Time Trends and Variation in the Use of Active Surveillance for Management of Low-risk Prostate Cancer in the US.

Importance: Active surveillance (AS) is endorsed by clinical guidelines as the preferred management strategy for low-risk prostate cancer, but its use in contemporary clinical practice remains incompletely defined. Objective: To characterize trends over time and practice- and practitioner-level variation in the use of AS in a large, national disease registry. Design, Setting, and Participants: This retrospective analysis of a prospective cohort study included men with low-risk prostate cancer, defined as prostate-specific antigen (PSA) less than 10 ng/mL, Gleason grade group 1, and clinical stage T1c or T2a, newly diagnosed between January 1, 2014, and June 1, 2021. Patients were identified in the American Urological Association (AUA) Quality (AQUA) Registry, a large quality reporting registry including data from 1945 urology practitioners at 349 practices across 48 US states and territories, comprising more than 8.5 million unique patients. Data are collected automatically from electronic health record systems at participating practices. Exposures: Exposures of interest included patient age, race, and PSA level, as well as urology practice and individual urology practitioners. Main Outcomes and Measures: The outcome of interest was the use of AS as primary treatment. Treatment was determined through analysis of electronic health record structured and unstructured clinical data and determination of surveillance based on follow-up testing with at least 1 PSA level remaining greater than 1.0 ng/mL. Results: A total of 20 809 patients in AQUA were diagnosed with low-risk prostate cancer and had known primary treatment. The median age was 65 (IQR, 59-70) years; 31 (0.1%) were American Indian or Alaska Native; 148 (0.7%) were Asian or Pacific Islander; 1855 (8.9%) were Black; 8351 (40.1%) were White; 169 (0.8%) were of other race or ethnicity; and 10 255 (49.3%) were missing information on race or ethnicity. Rates of AS increased sharply and consistently from 26.5% in 2014 to 59.6% in 2021. However, use of AS varied from 4.0% to 78.0% at the urology practice level and from 0% to 100% at the practitioner level. On multivariable analysis, year of diagnosis was the variable most strongly associated with AS; age, race, and PSA value at diagnosis were all also associated with odds of surveillance. Conclusions and Relevance: This cohort study of AS rates in the AQUA Registry found that national, community-based rates of AS have increased but remain suboptimal, and wide variation persists across practices and practitioners. Continued progress on this critical quality indicator is essential to minimize overtreatment of low-risk prostate cancer and by extension to improve the benefit-to-harm ratio of national prostate cancer early detection efforts.

Use of Monitoring Tests Among Patients With Localized Prostate Cancer Managed With Observation.

PURPOSE: It is unknown whether compliance with recommended monitoring tests during observation of localized prostate cancer has changed over time. MATERIALS AND METHODS: We performed a retrospective cohort study of Medicare beneficiaries diagnosed with low- or intermediate-risk prostate cancer in 2004-2016 who were initially managed with observation for a minimum of 12 months. The primary objective was to examine rates of PSA testing, prostate biopsy, and prostate MRI. We used multivariable mixed effects Poisson regression to determine whether rates of PSA testing and prostate biopsy increased over time. In addition, we identified clinical, sociodemographic, and provider factors associated with the frequency of monitoring tests during observation. RESULTS: We identified 10,639 patients diagnosed at a median age of 73 (IQR 69-77) years. The median follow-up time was 4.3 (IQR 2.7-6.6) years after diagnosis. Among patients managed without treatment for 5 years, 98% received at ≥1 PSA test, 48.0% ≥1 additional prostate biopsy, and 31.0% ≥1 prostate MRI. Among patients managed with observation for ≥12 months, mixed effects Poisson regression revealed that rates of PSA testing and biopsy increased over time (per calendar year: RR 1.02, 95% CI: 1.02-1.03 and RR 1.10, 95% CI: 1.08-1.11, respectively). Clinical and sociodemographic factors including age, clinical risk, race/ethnicity, census tract poverty, and region were associated with rates of biopsy and PSA testing. CONCLUSIONS: Use of recommended monitoring tests including repeat prostate biopsy remains low among Medicare beneficiaries undergoing observation for low- and intermediate-risk prostate cancer.

Implementing Continuous Quality Improvement in an Integrated Community Urology Practice: Lessons Learned.

OBJECTIVE: To determine the effectiveness of 2 different continuous quality improvement interventions in an integrated community urology practice. We specifically assessed the impact of audited physician feedback on improving physicians' adoption of active surveillance for low-risk prostate cancer (CaP) and adherence to a prostate biopsy time-out intervention. MATERIALS AND METHODS: The electronic medical records of Genesis Healthcare Partners were analyzed between August 24, 2011 and September 30, 2020 to evaluate the performance of 2 quality interventions: audited physician feedback to improve active surveillance adoption in low-risk CaP patients, and audited physician feedback to promote adherence to an electronic medical records embedded prostate biopsy time-out template. Physician and Genesis Healthcare Partners group adherence to each quality initiative was compared before and after each intervention type using ANOVA testing. RESULTS: For active surveillance, we consistently saw an increase in active surveillance adoption for low risk CaP patients in association with continuous audited feedback (P < .001). Adherence to the prostate biopsy time-out template improved when audited feedback was provided (P < .001). CONCLUSION: The implementation of clinical guidelines into routine clinical practice remains challenging and poses an obstacle to the improvement of United States healthcare quality. Continuous quality improvement should be a dynamic process, and in our experience, audited feedback coupled with education is most effective.

Leveraging the Electronic Medical Record Improves Prostate Cancer Clinical Staging in a Community Urology Practice.

INTRODUCTION: Clinical tumor staging is an important component of risk stratification, which is central in assessment and treatment of patients with prostate cancer. We evaluated the potential of an examination based tumor staging template embedded within the electronic medical record to improve consistency and clarity of clinical tumor staging. METHODS: We conducted a retrospective analysis before template implementation (January to March 2017), followed by prospective analysis after implementation (April to August 2017). Physicians were educated on use and importance of the staging template prior to implementation. Assessment of digital rectal examination clarity included confident-explicit (cT stage documented), confident-implicit (stage inexplicit, cT stage interpreted) and unconfident (inability to discern cT stage). Clarity and consistency of tumor staging before and after template implementation were compared using a chi-square test. RESULTS: A total of 573 biopsies were analyzed: 234 before template use (40%) and 339 after (60%). In men at risk for prostate cancer explicit staging increased from 16% to 60% (p <0.001) following implementation of the staging template. Overall staging (explicit plus implicit) increased (from 74% to 92%, p <0.001), while unconfident staging decreased (from 26% to 8%, p <0.001) after implementation. In men with positive biopsies (309) explicit staging increased (from 29% to 64%, p <0.001) and overall staging increased (from 76% to 92%, p <0.001), while unconfident staging decreased (from 24% to 8%, p <0.001). CONCLUSIONS: Accurate prostate cancer clinical staging is important in risk stratification and treatment. We demonstrate the ability of a standardized, electronic medical record embedded, American Joint Committee on Cancer based template to improve the consistency and clarity of clinical staging in prostate cancer.

A Path to Clinical Quality Integration Through a Clinically Integrated Network: The Experience of an Academic Health System and Its Community Affiliates.

INTRODUCTION: Academic medical centers (AMCs) and community physicians seeking to establish a clinically integrated network (CIN) may benefit from a road map to navigate the opportunities and challenges of such an organizational structure. Creating and participating in a CIN requires careful consideration, investment of time, financial resources, alignment of a new quality infrastructure, shared governance, and vision. POTENTIAL BENEFITS, CHALLENGES, AND REGULATORY CONSIDERATIONS: Potential AMC benefits include geographic clinical expansion, the ability to provide care for a broader population of patients, a mechanism to collaborate with regional physician graduates, and an expansion of available teaching sites for trainees. Potential benefits to community practices include propagation of high-value care, enhanced access to evidence-based protocols and priority measures, preparation for value-based reimbursement structures, and connection to an institution that produces future health care practitioners. Challenges to CIN creation include goal alignment, trust between AMC and community partners, acceptance of common quality measures and benchmarks, access to shared data, and local adoption of quality improvement activities. QUALITY AND INFORMATION TECHNOLOGY CONSIDERATIONS: At inception the mission was to create an innovative academic-community alliance delivering high-quality, high-value, personalized care. Defining the clinical quality goals, measurement, governance, and improvement strategy, as well as information technology structure and decision making, are described. FUTURE DIRECTIONS: The network continues to grow and now includes more than 350 physicians, in 16 different specialties across 50 different independent medical practices throughout Southern California. We believe this builds a firm foundation for value-based health care.

Low Penetrance Germline Genetic Testing: Role for Risk Stratification in Prostate Cancer Screening and Examples From Clinical Practice.

Broad-based prostate-specific antigen (PSA) screening has saved lives but at a substantial human and financial cost. One way of mitigating this harm, while maintaining and possibly improving the benefit, is by focusing screening efforts on men at higher risk. With age, race, and family history as the only risk factors, many men lack any reliable data to inform their prostate cancer (PCa) screening decisions. Complexities including history of previous negative biopsies, interpretation of negative and/or equivocal mpMRI findings, and patient comorbidities further compound the already complicated decisions surrounding PCa screening and early detection. The authors present cases that provide real-world examples of how a single nucleotide polymorphism-based test can provide patients and providers with personalized PCa risk assessments and allow for development of improved risk-stratified screening regimens.

Contemporary Management of Incident Prostate Cancer in Large Community Urology Practices in the United States.

OBJECTIVE: To characterize the contemporary management of prostate cancer patients in large community practices. The optimal management of incident prostate cancer has changed in the last decades to include active surveillance for a large number of men. At the same time, many community practices have merged into larger groups. The adoption of evidence-based guidelines is of increasing importance, but poorly understood in this newer practice setting. METHODS: We conducted a retrospective chart review of men ≤75 years old with very low, low, and intermediate risk incident prostate cancer diagnosed between December 1, 2012 and March 31, 2014, in 9 geographically distributed large urology practices. We used descriptive statistics and multivariable regression to assess predictors of primary management choice. RESULTS: 2029 men were in the study cohort. A majority were white (68.7%). Total of 45.7% had intermediate risk, 36.2% low risk, and 17.9% had very low risk disease cancer. Active surveillance (AS) was the initial treatment for 74.7% of men with very low risk disease, 43.5% of men with low risk disease and 10.8% of men with intermediate risk disease. The probability of choosing surgery vs radiation for men with lower and intermediate risk disease was 0.54 (95% confidence interval: 0.42, 0.65) and 0.59 (95% confidence interval: 0.48, 0.69), respectively. CONCLUSION: We found that the initial management of lower risk prostate cancer in large community urology practices largely followed clinical characteristics, widespread adoption of active surveillance, and equal use of surgery and radiation. However, some variation by practice suggested a need for further investigation and continued improvement.

Change in prostate cancer presentation coinciding with USPSTF screening recommendations at a community-based urology practice.

OBJECTIVE: The benefits of prostate-specific antigen (PSA)-based prostate cancer screening are controversial. We sought to determine the change in prostate cancer presentation coinciding with the release of the United States Preventative Services Task Force recommendations against screening in a high-volume community-based urology practice. METHODS: Characteristics of men presenting for an elevated PSA at a community urology practice from August 2011 to August 2015 were queried from a prospectively collected database. A retrospective analysis of presenting PSA, Gleason grade at biopsy, and prostatectomy as well as clinical and pathologic stage was performed. Kruskal-Wallis rank sum and chi-square tests were used for analysis. RESULTS: Referrals for elevated PSA decreased from 933 in year 1 to 816 by year 4 (12.5% decrease) with a concomitant reduction in biopsies performed in newly referred men from 461 to 356 (22.8% decrease, P = 0.02). The proportion of men presenting with PSAs>10 increased from 28.1% to 36.8% (P = 0.009). First-time biopsy-positivity rate increased from 48.4% to 62.4% with a rise in the proportion having Gleason≥7 from 51.6% to 69.7% (P = 0.0001). Of the 578 men who underwent radical prostatectomy, there was a 19.4% increase in Gleason≥7 tumors (P = 0.01). CONCLUSIONS: Our findings demonstrate a decrease in elevated PSA referrals, increase in PSA at the time of referral, decrease in detection of low-risk disease, and increase in detection of intermediate-/high-risk disease in a high-volume, multisite, community-based urology practice, coinciding with the United States Preventative Services Task Force recommendations against PSA screening.

White Paper on MACRA: Past, Present and Future.

INTRODUCTION: The U.S. health care system is undergoing significant change as demands to improve medical quality and reduce health care costs expand. U.S. health care spending accounted for 16.9% of gross domestic product in 2013, the highest amount compared to other developed countries. On April 16, 2015 the U.S. Congress passed a historical piece of bipartisan legislation, the Medicare Access and CHIP (Children's Health Insurance Program) Reauthorization Act (MACRA). We describe the events leading up to the passage of MACRA, review the various components of MACRA and describe how MACRA will likely impact physician practices. We also suggest how best to prepare for compliance with the Centers for Medicare & Medicaid Services (CMS) MACRA final rule with comment period, which was released on October 14, 2016. METHODS: A literature review of the quality measures defined by CMS before the passage of MACRA was performed as well as a review of the current MACRA final rule (Quality Payment Program) and related CMS commentary. An expert panel of health care consultants provided guidance concerning compliance with the final rule. Furthermore, case studies are described as examples to assist the urological community in meeting the expectations of MACRA. RESULTS: The Surgical Care Improvement Project process measures (current quality) for urological surgery are reviewed and their impact on surgical site infections is described. Details of MACRA and its Quality Payment Program framework, the Merit-based Incentive Payment System and Alternative Payment Models, are also described. A detailed understanding of and preparation for the implementation of MACRA will help physicians comply with the regulations which offer future opportunities for better reimbursement. Opportunities to comply with MACRA through Advanced Alternative Payment Models may mitigate the complexity of reporting under the alternate Merit-based Incentive Payment System. The development of bundled payment procedures in urology, similar to the Comprehensive Care for Joint Replacement program in orthopedics, may eventually qualify for Advanced Alternative Payment Model status. CONCLUSIONS: Physicians should be proactive, and lead the effort to improve medical quality and control health care related costs, the primary goals of MACRA. Academic and community urologists should collaborate and define optimal quality measures that are meaningful and relevant to the practice of urology, which is currently being done by the AUA (American Urological Association) Quality Registry program. The specialty of urology would benefit from a concerted effort to develop bundled payment models for a variety of urological procedures and seek CMS recognition as qualifying for Advanced Alternative Payment Models.

Assessment of Evidence-Based Standards in the Treatment of Advanced Prostate Cancer in a Community Practice.

INTRODUCTION: Although the monitoring of patients with advanced prostate cancer is essential to optimize treatment, little is known about adherence to guidelines. In this study we compared testing practices at an integrated urology/radiation oncology group practice with evidence-based guidelines and best practices. METHODS: Electronic medical records up to December 2014 from the integrated urology/radiation oncology group practice were queried to identify patients who received androgen deprivation therapy and in whom advanced disease was staged as androgen deprivation therapy sensitive, subcastration resistant (incompletely defined probable castration resistant prostate cancer) or castration resistant after April 2011 and for 6 months or more. Frequency of prostate specific antigen and testosterone level testing as well as imaging (magnetic resonance imaging, computerized tomography, positron emission tomography/computerized tomography, bone scan or x-ray) was evaluated, and compared to national guidelines and best practices. RESULTS: Overall 346 patients with androgen deprivation therapy sensitive prostate cancer, 90 with subcastration resistant prostate cancer and 102 with castration resistant prostate cancer met the study inclusion criteria. On average, prostate specific antigen was tested every 4.7, 3.7 and 3.3 months for patients with androgen deprivation therapy sensitive disease, subcastration resistant prostate cancer and castration resistant prostate cancer, respectively, compared with the 3 to 12 months and 3 months recommendations of the National Comprehensive Cancer Network and RADAR (Prostate Cancer Radiographic Assessments for Detection of Advanced Recurrence) for patients with androgen deprivation therapy sensitive disease and nonmetastatic castration resistant prostate cancer, respectively. Testosterone levels were assessed within 6 months of classification for 23% and 46% of patients with subcastration resistant prostate cancer and castration resistant prostate cancer, respectively. Finally, 28% and 46% of patients with subcastration resistant prostate cancer and castration resistant prostate cancer, respectively, underwent some type of imaging within 6 months. CONCLUSIONS: This retrospective study of patients receiving androgen deprivation therapy at a particular integrated urology/radiation oncology group practice demonstrated adherence to prostate specific antigen best practices. However, there was some room for improvement in terms of testosterone testing and imaging.

Prostate Biopsy Complications: A Dual Analysis.

OBJECTIVE: To measure prostate needle biopsy (PNB)-associated complications and place of treatment: inpatient hospitalization and outpatient treatment. An electronic medical record (EMR) data query is compared to a patient questionnaire survey. MATERIALS AND METHODS: A total of 2410 patients underwent 2588 biopsies and were evaluated for PNB-associated complications. Two approaches were used: (1) EMR analysis based on International Classification of Diseases, Ninth Revision, and Current Procedural Terminology coding and chart review; and (2) patient-reported questionnaire and chart review validation. Serious complications were defined as any complication leading to a related hospitalization, visit to the emergency department (ED), urgent care (UC), or doctor's office within 30 days of the biopsy. RESULTS: The EMR study revealed 69 (2.67%) serious complications leading to either hospitalization or treatment at an ED, UC, or doctor's office. Thirty serious complications led to hospitalization (1.16%), 14 patients (0.54%) were treated at the ED, 1 was managed at a UC (0.04%), and 24 (0.93%) were treated at the doctor's office. Of the 847 (35.1%) questionnaires considered appropriate for analysis, 36 (4.25%) reported treatment in either the hospital, ED, UC, or doctor's office. Nine patients (1.06%) reported being hospitalized within 30 days of the procedure, whereas 27 patients (3.19%) were treated in an outpatient setting, 8 (0.94%) at the ED, 3 (0.35%) at a UC, and 16 (1.89%) at the doctor's office. CONCLUSION: Our dual analysis study indicates a slightly greater than 1% incidence of hospitalization due to serious complications following PNB. Serious complications appear to be more frequently managed outside the hospital setting (ED, UC, and doctor's office).

Active Surveillance of Prostate Cancer in a Community Practice: How to Measure, Manage, and Improve?

OBJECTIVE: To measure past active surveillance (AS) adoption rates, institute the best practice, and measure the AS adoption rates following implementation. We report our findings over a 3-year period. METHODS: Patient prostate needle biopsy and treatment data from the period August 2011 to August 2014 were retrieved from an integrated electronic medical records (Allscripts) and stored in a Microsoft Access database for analysis. Structured data were queried using the automated software program WizMD and unstructured data were abstracted by manual review. AS adoption was calculated according to four different selection criteria. Between 2013 and 2014, physicians at Genesis Healthcare Partners (GHP) underwent an educational training program on the University of California, San Diego/GHP AS best practice for managing low-risk prostate cancer patients and were provided report cards on their AS adoption and comparative reporting. RESULTS: AS adoption increased for the 3 years of the study. AS adoption for all newly diagnosed patients managed at GHP increased from 12.9% to 14.74%. AS adoption for patients with low-risk prostate cancer (as defined by the National Comprehensive Cancer Network) increased from 31.90% to 58.46% from year 1 to year 3 of the study (P < .001), and AS adoption for the most strict (restrictive) criteria increased from 43.75% to 82.61% (P < .001) after the educational and comparative reporting intervention. CONCLUSION: These data highlight the potential benefit of physician education and comparative reporting to enhance AS adoption. AS adoption rates vary according to selection criteria used for analysis. Carefully selected outcomes from evidence-based guidelines have the potential to enhance medical quality.

Selective estrogen receptor alpha agonist GTx-758 decreases testosterone with reduced side effects of androgen deprivation therapy in men with advanced prostate cancer.

BACKGROUND: A need remains for new therapeutic approaches for men with advanced prostate cancer, particularly earlier in the disease course. OBJECTIVE: To assess the ability of an oral selective estrogen receptor α agonist (GTx-758) to lower testosterone concentrations compared with leuprolide while minimizing estrogen deficiency-related side effects of androgen-deprivation therapy. DESIGN, SETTING, AND PARTICIPANTS: Hormone-naive advanced prostate cancer patients were randomized to oral GTx-758 1000 mg/d, 2000 mg/d, or leuprolide depot. INTERVENTION: GTx-758 and leuprolide. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was the proportion of patients achieving total testosterone ≤ 50 ng/dl by day 60. Secondary end points included serum free testosterone, prostate-specific antigen (PSA), sex hormone-binding globulin, hot flashes, bone turnover markers, and insulin-like growth factor (IGF)-1 levels. RESULTS AND LIMITATIONS: Of 159 randomized patients, leuprolide reduced total testosterone to ≤ 50 ng/dl in a greater proportion of patients than GTx-758 by day 60 (43.4%, 63.6%, and 88.2% of subjects receiving GTx-758 1000 mg [p<0.001], GTx-758 2000 mg [p=0.004], and leuprolide, respectively). GTx-758 reduced free testosterone and PSA earlier and to a greater degree than leuprolide. GTx-758 led to fewer hot flashes, decreases in bone turnover markers, and alterations in IGF-1 compared with leuprolide. A higher incidence of venous thromboembolic events (VTEs) was seen with GTx-758 (4.1%) compared with leuprolide (0.0%). CONCLUSIONS: Although leuprolide reduced total testosterone to ≤ 50 ng/dl in a greater proportion of patients compared with GTx-758, GTx-758 was superior in lowering free testosterone and PSA. GTx-758 reduced estrogen deficiency side effects of hot flashes, bone loss, and insulin resistance but with a higher incidence of VTEs. PATIENT SUMMARY: This paper reports findings that leuprolide lowered total testosterone more than GTx-758 but that GTx-758 lowered free testosterone and prostate-specific antigen more than leuprolide. GTx-758 also reduced estrogen deficiency side effects, albeit at a higher rate of vascular events. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT01615120.