (50%) 1 (12.5%) 9 (60%) 7 (70%) 19 (51.4%) 0.083

29 100.0% 92.9% Biopsy Results 80.0% 78.9% 73.7% 79.2% 81.4% 60.0% 40.0% 20.0% 0.0% 21.1% 17.5% 14.6% 14.6% 7.1% 0.0% 3.50% 5.3% 4.2% 2.1% 0.0% 0.0% 0.0% 2.5% 1.5% PSA <=1 PSA (1-1.5) PSA (1.5-2) PSA (2-2.5) Total No cancer Gleason 6 Gleason 7 Gleason 8-10

30 RESULTS A total of 19.2% of patients were diagnosed with PC Of those diagnosed with PC, 25 (68%) had a PSA>1.5 ng/ml and all men with GS>7 had PSA>1.5 ng/ml. Special attention should be paid to patients with smaller prostates, PSA>1.5 ng/ml, and +ive family history

31 What about men older than 50? And is PSA enough in the current era?

32 Beyond PSA We are at an era where using PSA alone to guide prostate biopsy decisions is for the most part ENDING Tools are needed to provide better risk assessment to detect clinically meaningful cancers Reduce unnecessary biopsies Reduce over-detection of indolent disease

33 PSA Screening in the US Do we really want to add more PSA Improve Patient Selection for Biopsy tests and lower the PSA cutoff? ~20 million PSA tests each year ~5 million men with elevated PSA result Diagnose < 180,000 and 40% are candidates for AS 0.9% rate of diagnosis 1. Aubry W, et al. Am Health Drug Benefits. 2013;6(1): National Cancer Institute website. SEER Cancer Statistics Review (CSR) Available at: seer.cancer.gov. Accessed March 13, 2018.

34 Take Home Messages (we can hopefully all agree ) PC screening most probably saves lives. The USPSTF analysis downplays benefits, overestimates harms, and is based on far too short of a time horizon. Overtreatment is a major public health problem, and we need to fix it. The answers lie in smarter, more personalized screening and better treatment decisions, not in wholesale cessation of screening, or lowering the PSA threshold.

35 Take Home Messages In men <50 with a PSA>1.5 ng/ml (especially +ive family history and + DRE), an aggressive approach with prostate biopsy should be considered In men > 50 the standardized one size fits all PSA cutoff of 1.5 ng/ml can result in overscreening, over-diagnosing, over-treating, adverse effects, and financial costs. Incorporating additional PC biomarkers and prostate mpmri in the personalization of diagnosis is the future

36 Thank you Tel-Aviv Toronto

Screening and Risk Stratification of Men for Prostate Cancer Metastasis and Mortality

Screening and Risk Stratification of Men for Prostate Cancer Metastasis and Mortality Sanoj Punnen, MD, MAS Assistant Professor of Urologic Oncology University of Miami, Miller School of Medicine and Sylvester