Major Complications and Adverse Events Related to Use of SpaceOAR Hydrogel for Prostate Cancer Radiotherapy.

OBJECTIVE: To determine the prevalence and severity of SpaceOAR-related adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We analyzed SpaceOAR-related adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) database from January 2015 to May 2023. For each report, the event type, associated device and patient problems, event description, event timing, and event severity stratified by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE) grading system were recorded. RESULTS: From 2015 to 2022, 206,619 SpaceOAR devices were sold. From January 2015 to May 2023, we identified 981 reports describing 990 SpaceOAR-related adverse events. Malfunctions were the most common event type (N = 626), followed by patient injuries (N = 350) with few reported deaths (N = 5). Device positioning problems were the most frequent device issue (N = 686). Pain was the most reported patient problem (N = 216). Abscesses and fistulas related to the device were each reported in 91 events. A noteworthy portion of relevant adverse events occurred before the initiation of radiation (N = 35, 22.4%), suggesting the device, rather than the radiation, was responsible. In total, 470 (50.2%) and 344 (36.7%) of the adverse events were CTCAE grade 1 and 2, respectively. There were 123 (13.1%) events that were CTCAE grade ≥3. CONCLUSION: We identified multiple reports of SpaceOAR-related adverse events, many of which are more serious than have been reported in clinical trials. While SpaceOAR use is common, suggesting these events are rare, these data highlight the need for continued postmarket surveillance.

Trends, Cost, and Predictors of Local Hemostatics Use in Major Urological Surgery.

INTRODUCTION: The national usage and cost trends associated with hemostatic agents in major urologic procedures remain unknown. This study aims to describe the trends, costs, and predictors of local hemostatic use in major urologic surgeries. METHODS: We utilized the Premier Healthcare Database to analyze 385,261 patient encounters between 2000 and 2020. Our primary objective was to describe the usage patterns of topical hemostatic agents in open and laparoscopic/robotic major urological surgeries. The data from the last 5 years (2015-2020) were used to characterize specific cost trends, and multivariable regression analysis was performed to identify predictors of hemostatic agent use in relation to surgical approach, patient, and hospital characteristics. RESULTS: By 2020, at least 1 topical hemostatic agent was used in 37.3% (95% CI: 35.5-39.1) of laparoscopic/robotic prostatectomies and 30.7% (95% CI: 24.2-37.1) of open prostatectomies; 60.8% (95% CI: 57.6-64.1) of laparoscopic/robotic partial nephrectomies and 55.9% (95% CI: 47.3-64.5) of open partial nephrectomies; 40.7% (95% CI: 36.9-44.3) of laparoscopic/robotic radical nephrectomies and 43.2% (95% CI: 38.8-47.6) of open radical nephrectomies; and 40.52% (95% CI: 35.02-46.02) of open radical cystectomies. For the 2015-2020 cohort, predictors for hemostatic agent use varied by surgery type and included gender, race, surgical approach, insurance coverage, geographical location, urbanicity, and attending volume. The cost of the hemostatic agent accounted for less than 1.6% of the total cost of hospitalization for each procedure. CONCLUSIONS: The use of hemostatic agents in major urologic surgeries has grown over the past 2 decades. For all procedures, the specific cost of using a hemostatic agent constitutes a small fraction of the total hospitalization cost and does not vary significantly between open and laparoscopic/robotic approaches. Some patient, surgeon, and hospital characteristics are highly correlated with their use.

Prostate cancer genetic alterations in Hispanic men.

BACKGROUND: Differences in DNA alterations in prostate cancer among White, Black, and Asian men have been widely described. This is the first description of the frequency of DNA alterations in primary and metastatic prostate cancer samples of self-reported Hispanic men. METHODS: We utilized targeted next-generation sequencing tumor genomic profiles from prostate cancer tissues that underwent clinical sequencing at academic centers (GENIE 11th). We decided to restrict our analysis to the samples from Memorial Sloan Kettering Cancer Center as it was by far the main contributor of Hispanic samples. The numbers of men by self-reported ethnicity and racial categories were analyzed via Fisher's exact test between Hispanic-White versus non-Hispanic White. RESULTS AND LIMITATIONS: Our cohort consisted of 1412 primary and 818 metastatic adenocarcinomas. In primary adenocarcinomas, TMPRSS2 and ERG gene alterations were less common in non-Hispanic White men than Hispanic White (31.86% vs. 51.28%, p = 0.0007, odds ratio [OR] = 0.44 [0.27-0.72] and 25.34% vs. 42.31%, p = 0.002, OR = 0.46 [0.28-0.76]). In metastatic tumors, KRAS and CCNE1 alterations were less prevalent in non-Hispanic White men (1.03% vs. 7.50%, p = 0.014, OR = 0.13 [0.03, 0.78] and 1.29% vs. 10.00%, p = 0.003, OR = 0.12 [0.03, 0.54]). No significant differences were found in actionable alterations and androgen receptor mutations between the groups. Due to the lack of clinical characteristics and genetic ancestry in this dataset, correlation with these could not be explored. CONCLUSION: DNA alteration frequencies in primary and metastatic prostate cancer tumors differ among Hispanic-White and non-Hispanic White men. Notably, we found no significant differences in the prevalence of actionable genetic alterations between the groups, suggesting that a significant number of Hispanic men could benefit from the development of targeted therapies.

Adoption and Outcomes of Holmium Laser Enucleation of the Prostate in the United States.

OBJECTIVE: To investigate the utilization of holmium laser enucleation of the prostate (HoLEP) using a large real-world cohort. We compare the safety, readmission, and retreatment rates of HoLEP to other widely used endoscopic surgical interventions for benign prostatic hyperplasia (BPH) including transurethral resection of the prostate (TURP), photoselective vaporization of the prostate, and prostatic urethral lift. METHODS: Men who underwent endoscopic treatments for BPH from 2000 to 2019 were identified in the Premier Healthcare Database (n = 218,793). We compared the relative proportion of each procedure performed and annual physician volume data to identify trends in adoption and utilization. Readmission and retreatment rates were determined at both 30- and 90-days postoperation. Multivariable logistic regression was used to assess the association between procedure type and outcomes. RESULTS: HoLEP accounted for 3.2% (n = 6967) of all the BPH procedures performed between 2000 and 2019 and increased from 1.1% of the procedures in 2008 to 4% in 2019. Patients undergoing HoLEP had lower odds of 90-days readmission compared to TURP (Odds ratio (OR) 0.87, p = 0.025). HoLEP had similar odds of retreatment compared to TURP at both 1-year (OR 0.96, p = 0.7) and 2-years (OR 0.98, p = 0.9), while patients undergoing photoselective vaporization of the prostate and prostatic urethral lift were more likely to retreat within 2-years (OR 1.20, P < 0.001; OR 1.87, P < 0.001). CONCLUSION: HoLEP is a safe therapy for BPH with lower readmission and comparable retreatment rates to the gold standard TURP. Despite this, the utilization of HoLEP has lagged behind other endoscopic procedures and remains low.

Price transparency of prostate cancer care in the United States: An analysis of pricing and disclosure following the centers for medicare and medicaid mandate.

BACKGROUND: Starting January 1, 2021, Centers for Medicare and Medicaid Services required United States hospitals to publicly disclose prices of their services provided. We analyzed publicly-disclosed prices of prostate cancer-related services. METHODS: All United States hospitals were queried for publicly-disclosed prices of total and free prostate-specific antigen, prostate magnetic resonance imaging, prostate biopsy, radical prostatectomy, and intensity-modulated radiation therapy as of May 2022. Prices were adjusted by regional price parity. Hospitals disclosing prices were compared with non-disclosing hospitals. RESULTS: Of 6013 hospitals, 3840 (64%) disclosed pricing for at least one prostate cancer-related service. Compared to non-disclosing hospitals, disclosing hospitals had higher median gross annual revenue ($318,502,426 vs. $62,930,436, p < 0.001) and were more likely to be non-profit (56% vs. 30%, p < 0.001), academic-affiliated (46% vs. 13%, p < 0.001), and in neighborhoods with low hospital density (68% vs 62%, p < 0.001). Self-pay prices were higher than insurance-negotiated prices for all services (p < 0.001) other than prostate biopsy. The range of pricing was widest for self-pay prostatectomy, with a 32-fold difference from 90th to 10th percentile ($47,445 to $1476). Self-pay prices of total prostate-specific antigen, magnetic resonance imaging, biopsy, intensity-modulated radiation therapy, and prostatectomy were higher at academic vs. non-academic, for-profit vs. non-profit hospitals, and hospitals in the top quartile of gross annual revenue vs. the third and fourth quartiles (p < 0.01). Self-pay prices of prostate biopsy and prostatectomy were higher in urban vs. rural neighborhoods and neighborhoods with high vs. low hospital density (p < 0.001). CONCLUSIONS: Self-pay prices of prostate cancer services were generally higher than insurance-negotiated prices and were higher at for-profit hospitals, academic hospitals, and hospitals in the highest quartile of gross annual revenue. Higher neighborhood hospital density was not associated with higher likelihood of price disclosure nor lower pricing of services, suggesting that local competition does not lead to lower prices and may disincentivize disclosure of prices.

National Adherence to Guidelines for Antimicrobial Prophylaxis for Patients Undergoing Radical Cystectomy.

PURPOSE: The sentinel reference for antibiotic prophylaxis for radical cystectomy with ileal conduit in the AUA Guidelines reports data from 2003-2013 and has not been updated in the interim. Here, we assess adherence to antibiotic prophylaxis guidelines among patients undergoing radical cystectomy with ileal conduit for bladder cancer using a large national database. As a secondary objective, we assess the association between antimicrobial use and postoperative infection during the index admission following cystectomy. MATERIALS AND METHODS: The Premier Healthcare Database was queried for all patients undergoing cystectomy with ileal conduit with diagnosis of bladder cancer between 2015 and 2020. Antibiotics used and the duration of use was determined by charge codes and grouped as guidelines-based or not according to 2019 AUA Guidelines. Association with infectious complications was assessed by logistic mixed effects regression models. RESULTS: Among 6,708 patients undergoing cystectomy with ileal conduit, only 28% (1,843/6,708) were given prophylaxis according to AUA guidelines; 1.8% (121/6,708) of patients received an antifungal and 37% (2,482/6,708) received extended duration prophylaxis beyond postoperative day 1. Patients who received guidelines-based prophylaxis were less likely to be diagnosed with a urinary tract infection (21% vs 24%, P = .04), pyelonephritis (5.1% vs 7.7%, P < .001), bacterial infection (24% vs 27%, P = .03), or pneumonia (12% vs 17%, P < .001). There was no statistically significant difference in clostridium difficile infection between guidelines-based and nonguidelines-based prophylaxis (3.2% vs 3.7%, P = .32). In a multivariable logistic regression adjusting for age, race, insurance, and hospital and provider characteristics, nonguideline antibiotic prophylaxis (OR 1.27 [1.12, 1.43], P < .001) was associated with an increased odds of infectious events, whereas a robotic approach (OR 0.82 [0.73, 0.92], P < .001) was associated with lower odds. CONCLUSIONS: Seventy-three percent of patients fail to receive guideline-based antibiotic prophylaxis when undergoing radical cystectomy with conduit, which was largely driven by extended duration antibiotic use. Despite the shorter duration of antibiotics, we found that guideline-based prophylaxis was associated with a 25% decrease in the odds of infectious complications. While residual confounding is possible, these data support current AUA guidelines and suggest a need for outreach to improve guideline adherence.

Intensity of observation with active surveillance or watchful waiting in men with prostate cancer in the United States.

BACKGROUND: Population-based studies assessing various active surveillance (AS) protocols for prostate cancer, to date, have inferred AS participation by the lack of definitive treatment and use of post-diagnostic testing. This is problematic as evidence suggests that most men do not adhere to AS protocols. We sought to develop a novel method of identifying men on AS or watchful waiting (WW) independent of post-diagnostic testing and aimed to identify possible predictors of follow-up intensity in men on AS/WW. METHODS: A predictive model was developed using SEER watchful waiting data to identify men ≥66 years on AS between 2010-2015, irrespective of post-diagnostic testing, and applied to SEER-Medicare database. AS intensity among different variables including age, prostate-specific antigen (PSA) level, number of total and positive biopsy cores, Charlson comorbidity index, race (Black vs. non-Black), US census region, and county poverty, income, and education levels were compared using multivariable regression analyses for PSA testing, surveillance biopsy, and magnetic resonance imaging (MRI). RESULTS: A total of 2238 men were identified as being on AS. Of which, 81%, 33%, and 10% had a PSA test, surveillance biopsy, and MRI scan within 1-2 years, respectively. On multivariable analyses, Black men were less likely to have a PSA test (adjusted rate ratio [ARR] 0.60, 95% CI: 0.53-0.69), MRI scan (ARR 0.40, 95% CI: 0.24-0.68), and surveillance biopsy (ARR 0.71, 95% CI: 0.55-0.92) than non-Black men. Men within the highest income quintile were more likely to undergo PSA test (ARR 1.16, 95% CI: 1.05-1.27) and MRI scan (ARR 1.60, 95% CI 1.15-2.27) compared to men with the lowest income. CONCLUSIONS: Black men and men with lower incomes on AS underwent less rigorous monitoring. Further study is needed to understand and ameliorate differences in AS rigor stemming from sociodemographic differences.

Race and prostate cancer: genomic landscape.

In the past 20 years, new insights into the genomic pathogenesis of prostate cancer have been provided. Large-scale integrative genomics approaches enabled researchers to characterize the genetic and epigenetic landscape of prostate cancer and to define different molecular subclasses based on the combination of genetic alterations, gene expression patterns and methylation profiles. Several molecular drivers of prostate cancer have been identified, some of which are different in men of different races. However, the extent to which genomics can explain racial disparities in prostate cancer outcomes is unclear. Future collaborative genomic studies overcoming the underrepresentation of non-white patients and other minority populations are essential.

Impact of Left-Digit Age Bias in the Treatment of Localized Prostate Cancer.

PURPOSE: Left-digit bias is a phenomenon in which the leftmost digit of a number disproportionately influences decision making. We measured the effect of left-digit age bias on treatment recommendations for localized prostate cancer. MATERIALS AND METHODS: We included men with clinically localized prostate adenocarcinoma in Surveillance, Epidemiology, and End Results from 2004 to 2018 and the National Cancer Database from 2004 to 2016. Primary outcomes were recommendations for radiation therapy and radical prostatectomy. Regression discontinuity was used to assess whether age increase from 69 to 70 years was associated with disproportionate changes in treatment recommendations. RESULTS: In Surveillance, Epidemiology, and End Results, discontinuities were found in the proportion of patients recommended for radiation among the entire cohort (effect size 2.2%, P < .01) and among patients with Gleason 6 (1.6%, P < .01), Gleason 7 (2.5%, P < .01), and Gleason ≥8 (2.1%, P < .01) cancer, while the proportion recommended for prostatectomy decreased in the entire cohort (-1.4%, P < .01) and in patients with Gleason 7 cancer (-2.4%, P < .01). In the National Cancer Database, discontinuity from age 69 to 70 was found in recommendations for radiation in the entire cohort (effect size: 3.1%, P < .01) and in patients with Gleason 6 (2.2%, P < .01), Gleason 7 (4.0%, P < .01), and Gleason ≥8 (2.3%, P < .02) cancer, while the proportion recommended for prostatectomy decreased at this cutoff in the entire cohort (effect size: -2.7%, P < .01) and patients with Gleason 6 (-2.2%, P < .01) and Gleason 7 (-3.7%, P < .01) cancer. CONCLUSIONS: In patients with localized prostate cancer, left-digit age change from 69 to 70 was associated with disproportionately increased recommendations for radiation and decreased recommendations for prostatectomy.

Underutilization of Blue Light Cystoscopy for Bladder Cancer in the United States.

Blue light cystoscopy (BLC) during transurethral resection of bladder tumor (TURBT) is guideline-recommended as it improves cancer detection and decreases recurrence of the disease. However, the extent to which BLC is used has not been established. We studied BLC use in the Premier Healthcare Database, a large, national sample that captured 158 870 index TURBT procedures between January 2011 and March 2020. Billing data were queried for the administration of hexaminolevulinate at TURBT as a proxy for BLC, and logistic regression models were constructed to identify variables associated with BLC use. BLC was used in 1.2% of index TURBT procedures over the study period. Its use increased following the American Urological Association non-muscle-invasive bladder cancer guideline publication in October 2016 but plateaued in late 2018. After adjusting for patient characteristics, higher odds for BLC use were found for academic hospitals and hospitals with higher TURBT volumes and higher radical cystectomy volumes. Within hospitals with BLC capability, predictors of a surgeon never using BLC included low surgeon TURBT volumes, low surgeon radical cystectomy volumes, and lack of mitomycin C use. Our findings highlight a concerning underutilization and stagnation in the adoption of evidence and guideline-supported intervention. PATIENT SUMMARY: Use of blue light visualization of the bladder improves the detection of cancer during removal of bladder tumors via the urethra. We reviewed records in a large US database for use of this technique and found that it is being underutilized. Since this technique improves detection of cancer in the bladder so that it can be removed to reduce recurrence, blue light visualization should be more widely used.

Incidence of Kidney Stones in the United States: The Continuous National Health and Nutrition Examination Survey.

PURPOSE: The incidence of kidney stones in the United States is currently unknown. Here, we assessed the incidence of kidney stones using recent, nationally representative data. MATERIALS AND METHODS: We used the National Health and Nutrition Examination Survey (NHANES) from 2015 to 2018. During this time participants were asked, "Have you ever had a kidney stone?" and "In the past 12 months, have you passed a kidney stone?" Demographics analyzed include age, race, gender, body mass index, history of smoking, diabetes, hypertension, hypercholesterolemia and gout. Multivariable models were used to assess the independent impact of subject characteristics on kidney stone prevalence and incidence. RESULTS: Data were available on 10,521 participants older than age 20. The prevalence of kidney stones was 11.0% (95% CI 10.1-12.0). The 12-month incidence of kidney stones was 2.1% (95% CI 1.5-2.7), or 2,054 stones per 100,000 adults. We identified significant relationships between stone incidence and subject age, body mass index, race and history of hypertension. CONCLUSIONS: Here we find a substantially higher 12-month incidence of kidney stones than previous reports. We also validate known risk factors for stone prevalence as associated with incidence. The remarkable incidence and prevalence of stones is concerning and has implications for disease prevention and allocation of medical resources.

The Impact of Race and Sex on Metastatic Bladder Cancer Survival.

OBJECTIVE: To characterize the epidemiological profile of metastatic bladder cancer (BC) and assess mortality rate with respect to race and gender across the three most common histologies of bladder cancer-Transitional Cell Carcinoma, Adenocarcinoma, and SCC (Squamous Cell Carcinoma). MATERIALS AND METHODS: The Surveillance, Epidemiology, and End Results Program database (2000-2017) was queried for all metastatic bladder cancer patients at presentation. Our primary exposure consists of four race/gender combinations. One-way ANOVA and Chi-square tests compared categorical and continuous variables across the exposure variable, respectively. Univariable and multivariable Cox proportional hazards regression analyses were used to examine the association between race/gender combinations and the overall and cancer specific survival adjusting for the other variables. RESULTS: A total of 312,846 bladder cancer patients, 6337 with distant metastases and 11,446 with regional metastases were evaluated. Black female cancer specific survival in metastatic disease was disproportionally lower compared to all race/gender for Transitional Cell Carcinoma 4.3% (95% CI: 1.6-8.9), SCC 2.6% (95% CI: 0.2-11.8), and Adenocarcinoma 6.4% (0.4%-25%). In regional metastastatic disease, worse cancer specific mortality was associated with identifying as a Black Female (aHR 1.17, P = .023), SCC (aHR 1.8, P <.001), increasing age (aHR 1.3, P <.001), and poorly differentiated grade (aHR 2.01, P <.001). CONCLUSION: Black females experience excess mortality in overall and cancer oncologic outcomes in metastatic BC. Our findings contribute to the body of research warranting examination of the impact of social determinants of health and provider decisions on BC survivorship and contribute to physician decision making in the treatment and surveillance of bladder cancer.

Practice patterns of vasal reconstruction in a large United States cohort.

We aimed to characterise diverse practice patterns for vasal reconstruction and to determine whether surgeon volume is associated with vasoepididymostomy performance at the time of reconstruction. We identified adult men who underwent vasal reconstruction from 2000 to 2020 in Premier Healthcare Database and determined patient, surgeon, cost and hospital characteristics for each procedure. We identified 3,494 men who underwent either vasovasostomy-alone (N = 2,595, 74.3%) or any-vasoepididymostomy (N = 899, 25.7%). The majority of providers (N = 487, 88.1%) performed only-vasovasostomy, 10 (1.8%) providers performed only-vasoepididymostomy and 56 (10.1%) providers performed both. Median total hospital charge of vasoepididymostomy was significantly higher than vasovasostomy ($39,163, interquartile range [IQR]$11,854-53,614 and $17,201, IQR$10,904-29,986, respectively). On multivariable regression, men who underwent procedures at nonacademic centres (OR 2.71, 95% CI 2.12-3.49) with higher volume surgeons (OR 11.60, 95% CI 8.65-16.00) were more likely to undergo vasoepididymostomy. Furthermore, men who underwent vasoepididymostomy were more likely to self-pay (OR 2.35, 95% CI 1.83-3.04, p < .001) and more likely had procedures in the Midwest or West region (OR 2.22, 95% CI 1.66-2.96 and OR 2.11, 95% CI 1.61-2.76, respectively; p < .001). High-volume providers have increased odds of performing vasoepididymostomy at the time of reconstruction but at a significantly higher cost. These data suggest possibly centralising reconstructive procedures among high-volume providers.