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.

Adherence to First-Line Intravesical Bacillus Calmette-Guérin Therapy in the Context of Guideline Recommendations for US Patients With High-Risk Non-muscle Invasive Bladder Cancer.

Background: Bacillus Calmette-Guérin (BCG) can reduce recurrence and delay progression among patients with high-risk non-muscle invasive bladder cancer (NMIBC), but is associated with a substantial emotional, physical, and social burden. Objectives: This study evaluated the adequacy of first-line intravesical BCG treatment among high-risk NMIBC patients in the United States, including the subgroup with carcinoma in situ (CIS) of the bladder. Methods: Adults with high-risk NMIBC treated with BCG were selected from de-identified MarketScan® Commercial, Medicare, and Medicaid Databases (1/1/2010-2/28/2021). Adequacy of BCG induction and maintenance was evaluated from the first BCG claim until the end of the patient's observation, using a previously published claims-based algorithm (induction: ≥5 instillations within 70 days; induction and maintenance: ≥7 instillations within 274 days of first instillation) and a definition based on the landmark Southwest Oncology Group (SWOG) trial (induction: ≥5 instillations without gaps >7 days; followed by ≥2 instillations at month 3, 6, and every 6 months thereafter). Proportions of patients with adequate BCG induction and maintenance were reported overall and compared between those with and without CIS. Results: Of 5803 high-risk NMIBC patients treated with first-line BCG (mean age, 67.3 years; 20.6% female), 930 (16.0%) had CIS. After first-line BCG, 56.6% received another treatment. Although 86.9% had adequate BCG induction based on the claims-based algorithm (SWOG, 73.6%), only 41.5% had adequate BCG induction and maintenance (SWOG, 1.6%). Similar trends were observed for patients with and without CIS, with higher adherence to guidelines for patients with CIS (adequate induction using claims-based algorithm: 90.3% vs 86.2%; adequate induction and maintenance: 50.8% vs 39.7%, all P < .001). A greater proportion of CIS patients than non-CIS patients had cystectomy (CIS, 14.4%, non-CIS, 8.5%; P < .001) after first-line BCG. Discussion: Among patients with NMIBC treated with first-line intravesical BCG, most received adequate BCG induction but less than half had adequate BCG maintenance. BCG treatment was also inadequate for patients with CIS, with only half of patients receiving adequate BCG maintenance and a higher proportion undergoing cystectomy following first-line BCG. Conclusions: Results emphasize the need for additional treatment options for patients with NMIBC.

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.

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.

Preprinted standardized orders promote venous thromboembolism prophylaxis compared with traditional handwritten orders: an endorsement of standardized evidence-based practice.

The objective was to determine if a standardized process of care--namely, standardized evidence-based medical orders (SEBMOs)--improves physician compliance with venous thromboembolism (VTE) prophylaxis. A total of 61 physicians received information about VTE prophylaxis after introduction of an admission SEBMO. Hospitalists received enhanced presentations about SEBMOs and their value in VTE prevention; specialists did not. Data were analyzed for 2 cohorts of 249 at-risk patients: one cohort was admitted with SEBMOs and the other with handwritten orders. VTE prophylaxis was ordered for 70% (173 of 249) of the SEBMO cohort compared with 22% (55 of 249) of patients whose physicians handwrote orders (relative risk ratio = 2.97; 95% confidence interval = 2.33-3.79; P < .0001). Specialists, who did not receive the enhanced education, were more likely to use handwritten orders and less likely to comply with prophylaxis standards. Standardized orders promote VTE prophylaxis more than handwritten orders. More rigorous education is required to promote compliance with evidence-based standards of medical practice.

Prostate cancer in men using testosterone supplementation.

PURPOSE: Although an association between testosterone supplementation and the development of prostate cancer is unproven, a recent increase in the use of this therapy has reopened the debate about its safety in men at risk for prostate cancer. To increase awareness of this risk, we report on a series of patients in whom clinically significant prostate cancer developed and was presumed to be related to exogenous testosterone use. MATERIALS AND METHODS: The medical records of 6 urology practices were reviewed to identify men undergoing testosterone supplementation for sexual dysfunction or "rejuvenation " who were found to have prostate cancer after initiation of exogenous testosterone supplementation. Cases were analyzed to determine clinical and pathological parameters characterizing the presentation of prostate cancer. RESULTS: A total of 20 men were diagnosed with prostate cancer after initiation of testosterone therapy. Prostate cancer was detected within 2 years of testosterone initiation in 11 men (55%) and from 28 months to 8 years in the remainder. The tumors were of moderate and high grade, being Gleason sum 6, 7 and 8 to 10 in 9 (45%), 6 (30%) and 5 (25%) men, respectively. Median serum prostate specific antigen (PSA) concentration at diagnosis tended to be low at 5.1 ng/ml (range 1.1 to 329.0) and digital rectal examination generally proved more sensitive than PSA assays in detecting the cancer. Patients seen by nonurologist physicians were monitored less often for prostate cancer during testosterone use than those followed by urologists. CONCLUSIONS: Prostate cancer may become clinically apparent within months to a few years after the initiation of testosterone treatment. Digital rectal examination is particularly important in the detection of these cancers. Physicians prescribing testosterone supplementation and patients receiving it should be cognizant of this risk, and serum PSA testing and digital rectal examination should be performed frequently during treatment.