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Prostate Cancer Screening in the Post-USPSTF Era PowerPoint Presentation

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Description : This medical presentation on cancer titled "Prostate Cancer Screening in the Post-USPSTF Era" intends to explain the rationale behind prostate cancer screening, the implications of USPSTF recommendations on screening, the current recommendations and options to improve screening, and a proposed algorithm for appropriate screening for prostate cancer.

Tags : Cancer, Prostate Cancer, Screening, USPSTF, recommendations, algorithm, appropriate screening

Published on : May 03, 2021 | Views : 1690 | Downloads : 2

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Slide 1-

Prostate Cancer Screening in the Post-USPSTF Era Alon Z. Weizer, MD, MS Associate Professor of Urology Associate Chair, Surgical Services, Department of Urology, University of Michigan
Slide 2-

Disclosures Summus (eConsult Platform): Advisory Board
Slide 3-

Outline Case presentation US Preventative Services Task Force Recommendations as a Wake-Up Call Goals of Cancer Screening PSA and Prostate Cancer Basics Impact of USPSTF on Screening Improvements to Screening Process/Recommendations
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Learning Objectives Understand the rationale behind prostate cancer screening Understand the implications of USPSTF recommendations on screening Appreciate current recommendations and options to improve screening Learn a proposed algorithm for appropriate screening for prostate cancer
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Case Presentation 54 year old Caucasian man presents to your office for annual health maintenance On review of systems, he reports nocturia x 3 Past medical history: hypertension controlled on lisinopril, mild obesity (BMI 31) Past surgical history: right shoulder surgery, appendectomy as a child Social history: machinist, married, 2 kids in college, quit smoking 10 years ago, minimal alcohol use Medications: lisinopril, ibuprofen as needed Allergies: none
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Case Presentation Physical examination: prostate 50 grams, no nodules but left lobe is larger than the right Urinalysis, CBC, basic metabolic panel: normal Next steps…
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United States Preventative Services Task Force Recommendations US Preventative Services Task Force recommendations: 2008: Against PSA screening for men >75 years October 2011: Draft recommendations against screening in all asymptomatic men May 2012: Final recommendations of Grade D for PSA screening in all asymptomatic men Why: Harms of Screening Outweigh the Benefits
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What was the USPSTF’s Evidence? Screening trials show increased diagnosis without improved overall or CaP-specific mortality Treatment significantly impacts a man’s QOL We have over-treated prostate cancer and likely still do today in several venues The PCa screening trials were completed prior to AS – recent data: up to 50% of men diagnosed with localized prostate cancer go on AS As RALP techniques mature, functional outcomes will continue to improve Politically motivated? Treatment costs $11 billion per year
Slide 9-

American Urologic Association Early Detection of Prostate Cancer 2013 Guidelines No PSA screening in men under 40 No routine screening of men 40-54 Consider family history and African American race Men 55-69 have the greatest benefit from screening Shared decision making based on patients values and preferences Can increase screening interval to every 2 years No routine screening for men 70+ or any man with <10-15 year life expectancy Consider population baseline age-adjusted life expectancy and adjust according to patient comorbidities
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American Cancer Society Guidelines for Prostate Cancer Early Detection Main emphasis: discuss the risks and uncertainties of screening to promote an informed decision: Chance that cancer is diagnosed We don’t know which low-risk cancers progress and pose a threat to a patient’s health Diagnosis could compel the patient to undergo treatment that could ultimately be unnecessary Treatments come with significant risks to quality of life (e.g. urinary incontinence, urinary and bowel symptoms, worsening erectile function)
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Who’s Right When it Comes to Screening? Principles of Screening: Disease should have a high incidence √ Biological behavior and natural history of the disease should be known √ Test should have high sensitivity, specificity, and positive predictive value ? Test should be rapid, inexpensive, noninvasive, and acceptable to patients √ Acceptable and efficacious method of treatment must exist for patients diagnosed with disease √ Screening should lower the disease-specific morbidity and increase survival ?
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Examining the Evidence Understanding PSA Prostate Cancer Incidence and Mortality over time Randomized Controlled Trials of PSA Screening
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PSA Facts Discovered in 1970 Most widely used oncologic biomarker 3/4 men over 50 have had a PSA Member of the human kallikrein family of glycoproteins
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PSA Facts Produced by the glandular epithelium of the prostate Trace amounts in salivary, pancreatic and breast tissue Found in semen, urine and blood Serine protease that liquefies semen to improve sperm mobility Found in 3 forms in serum: Bound to α-1-Antichymotrypsin Bound to α-2-Macroglobulin Free PSA
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PSA is NOT Perfect Poor sensitivity (35–70%), specificity (60–90%) for prostate cancer Sensitivity of biopsy in screened is 60-80% at best The traditional PSA cut-off of 4.0 is no longer an absolute indication for biopsy Other factors that affect PSA: Infection/Inflammation/Instrumentation Urinary retention Ejaculation/Vigorous massage Advanced age/Benign enlargement
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Prostate Cancer Facts (SEER) Incidence compared to other common cancers
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Prostate Cancer Incidence over Time
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Prostate Cancer Mortality over Time
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The screening studies European Randomized Study of Screening for Prostate Cancer (Europe) Goteborg Study (Sweden) Prostate, Lung, Colon and Ovarian Cancer Screening trial (U.S.)
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ERSPC: “The European study” Random assignment of men between 50 and 74 in 7 European countries 83,000 in the screened group; 99,000 in the control PSA on average once every 4 years in screened cohort During the median follow up of 11 years, PCa diagnosed in 9.6% of the screened group and 6.0% of controls Schröder FH, NEJM 2012
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ERSPC findings 2012 Screened group was 29% less likely to die from CAP 1055 men would need to be screened and 37 cases of prostate cancer treated to prevent 1 death
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Issues with this Study Positive PSA defined as 3.0 ng/ml in most centers 6-core biopsy used: prostate cancer diagnosis is up to 20% higher with an extended biopsy scheme (10-18 cores) Localized prostate cancer more common in the screened group A definite benefit of avoiding metastatic disease
Slide 23-

Goteborg Study F/U 14 years, decrease risk of death 40% 227 screened, 12 dx to prevent 1 death
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PLCO: “The US trial” 38,000 men each randomly assigned to annual screening or “usual care” Compliance rates for PSA and DRE were 85% and 86%, respectively Usual care included up to 52% getting annual PSA and 46% getting yearly DRE Follow up was for 7 to 10 years Andriole GL, NEJM 2009; 360:1310-1319
Slide 25-

PLCO results 2009 116 vs. 95 incident cases per 10,000 PY in S vs. C 2.0 vs. 1.7 deaths per 10,000 PY in S vs. C
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Issues with this Study High rate of screening in the control group – diluted results Follow up of 7 to 10 years not long enough to realize a mortality advantage from screening Using an absolute value of 4.0 ng/ml as a “positive” PSA may lead to under-diagnosis 18% fewer Gleason 8-10 prostate cancers in the screening group
Slide 27-

Where do we go from here? Utilizing PSA better New Biomarkers that can aid in selection for biopsy Prostate MRI/Fusion Biopsy New Genomic testing helps better define risk Quality Collaboratives Improve Outcomes
Slide 28-

Improving Specificity of PSA Repeat PSA before reacting PSA Density ≥ 0.15 ng/mL/cm3 associated with CaP PSA velocity A rate of change > 0.75 ng/mL/yr (4 < PSA < 10) A rate of change > 0.35 ng/ml/yr (PSA < 2.5) Rates > 2 ng/mL/year have been associated with a quicker time to death from recurrent disease Percent free PSA < 10% more likely CaP > 25% more likely BPH Age-Specific Thresholds
Slide 29-

Biomarkers
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Developed an algorithm to combine serum PSA and urine TMPRSS2:ERG fusion and PCA3 to predict prostate cancer on subsequent biopsy Improved cancer prediction (AUC=0.88; specificity 90%; sensitivity 80%)
Slide 31-

MiPS Test Michigan Prostate Score PCA3 and TMPRSS2:ERG are urine test collected after a prostate exam Another piece of data to help determine if a patient needs a prostate biopsy Example of a MIPS Test Summary Report Serum PSA: 7.26 ng/ml (Provided by client) PCA3 Score: 26 TMPRSS2:ERG Score: 9 MiPS Prostate Cancer Risk: 50% (95% CI 46-55% ) MiPS High Grade Prostate Cancer Risk: 28% (95% CI 24-32%)
Slide 32-

Other Biomarkers/Tests Oncology, Crawford et al, 2014
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Imaging
Slide 34-

Multi-parametric Prostate MRI Technique and sequences are crucial – 3 phases obtained T2: peripheral zone exhibits high signal intensity Peripheral zone cancers have low T2 signal intensity – the lower the intensity the higher grade the disease Cancer more difficult to discern in the transition zone due to signal heterogeneity in this region Diffusion weighted MR measures random motion of water molecules – DWI can help identify high-risk disease Dynamic contrast enhanced (gadolinium) MR allows evaluation of contrast kinetics – cancer enhances quickly, more intensely and with a faster washout MP-MRI sensitivity is 80% for detecting 0.2cm3 disease ≥ Gleason 4+3 or 0.5cm3 Gleason 3+4.
Slide 35-

170 patients with negative biopsy but persistent suspicion of prostate cancer Blinded standard systematic prostate biopsy performed Receiver Operating Characteristic (ROC) analysis showed that MP-MRI contributed most to the prediction model (AUC 0.936) MP-MRI only significant independent predictor of prostate cancer diagnosis Can a MP-MRI without lesion negate the need for repeat prostate biopsy?
Slide 36-

Prostate Biopsy
Slide 37-

Prostate Biopsy > 1.2 million prostate biopsies are performed yearly in the US Elevated PSA most frequently triggers biopsy 30% of men referred for biopsy are diagnosed with prostate cancer Relies on random sampling
Slide 38-

Shortcomings of Standard Systematic Prostate Biopsy False-negative rate Incorrect risk stratification (up to 45%) Detection of clinically insignificant disease Need for repeat biopsy Disease overtreatment Increasing the core number (saturation or repeat biopsy) does not significantly reduce the risk of under sampling and incorrect risk stratification More biopsy episodes increases the risk of detecting indolent cancers Goal: Detect high-grade disease while avoiding low risk disease
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Slide 40-

Types of MRI-Guided Prostate Biopsies Cognitive In-bore Co-registered fusion biopsy
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Patients with low, intermediate and high suspicion lesions had cancer diagnosed 28%, 67% and 90% of the time Fusion biopsy detected more cancer per core than 12-core biopsy
Slide 42-

153 men with suspicion for PCa underwent 3T MP-MRI 105 had lesions classified as low or mod/high risk Targeted and systematic 12-core biopsy PCa in 72% of high risk and 48% of low risk lesions Mean tumor core length 4.6mm for targeted and 3.7mm for standard biopsy Targeted biopsy diagnosed disease in 14% that were missed on systematic 87% of these were clinically significant Upgraded 24% of clinically insignificant cancers on 12-core biopsy to clinically significant
Slide 43-

195 men with previous negative biopsy with targets on MP-MRI underwent MR/US fusion and 12-core biopsy 37% were found to have cancer 11% had high-grade (Gleason 8+) – 55% of these were missed with standard biopsy 39% were upgraded on fusion biopsy vs standard biopsy
Slide 44-

UroNav Fusion Prostate Biopsy – Our Next Step MP-MRI obtained prior to the biopsy session Radiologist outlines targets and contours of the prostate Live US image is overlaid on MR images and contours are matched Standard TRUS side-fire probe with sensor fixed to handle Electromagnetic sensor (satellite) fixed above probe (GPS) detects position of probe in space Targeted and 12-core biopsies obtained
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Genetic Profiling
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Risk Stratifying We don’t know which low (Gleason 6) or intermediate (3+4 or 4+3) risk disease are a true risk to a patient Trying to go beyond Gleason score alone Ongoing trial looking at a commercially available cancer genetic profiling test (Prolaris) to see if it impacts treatment decisions Measures RNA expression level of cell cycle genes 46 gene expression signature of cell proliferation
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Slide 50-

MUSIC Michigan Urologic Surgery Improvement Collaborative
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Vital statistics MUSIC Participants: 42 practices 225 urologists 4 patient advocates Data Collection: 36 practices More than 13,000 cases in the registry > 13,000 biopsies and 2,600 radical prostatectomies
Slide 52-

Pathways for addressing FQ resistance
Slide 53-

Collaborative-wide Hospitalization Rates n = 65 n = 25 n = 65 n = 25 P = 0.0017
Slide 54-

A statewide infrastructure for measuring and improving functional outcomes after radical prostatectomy Patients Providers Practices Collaborative 54 Patient Reported Outcomes (PRO)
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Patient Trend Report
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Only in Michigan: Prostatectomy Video Review Assessment
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Methods-Incidence Ecological study using SEER cancer registry Data from 2005-2012 N = 446,009 Identified incident cases of local/regional or distant prostate cancer Merged SEER data with CDC data to examine changes in incidence by age Incidence Rations (IR) Compare relative change in incidence between consecutive years for age standardized rates
Slide 59-

Methods-PSA testing National Health Interview Surveys (NHIS) data Nationally representative household cross-sectional sample Collected 2005, 2008, 2010, 2013 N = 18,385 Rate of self-reported PSA testing in past year Screening Rate Ratios (SRR) Age and Race adjusted comparison of relative change in screening between years
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9% 16%
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Similar decline in white and black men Data from single registry (Georgia) showed continued 6% decrease in 2013
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18%
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Slide 64-

Conclusions Population-based incidence and PSA screening decreased significantly in response to USPSTF Decrease in both white and black individuals 33,519 fewer men were diagnosed in 2011 compared to 2012 Alternative reason for decline unlikely Unclear how this decrease affects balance between overdiagnosis/overtreatment and missed opportunity of detecting significant cancers
Slide 65-

28% decrease in incident prostate cancer cases in the year following the USPSTF recommendations using the NCDB database 38% decrease in low risk cancers; 28% in intermediate risk; 23% in high risk Difference-in-differences analysis found significant decrease in PSA screening using NHIS
Slide 66-

How do we improve screening Shared decision making around screening in men 50/55-69 years old Obtain a confirmatory test prior to proceeding with biopsy to help refine risk Obtain MRI to help improve the yield of biopsy Promote active surveillance as front line treatment in appropriate patients Consider use of genomic tests to better define risk
Slide 67-

Treatment Appropriateness Rationale: great concern regarding overtreatment Variation is appropriate when it can be explained by factors that are considered relevant in treatment decisions Variation is inappropriate when based on ethnicity, insurance, choice of doctor, ancillary profit, etc
Slide 68-

Active Surveillance for low risk: practice patterns in Michigan Womble et al, Eur Urol, 2014
Slide 69-

Age and Comorbidity Watchful Waiting (WW) Dx Low or Low/Int Risk PC Initial Treatment Consider AS Our focus RLE<10y RLE>10y What is the question? It is NOT: Treatment vs. No Treatment It is: Initial Treatment vs. Consideration of AS Appropriateness Focus Confirmatory tests for AS
Slide 70-

Panel Key points: AS for GL 6 or low volume Gl 3+4 None of the scenarios assessed by the panel were deemed “inappropriate” for AS All low volume Gleason 6 scenarios were deemed “appropriate” or “highly appropriate” for AS, with minimal disagreement 73% of Intermediate Volume Gleason 6 scenarios were deemed “appropriate” or “highly appropriate” for AS Panel members were more “uncertain” about the appropriateness of AS in high volume Gleason 6 and low volume Gleason 7 patients
Slide 71-

Distribution of Pca patients n = 1,425 n = 533 n = 83 n = 877 52% of MUSIC Pca cases meet the tumor criteria for the scenarios considered by the panel
Slide 72-

Proposed simplified clinical pathway for consideration of AS Low or Low-Int risk PC Standardized education and SDM tool Confirmatory studies AS Score Tx Consider AS Shared Decision Making Stay on AS
Slide 73-

Shared decision making Of course, urologists all do this now and do it very well. We are all well above average. And yet, remarkably, this is not how we are perceived in 2015 “Yet there is alarming evidence to indicate that patients may not be properly informed about their options, particularly expectant management options such as watchful waiting or active surveillance.” Blumenthal-Barby JS, Lee D, and Volk RJ. Toward Ethically Responsible Choice Architecture in Prostate Cancer Treatment Decision-Making. CA CANCER J CLIN 2015
Slide 74-

Shared decision making In 2015, the Movember Foundation reviewed PCa treatment SDM web-based tools and recognized 2 instruments as ideal WiserCare Prostate Personal Patient Profile (“P3P”) In Jan 2016, the MUSIC AS working group reviewed both of these and selected P3P Implementation next challenge!!
Slide 75-

Final Word Case: to screen or not to screen? Getting a PSA for symptoms is not screening While better treatments exist for advanced/metastatic disease, no one has examined QOL/morbidity/cost compared to early treatment Questions?