Community Urology Practices Research Articles

Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP).

Approximately 25% to 50% of patients with high-risk localized prostate cancer experience biochemical recurrence (BCR) within 2 years of radical prostatectomy. The Apa-RP study (NCT04523207) investigated whether adjuvant apalutamide plus androgen deprivation therapy (ADT) in high-risk patients who have undergone radical prostatectomy improved BCR-free survival. Apa-RP was a multicenter, open-label, single-arm, phase 2 study conducted in community urology practices in the US. High-risk patients who had radical prostatectomy received 12 cycles of apalutamide (240 mg daily; 28-day cycles) plus ADT. The primary end point was BCR-free survival. Secondary end points included testosterone recovery (≥150 ng/dL) and safety. One hundred eight patients were enrolled; median age was 66.0 years (range 46.0-77.0 years). Median preoperative PSA and baseline testosterone were 7.6 ng/mL (range 2.2-62.7 ng/mL) and 340.0 ng/dL (range 43.0-939.0 ng/dL), respectively. The BCR-free rate at 24 months (12 months after completion of planned therapy) was 100% (90% CI 93-100). Serum testosterone recovery rate (≥50 and ≥150 ng/dL) 12 months after treatment completion was 96% (95% CI 88-98) and 77% (95% CI 66-85), respectively. Overall, 107 (99%) patients experienced treatment-emergent adverse events, with 24 (22%) experiencing grade 3 to 4 events. In Apa-RP, BCR-free survival was 100% with 77% of patients having testosterone recovery (≥150 ng/dL) within 12 months of actual treatment completion and a manageable safety profile. These results provide proof of concept that treatment intensification with 12 cycles of apalutamide plus ADT could become an option for patients with high-risk localized prostate cancer who have undergone radical prostatectomy. ClinicalTrials.gov Identifier: NCT04523207.

Outcomes of a universal germline screening program in a community urology practice.

The role of germline genetic testing in urologic oncology has expanded in recent years. However, implementation of genetic testing in community practices remains a challenge, often due to limited access to qualified genetics trained providers. In this study, we report outcomes of a universal germline screening program in a community urology practice. Between November 2021 and September 2022, all patients referred for urology clinic visits at Frederick Health (Frederick, MD, USA) were provided an online genetics screening questionnaire prior to the visit. Responses were compared against National Comprehensive Cancer Network (NCCN) criteria for germline testing. Those who met criteria were provided educational materials at the end of the questionnaire, and then counseled by a trained urologic oncologist (HC) in the clinic or referred to a genetic counselor prior to testing. Testing was performed with a 36-gene pan-cancer panel (CancerNext) or a 14-gene targeted prostate cancer panel (ProstateNext), with or without additional RNA analysis (RNAinsight) (Ambry Genetics, CA, USA). Demographic and clinical parameters, as well as genetic testing results, were retrospectively collected under IRB approval. In the study period, 765 patients were seen over 1370 clinic visits. Of these, 505 patients (66.0%) completed the screening questionnaire. The majority were completed via email (54.5%) with the remainder (45.5%) via text message. Of the patients who completed screening, 125/505 (24.7%) met NCCN criteria for germline testing. 58/125 patients (46.4%) who met criteria underwent germline testing, of whom 5/58 (8.6%) had distinct pathogenic mutations identified. These included actionable mutations in BRCA1, BRCA2, and CHEK2, as well as an additional pathogenic mutation in NBN. Variants of unknown significance were identified in 8/58 patients (13.8%) in 11 total genes. Challenges to implementation of this program included meeting institutional requirements for genetic testing consent, facilitating specimen collection in clinic, and integration of results into the electronic health record. Genetic risk assessment for high-risk individuals is feasible as part of a universal screening program in a community urology practice. Approximately 8% of tested patients were found to have pathogenic germline mutations, which is consistent with contemporary tertiary referral cohorts.

Telemedicine Utilization in the COVID-19 Era: Patterns of Care in Community Urology Practice.

The acute phase of the COVID-19 pandemic disrupted ambulatory care in the US, and in response telemedicine was adopted rapidly but unevenly across specialties and time. This study examines the utilization of telemedicine in the specialty of urology across a 3-year period (before, during, and after the onset of the pandemic) with the objective of describing patterns, costs, and trends in telemedicine utilization in the specialty. The study data were drawn from the adjudicated claims of 1726 providers in 41 independent (privately owned) practices across the US from March 2019 to February 2022. Encounters were indexed to providers to allow for comparisons of utilization across time. Telehealth adoption was defined as the percentage of encounters eligible for reimbursement by telehealth actually conducted by telehealth. A total of 3,630,474 individual patients and 16,130,444 unique encounters were included in our analysis. Telehealth-eligible (evaluation and management) encounters declined sharply from a prepandemic baseline of 262 per provider per month (pppm) to a nadir of 164 pppm in April 2020 (acute phase), but quickly rebounded to 264 pppm by June 2020 (postacute phase). Telehealth adoption among urology providers in this study was 0% prior to March 2020, peaked at 46% in April 2020, and then declined rapidly in the months afterward. Telehealth adoption in urology spiked abruptly during the acute phase of the pandemic before declining to a low but stable level above prepandemic baseline. These findings may have implications for the broader role of telemedicine in the delivery of urologic care.

Prostate-specific antigen (PSA) response among patients with metastatic castration-sensitive prostate cancer (mCSPC) initiated on apalutamide (APA) or abiraterone acetate (ABI) in real-world urology practices.

53 Background: Recently approved oral therapies APA and ABI (plus prednisone) are effective mCSPC treatments. Prior real-world evidence showed that, relative to ABI, patients who initiated APA had significantly higher rates of PSA decline ≥90% (PSA90), which has been associated with longer overall survival. The objective of this study was to compare PSA90 response among an enhanced cohort of patients with mCSPC initiated on APA or ABI. Methods: Electronic medical records from PPS Analytics including data from US community urology practices were linked with administrative claims from the Komodo Health Solutions Research Database. Androgen receptor signaling inhibitor (ARSI)-naïve patients with mCSPC with ≥12 months of pre-index clinical activity were selected into the APA or ABI cohort based on their first paid claim/dispensation on or after 17 Sep 2019 (index date). Patients were followed to earliest of index ARSI discontinuation or switch, radiopharmaceutical use, end of insurance or clinical activity, or end of data availability (30 Sep 2022). Inverse probability treatment weighting (IPTW) was used to reduce potential pre-index confounding, controlling for age, race, region, insurance payer, index year, time from metastasis to index date, time from first prostate cancer (PC) diagnosis to index date, metastasis locations, de novo PC, use of androgen deprivation therapy, first-generation antiandrogens or chemotherapy, most recent PSA and testosterone levels, and most recent Gleason score. PSA90 was defined as the earliest attainment of ≥90% decline in PSA relative to pre-index (most recent value within 13 weeks). The proportion of patients achieving PSA90 was compared using a weighted Kaplan-Meier analysis and the time-to-PSA90 response was compared using a weighted Cox proportional hazards model. Results: A total of 917 APA and 632 ABI patients were identified. Patient characteristics were balanced with IPTW (Table). By 6 months post-index, 80.9% of APA and 72.8% of ABI patients had a PSA measurement. By 6 months, significantly more APA patients attained a PSA90 response, as compared to ABI patients (P < 0.001; Table). Median time-to-PSA90 was 3.5 months for APA patients and 8.8 months for ABI patients. Conclusions: This real-world study supports previous findings that a greater percentage of patients with mCSPC in the US initiating APA achieved deep PSA response compared to those initiating ABI. [Table: see text]

Real-world comparison of prostate-specific antigen (PSA) response in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (APA) or enzalutamide (ENZ).

51 Background: APA and ENZ, two androgen receptor synthesis inhibitors (ARSIs), used in combination with androgen deprivation therapy (ADT) are among the recommended treatments for patients with mCSPC. Deep PSA response, evaluated as ≥90% PSA decline (PSA90), is an important outcome after ARSI initiation, with early, deep response associated with longer survival. The primary objective of this study was to compare PSA90 response in ARSI-naïve patients with mCSPC by 6 months after initiating APA or ENZ in real-world clinical practice. Methods: Linked electronic medical record (EMR) data of US community urology practices in the from PPS Analytics and administrative health data from Komodo Health Solutions Research Database were evaluated. Patients with mCSPC were selected into two cohorts, based on the index date, defined as the first paid pharmacy claim or in-office dispensation for APA or ENZ on or after 16 Dec 2019. Patients were required to have ≥12 months of pre-index EMR clinical activity. Pre-index characteristics (i.e., age, race, geographic region, payer type, index year, time from metastasis, time from first prostate cancer [PC] diagnosis, de novo PC, ADT use, first-generation antiandrogen use, chemotherapy use, metastasis locations, most recent PSA level, testosterone level, and Gleason score) were balanced between cohorts with inverse-probability treatment weighting (IPTW). Patients were followed from index date until the earliest of index ARSI discontinuation or switch, radiopharmaceutical initiation, end of open administrative claim or EMR clinical activity, or end of data availability (30 Sep 2022). PSA90 was defined as the earliest ≥90% decline in PSA relative to most recent pre-index PSA. The proportion of patients achieving PSA90 was compared using a weighted Kaplan-Meier analysis and the time-to-PSA90 response was compared using a weighted Cox proportional hazards model. Results: In total 860 APA and 869 ENZ patients were identified. Patient pre-index characteristics were balanced with IPTW (Table). By 6 months post-index, 80.3% of APA and 75.0% of ENZ patients had ≥1 PSA test result. By 6 months, significantly more APA patients attained a PSA90 response, as compared to ENZ patients (p=0.005; Table). The median time to PSA90 response was 3.5 months for APA and 4.9 months for ENZ. Conclusions: This US real-world study of patients with mCSPC demonstrated that treatment with APA produces a deep, early PSA response by 6 months in a greater percentage of patients than treatment with ENZ. [Table: see text]

Protocol of the Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) study: a pragmatic, prospective multicenter observational cohort study of recurrent high-grade non-muscle invasive bladder cancer

BackgroundBladder cancer poses a significant public health burden, with high recurrence and progression rates in patients with non-muscle-invasive bladder cancer (NMIBC). Current treatment options include bladder-sparing therapies (BST) and radical cystectomy, both with associated risks and benefits. However, evidence supporting optimal management decisions for patients with recurrent high-grade NMIBC remains limited, leading to uncertainty for patients and clinicians. The CISTO (Comparison of Intravesical Therapy and Surgery as Treatment Options) Study aims to address this critical knowledge gap by comparing outcomes between patients undergoing BST and radical cystectomy.MethodsThe CISTO Study is a pragmatic, prospective observational cohort trial across 36 academic and community urology practices in the US. The study will enroll 572 patients with a diagnosis of recurrent high-grade NMIBC who select management with either BST or radical cystectomy. The primary outcome is health-related quality of life (QOL) at 12 months as measured with the EORTC-QLQ-C30. Secondary outcomes include bladder cancer-specific QOL, progression-free survival, cancer-specific survival, and financial toxicity. The study will also assess patient preferences for treatment outcomes. Statistical analyses will employ targeted maximum likelihood estimation (TMLE) to address treatment selection bias and confounding by indication.DiscussionThe CISTO Study is powered to detect clinically important differences in QOL and cancer-specific survival between the two treatment approaches. By including a diverse patient population, the study also aims to assess outcomes across the following patient characteristics: age, gender, race, burden of comorbid health conditions, cancer severity, caregiver status, social determinants of health, and rurality. Treatment outcomes may also vary by patient preferences, health literacy, and baseline QOL. The CISTO Study will fill a crucial evidence gap in the management of recurrent high-grade NMIBC, providing evidence-based guidance for patients and clinicians in choosing between BST and radical cystectomy. The CISTO study will provide an evidence-based approach to identifying the right treatment for the right patient at the right time in the challenging clinical setting of recurrent high-grade NMIBC.Trial registrationClinicalTrials.gov, NCT03933826. Registered on May 1, 2019.

Real world US community urology adherence to prostate cancer guidelines.

449 Background: According to a 2010 Surveillance, Epidemiology, and End Results (SEER) Medicare analysis of prostate cancer (PCa) patients between 1992 and 2005, urologists accounted for more health services provided to PCa patients than any other specialty. Our study assessed the concordance of PCa care with two treatment-related Performance Indicators (PIs) derived from National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) in a real-world setting of community urologists. Methods: This retrospective analysis used PPS Analytics (Specialty Networks) Patient Population Health Management Platform, capturing 90 community urology practices with approximately 539,000 PCa patients treated between 7/1/2019-6/30/2022. Two PIs were identified from NCCN Guidelines through consultation with expert urologists to measure the quality of PCa care. PI-1 was defined as the proportion mCSPC patients who initiated an NCCN Category 1 preferred regimen for mCSPC. Guideline changes on 01/01/2020 created a need for two patient stratifications in PI-1. Patients in PI-1.1 had a mCSPC diagnosis between 05/2002 - 12/2019. Patients in PI-1.2 had a mCSPC diagnosis between 01/2020 - 06/2021. PI-2 was defined as the proportion of newly diagnosed intermediate-to-high risk localized PCa (Gleason score ≥ 7 or PSA ≥ 10) who received concurrent ADT with external beam radiation therapy (EBRT) based on the NCCN Guidelines recommendation for concurrent ADT in newly diagnosed intermediate-to-high risk localized PCa (LPC) receiving EBRT. Multi-level multi-variable regression was used to assess factors associated with concordance for each PI. Results: See table. Conclusions: Although changes in NCCN guidelines after 1/2020 led to improved systemic treatment in mCSPC, most patients still did not receive care concordant with recent NCCN recommendations. Our findings highlight opportunities for improving the quality of PCa care in a real-world community urology setting, notably for treatment in mCSPC. Future research should investigate reasons for deviating from NCCN preferred systemic regimens in mCSPC and intervene as appropriate.[Table: see text]

Using patient-reported outcomes to assess the impact of germline genetic testing on prostate cancer patients.

10607 Background: Germline genetic testing (GGT) affords prostate cancer (PCa) patients (pts) opportunities for targeted therapies, prevention and cascade testing. Patient-reported outcomes (PRO) can evaluate physician effectiveness in promoting patient test comprehension and clinical decision making, which are critical to realize the benefits of GGT. PROs from a large PCa GGT study among urologists were analyzed. Methods: A prospective study enrolled unselected PCa pts from 15 primarily community urology practices. Pts underwent 84-gene GGT, with PROs collected via electronic or paper surveys >1-month post GGT. Differences in proportions were determined using two-tailed Fisher’s exact test and significance was set at <0.05. Results: PROs were completed by 561/982 (57%) pts (85% white, 82% non-metastatic, median age at testing 70 years). 59 (11%) pts had positive results, 247 (44%) negative and 255 (46%) variants of uncertain significance (VUS). 72% accurately recalled their result (range, 50% [VUS]-93% [negative]). 66% of positive pts, 80% negative and 54% VUS correctly understood if their result was associated with cancer risk or not. 72% of positive pts had or planned to complete ≥1 physician recommendations, significantly more than negative or VUS pts (Table). Most pts reported that their test result reduced their concerns (40%) or did not impact their level of concern (52%) regarding their PCa diagnosis, treatment or followup. 19% of positive pts reported increased concern. Conclusions: GGT for PCa was deployed without causing undue concern and resulted in adherence to physician recommendations. Still, there is room for improvement in how test results (especially VUS) and recommendations are communicated to pts. [Table: see text]

(265) Socioeconomic Factors Affecting Patient Engagement with Sensitive Urologic Social Media Content

Abstract Introduction As the use of social media becomes more prevalent within healthcare practices, it is important to understand how patients may engage with social media posts by their physicians. The conditions addressed within the field of urology are often particularly sensitive in nature, particularly within the realm of sexual medicine. Therefore, patients might be less likely to engage with social media posts from their urologists based on their own comfort levels and privacy concerns. A previous study evaluating this interaction determined the likelihood to engage varied based on age and gender. However, social media engagement patterns in sensitive topics based on socioeconomic background have not been previously evaluated. Objective This study aims to determine the likelihood of patients in a community urology practice to engage with sensitive social media posts by their urologist according to socioeconomic factors. The likelihood to engage actively (defined as commenting or sharing) versus passively (defined as liking a post) on two different topics within the scope of urology was determined. The two topics used were erectile dysfunction (ED)/urinary incontinence and kidney stone prevention. Methods Participants completed a survey that included basic demographic questions as well as questions determining their potential likelihood to engage on the different topics using a visual analog 5-point Likert scale. Responses on the Likert scale were given a value of one (very unlikely) to five (very likely), and a two-tailed Mann-Whitney U test with an α of 0.05 was used to determine the significance of differences in responses. For analysis of the Likert scale responses, only those respondents who had social media accounts were included. Results The final sample consisted of 293 responses with a 93.0% response rate. Of respondents, 65.7% had a social media account. Of those respondents that had a social media account, 50.5% had an annual income under $50,000. There was no significant difference in the likelihood to follow their urologist on social media for those with an annual income under $50,000 in comparison to those over $50,000. When looking at the overall likelihood of engagement, those with an annual income of less than $50,000 were more likely to actively engage compared to those making over $50,000 (p-value = 0.02. When stratifying by topic, those making less than $50,000 were more likely to actively engage on the topic of ED/urinary incontinence than those making more than $50,000 (p-value = 0.02). Conclusions Patient education via social media is an effective tool for urology practices to engage with patients. Engagement with this content is greater among lower-income patients. Further investigation is needed to determine whether increased engagement with online content translates to improved health outcomes. Disclosure No

Attainment of early, deep prostate-specific antigen response in metastatic castration-sensitive prostate cancer: A comparison of patients initiated on apalutamide or enzalutamide.

Deep prostate-specific antigen (PSA) response, defined as a ≥90% decline in PSA (PSA90), is an important early response indicator for achieving radiographic progression-free and overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with a next-generation androgen signaling inhibitor (ASI), such as apalutamide or enzalutamide. The objective of this study was to compare deep PSA response among patients with mCSPC newly initiated on apalutamide or enzalutamide. Clinical data from 69 community urology practices in the United States were evaluated. Patients with mCSPC were classified into cohorts based on their first dispensation (index date) for apalutamide or enzalutamide and were followed until the earliest of treatment discontinuation, initiation of a new next-generation androgen receptor signaling inhibitor, end of clinical activity (including death), or end of data availability (03/05/2021). Inverse probability of treatment weights (IPTW) were used to reduce baseline confounding. PSA90 was defined as the earliest ≥90% PSA decline relative to baseline PSA. The proportion of patients achieving PSA90 and time to PSA90 were reported using weighted Kaplan-Meier analysis and weighted Cox proportional hazards models, respectively. The apalutamide and enzalutamide cohorts comprised 186 and 165 patients, respectively. Patient characteristics were generally well balanced after IPTW. By 6 months, patients initiated on apalutamide had a 56% greater likelihood of attaining PSA90 than those initiated on enzalutamide (P = 0.014). This result remained significant through the end of the observation period. The median time to achieving PSA90 was 3.1 months with apalutamide and 5.2 months with enzalutamide. This real-world study demonstrated that apalutamide initiation is associated with a significantly higher likelihood of achieving ≥90% reduction in PSA as compared to initiation of enzalutamide. Moreover, this deep PSA response was observed to occur earlier with apalutamide treatment than with enzalutamide.

Comparison of prostate-specific antigen response in patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or abiraterone acetate: A retrospective cohort study.

Deep prostate-specific antigen (PSA) response (≥90% reduction in PSA [PSA90]) is an important early response indicator of radiographic progression-free survival and overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC). This study compared PSA90 responses by 6 months between patients with mCSPC at first use of apalutamide or abiraterone acetate, both androgen receptor signaling inhibitors. Clinical data from 77 community urology practices in the United States were analyzed. Patients with mCSPC were classified into treatment cohorts based on their first filled prescription (index date) for apalutamide or abiraterone acetate on or after September 17, 2019 (approval date of apalutamide for mCSPC). Patients were followed from the index date until the earliest of index treatment discontinuation, treatment switch, end of clinical activity, or end of data availability (September 17, 2021). Inverse probability of treatment weighting (IPTW) was used to ensure similarity in distribution of baseline characteristics between cohorts. PSA90 was defined as the earliest attainment of ≥90% reduction in PSA relative to baseline (most recent value within 13 weeks pre-index). Time to PSA90 between cohorts was compared by weighted Kaplan-Meier analysis and with Cox proportional hazards models. A total of 364 patients treated with apalutamide and 147 treated with abiraterone acetate met the study criteria. Patient characteristics were well balanced after IPTW. By 6 months post-index, patients initiated on apalutamide were 53% more likely to achieve PSA90 than those initiated on abiraterone acetate (P = 0.016). Similar results were observed by 9 and 12 months post-index (both P ≤ 0.019). The median time to PSA90 was 3.5 months for the apalutamide cohort and not reached for the abiraterone acetate cohort. In real-world patients with mCSPC, significantly more patients achieved PSA90 with apalutamide than with abiraterone acetate, and this response was achieved earlier with apalutamide.

MP54-12 IMPLEMENTATION AND OUTCOMES OF A UNIVERSAL GERMLINE SCREENING PROGRAM IN A COMMUNITY UROLOGY PRACTICE

You have accessJournal of UrologyCME1 Apr 2023MP54-12 IMPLEMENTATION AND OUTCOMES OF A UNIVERSAL GERMLINE SCREENING PROGRAM IN A COMMUNITY UROLOGY PRACTICE Neil Mendhiratta, Herman Hauver, Whitley Hatton, Andrew Ostrusky, Devika Sathe, Patricia Rice, Sandeep Gurram, and Heather Chalfin Neil MendhirattaNeil Mendhiratta More articles by this author , Herman HauverHerman Hauver More articles by this author , Whitley HattonWhitley Hatton More articles by this author , Andrew OstruskyAndrew Ostrusky More articles by this author , Devika SatheDevika Sathe More articles by this author , Patricia RicePatricia Rice More articles by this author , Sandeep GurramSandeep Gurram More articles by this author , and Heather ChalfinHeather Chalfin More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003307.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The role of germline genetic testing in urologic oncology has expanded in recent years. However, implementation of genetic testing in community practices remains a challenge, often due to limited access to qualified genetics trained providers. In this study, we report outcomes of a universal germline screening program in a community urology practice. METHODS: Between August 1st, 2021 and September 19th, 2022, all patients referred for urology clinic visits at Frederick Health (Frederick, MD, USA) were provided an online genetics screening questionnaire prior to the visit. Responses were compared against National Comprehensive Cancer Network (NCCN) criteria for germline testing. Those who met criteria were provided educational materials at the end of the questionnaire, and then counselled by a trained urologic oncologist (HC) in the clinic or referred to a genetic counselor prior to testing. Testing was performed with a 36-gene pan-cancer panel (CancerNext) or a 14-gene targeted prostate cancer panel (ProstateNext), with or without additional RNA analysis (RNAinsight) (Ambry Genetics, CA, USA). Demographic and clinical parameters, as well as genetic testing results, were retrospectively collected under IRB approval. RESULTS: In the study period, 846 patients were seen over 1,580 clinic visits. Of these, 540 patients (63.8%) completed the screening questionnaire. The majority were completed via email (59.7%) with the remainder (40.3%) via text message. Of the patients who completed screening, 136/540 (25.2%) met NCCN criteria for germline testing. 49/136 patients (36%) who met criteria underwent germline testing, of whom 6/49 (12.2%) had distinct pathogenic mutations identified. These included actionable mutations in BRCA1 (c.4616dupT), BRCA1 (c.4964_4982del19), BRCA2 (p.D2723H; c.8167G>C), and CHEK2 (1100delC); additional pathogenic mutations were found in LZTR1 (c.774delT;p.F258Lfs*93) and NBN (p.S706,c.2117c>G). Variants of unknown significance were identified in 8/49 patients (16.3%) in 9 total genes. Challenges to implementation of this program included meeting institutional requirements for genetic testing consent, facilitating specimen collection in clinic, and integration of results into the electronic health record. CONCLUSIONS: Genetic risk assessment for high-risk individuals is feasible as part of a universal screening program in a community urology practice. Approximately 12% of tested patients were found to have pathogenic germline mutations, which is consistent with contemporary tertiary referral cohorts. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e758 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neil Mendhiratta More articles by this author Herman Hauver More articles by this author Whitley Hatton More articles by this author Andrew Ostrusky More articles by this author Devika Sathe More articles by this author Patricia Rice More articles by this author Sandeep Gurram More articles by this author Heather Chalfin More articles by this author Expand All Advertisement PDF downloadLoading ...

MP76-20 TRENDS IN SURGICAL MANAGEMENT OF BENIGN PROSTATIC HYPERPLASIA: DATA FROM THE AUA QUALITY (AQUA) REGISTRY

You have accessJournal of UrologyCME1 Apr 2023MP76-20 TRENDS IN SURGICAL MANAGEMENT OF BENIGN PROSTATIC HYPERPLASIA: DATA FROM THE AUA QUALITY (AQUA) REGISTRY Charles Jones, Benjamin Breyer, Rachel Mbassa, William Meeks, Raymond Fang, and Matthew Cooperberg Charles JonesCharles Jones More articles by this author , Benjamin BreyerBenjamin Breyer More articles by this author , Rachel MbassaRachel Mbassa More articles by this author , William MeeksWilliam Meeks More articles by this author , Raymond FangRaymond Fang More articles by this author , and Matthew CooperbergMatthew Cooperberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003350.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The list of surgical options for benign prostatic hyperplasia (BPH) has exploded in recent years, but little is known about the uptake of these new procedures in community urology practice. In this study we aimed to examine surgical BPH practices and trends across the country using the American Urological Association Quality Registry (AQUA). METHODS: The AQUA Registry was launched in 2014 to centralize quality reporting and improvement, primarily among community-based urology practices. Data regarding surgical BPH management from 2014-2021 were accessioned directly from electronic health records at 245 practices across the country. Procedures were grouped by CPT code. These included prostatic urethral lift (Urolift), transurethral incision of the prostate (TUIP), transurethral resection of the prostate (TURP), repeat TURP, laser coagulation of the prostate, laser vaporization of the prostate, holmium laser enucleation of the prostate (HoLEP), transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA), transurethral destruction of the prostate by water vapor thermal therapy (Rezum), simple prostatectomy, and other genitourinary procedure. Patients were characterized by race and age. Practice location was also examined. RESULTS: The mean age of BPH diagnosis was 66.4 years old. 72% were White, 7% Black, 1% Asian, and 20% unknown. A total of 300,215 BPH procedures were recorded from 2014-2021. TURP had the greatest overall decline from a relative incidence of 40.1% of total BPH procedures in 2016 to 25.6% in 2021. TURP was used for 32% of White patients, 34% of Black patients, and 26% of Asian patients. Urolift use grew from 0.7% of cases in 2014 to 30.1% in 2021. HoLEP comprised approximately 1% of procedures throughout the time period studied. CONCLUSIONS: There has been a large shift in the procedures of choice for surgical management of BPH within community urology practices in the United States, with Urolift having a significant increase in total and relative proportions of procedures performed since its FDA approval in 2013. There has been a concurrent decrease in TURP, while HoLEP has stayed relatively consistently uncommon in community practice. Source of Funding: AQUA Registry is funded by the American Urological Association © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1100 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Charles Jones More articles by this author Benjamin Breyer More articles by this author Rachel Mbassa More articles by this author William Meeks More articles by this author Raymond Fang More articles by this author Matthew Cooperberg More articles by this author Expand All Advertisement PDF downloadLoading ...

MP29-14 PROSTATE-SPECIFIC ANTIGEN RESPONSE AND TIME-TO-CASTRATION RESISTANCE AMONG PATIENTS WITH METASTATIC CASTRATION SENSITIVE PROSTATE CANCER INITIATED ON APALUTAMIDE, ENZALUTAMIDE, OR ABIRATERONE ACETATE

You have accessJournal of UrologyCME1 Apr 2023MP29-14 PROSTATE-SPECIFIC ANTIGEN RESPONSE AND TIME-TO-CASTRATION RESISTANCE AMONG PATIENTS WITH METASTATIC CASTRATION SENSITIVE PROSTATE CANCER INITIATED ON APALUTAMIDE, ENZALUTAMIDE, OR ABIRATERONE ACETATE Benjamin Lowentritt, Shawn Du, Carmine Rossi, Frederic Kinkead, Dexter Waters, Bronwyn Moore, Patrick Lefebvre, Dominic Pilon, and Erik Muser Benjamin LowentrittBenjamin Lowentritt More articles by this author , Shawn DuShawn Du More articles by this author , Carmine RossiCarmine Rossi More articles by this author , Frederic KinkeadFrederic Kinkead More articles by this author , Dexter WatersDexter Waters More articles by this author , Bronwyn MooreBronwyn Moore More articles by this author , Patrick LefebvrePatrick Lefebvre More articles by this author , Dominic PilonDominic Pilon More articles by this author , and Erik MuserErik Muser More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003257.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Next-generation androgen inhibitors (AI), including apalutamide (APA), enzalutamide (ENZ), and abiraterone acetate (ABI), are approved to treat patients with metastatic castration sensitive prostate cancer (mCSPC). Among patients with mCSPC, prostate-specific antigen (PSA) response is associated with increased overall survival and decreased castration resistance (CR), an important indicator of disease progression. This study described real-world PSA response and progression to CR among patients with mCSPC treated with APA, ENZ, or ABI in the US. METHODS: Data from 77 community-based urology practices (9/2018–4/2022) were used to evaluate patients with mCSPC newly initiated on APA, ENZ, or ABI using in-office dispensing data (index date is first dispensation date). On-treatment PSA response was defined as: 1) a post-index ≥90% decline in PSA (PSA90) from baseline (using the closest PSA value within 13 weeks prior to or on the index date) and 2) a post-index decline to ≤0.2 ng/mL (PSA0.2) among those with baseline PSA >0.2 ng/mL. The descriptive proportion of patients achieving a PSA response or progressing to CR was described separately for each cohort using Kaplan-Meier (KM) analysis up to 12- and 24-months post-index, respectively. RESULTS: A total of 589 APA, 597 ENZ, and 553 ABI patients were evaluated. Mean age at index was 76 years in each group. Mean baseline PSA was 19.2 ng/mL (APA), 18.8 ng/mL (ENZ), and 24.3 ng/mL (ABI). KM rates for PSA response and progression to CR are shown in the Table. PSA90 by 12 months was achieved by 72% (APA), 62% (ENZ), and 55% (ABI) of patients. PSA0.2 by 12 months was achieved by 81% (APA), 63% (ENZ), and 58% (ABI) of patients. By 24 months, progression to CR was observed in 34% (APA), 39% (ENZ), and 45% (ABI) of patients. CONCLUSIONS: This is among the first observational studies to describe real-world PSA response and progression to CR in mCSPC patients treated with AIs in US community urology practices. While AIs with higher proportions achieving PSA90 or PSA0.2 were observed to have lower rates of progression to CR, further studies adjusting for baseline characteristics are needed to understand this relationship. Source of Funding: Janssen Scientific Affairs, LLC. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e387 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Benjamin Lowentritt More articles by this author Shawn Du More articles by this author Carmine Rossi More articles by this author Frederic Kinkead More articles by this author Dexter Waters More articles by this author Bronwyn Moore More articles by this author Patrick Lefebvre More articles by this author Dominic Pilon More articles by this author Erik Muser More articles by this author Expand All Advertisement PDF downloadLoading ...

Prostate-specific antigen response and clinical progression-free survival in Black and White men with chemotherapy-naïve metastatic castration-resistant prostate cancer treated with enzalutamide in a real-world setting

BackgroundIn the United States, Black men have a higher incidence of prostate cancer (PC)-related mortality than men of other races. Several real-world studies in advanced PC suggest, however, that Black men respond better to novel hormonal therapies than White men. Data on treatment responses to enzalutamide by race are limited. We assessed real-world prostate-specific antigen (PSA) response and clinical progression-free survival (cPFS) of Black vs. White men with chemotherapy-naïve PC treated with enzalutamide.MethodsThis retrospective cohort study included patients with PC who initiated enzalutamide treatment from 2014 to 2018 in the IntrinsiQ Specialty Solutions™ database, a collection of electronic medical records from community urology practices. Index date was the date of the first prescription for enzalutamide, used as a proxy for metastatic castration-resistant PC (mCRPC). Patients who had undergone chemotherapy and/or abiraterone therapy were excluded. Kaplan–Meier and Cox models adjusted for baseline characteristics were used to estimate PSA response and cPFS by race.ResultsThe study included 214 Black and 1332 White men with chemotherapy-naïve PC presumed to have mCRPC based on the enzalutamide indication during the study period. Black men were younger and had higher baseline median PSA levels than White men. Enzalutamide therapy duration, follow-up time, and number of post-index PSA tests were similar between races. In multivariable analyses, the risk of patients achieving a ≥ 50% PSA decline was similar, whereas a numerically higher trend of ≥90% PSA decline was observed in Black men (HR 1.23; 95% CI 0.93–1.62 [P = 0.14]). In the multivariable analysis, Black men had significantly better cPFS (HR 0.82; 95% CI 0.68–0.98 [P = 0.03]).ConclusionsBlack and White men with presumed chemotherapy-naïve mCRPC had similar PSA responses when treated with enzalutamide, but Black men had better cPFS than White men. Further research is warranted to validate these findings.

Utility of PSA density in patients with PI-RADS 3 lesions across a large multi-institutional collaborative.

Prostate MRI detecting PI-RADs = 3 lesions has low diagnostic utility for prostate malignancy. Use of PSA density has been suggested to further risk-stratify these men, to potentially avoid biopsies in favor of monitoring. We evaluate the ability of PSA density (PSAd) to risk-stratify PIRADs 3 lesions across patients who underwent a prostate biopsy in a large multi-institutional collaborative. Pennsylvania Urology Regional Collaborative (PURC) is a voluntary quality improvement collaborative of 11 academic and community urology practices in Pennsylvania and New Jersey. A retrospective analysis was performed on all patients in the PURC database that had a prostate MRI with PI-RADs 3 lesions only. PSA just before the MRI and prostate size reported on MRI were used to calculate the PSA. Clinicopathologic data were evaluated. Univariable analysis using Chi-Square and Kruskal Wallis tests and multivariable logistic regression were used to identify predictors of any PCa, and clinically significant prostate cancer (csPCa) was defined as ≥ Grade Group 2 (GG2.) RESULTS: Between May 2015 and March 2021, 349 patients with PIRADs 3 lesions only were identified and comprised the cohort of interest. Median PSA was 5.0 with a prostate volume of 58cc and a median PSA density of 0.11, 10.6% of the cohort was African American with 81.4% being Caucasian. Significant prostate cancer was detected in 70/349 (20.0%) men. Smaller prostate volume, abnormal DRE, and higher PSAd were significantly associated with clinically significant prostate cancer on univariable analysis. In men with PSAd <0.15, 31/228 (13.6%) harbored csPCa. Multivariable analysis confirmed that men with PSAd >0.15 were more likely to harbor clinically significant prostate cancer (P < 0.001). Across a large regional collaborative, patients with PIRADs 3 lesions on mpMRI were noted to have clinically significant cancer in 20% of biopsies. Using a PSA density cut-off of 0.15 may result in missing clinically significant prostate cancer in 13.6%. This information is useful for prebiopsy risk stratification and counseling.

Democratizing germline genetic testing and its impact on prostate cancer clinical decision-making.

10500 Background: Approximately 10-15% of prostate cancer (PCa) patients (pts) have a pathogenic germline variant (PGV). Identification of a PGV has important implications affecting decisions regarding cancer screening, treatment selection, and family cascade testing. There exists limited data documenting real world recommendations post germline genetic testing (GGT). This study was designed to collect clinician reported outcomes from PCa pts who underwent GGT. Methods: An IRB-approved, nationwide, prospective registry recruited unselected PCa pts from 15 community and academic urology practices. Pts underwent an 84-gene panel test, with clinical outcomes collected via clinician-completed case report forms &gt; 1-month post GGT. Statistical significance was determined by two-tailed Fisher’s exact test. Results: 982 predominantly white (75.9%), non-metastatic (80.7%) males with PCa were recruited; 56.9% met National Comprehensive Cancer Network (NCCN) GGT criteria. Average age was 65.3 years at PCa diagnosis. PGVs, most commonly CHEK2 (17) and BRCA2 (10), were identified in 100 (10.2%) pts; 34 (34%) of these did not meet NCCN GGT criteria. Among PGV positive pts, 241 recommendations were made (Table). They were more likely to have changes to treatment (p &lt; 0.0001), follow up (p &lt; 0.0001) and cascade testing recommendations (p &lt; 0.0001) than those with negative/variant of uncertain significance (VUS) results. There were no significant differences in changes to treatment (p = 0.4471) or follow up (p = 0.861) for pts who met NCCN criteria versus those who did not. 7 pts with PGVs received targeted therapy or were referred to a clinical trial. 5 pts with VUS results were also referred to a clinical trial. Among these 12 pts, 6 (50%, 2 CHEK2 PGV, 1 ATM PGV, 1 VUS each ATM, BLM, CHEK2) did not meet NCCN GGT criteria. Referral to a genetic counselor was the most common follow up recommendation for those with PGV (38 patients, 38%) and VUS results (66, 13.7%). The most commonly reported impact to health outcomes for those with negative results was knowledge/reassurance (38, 7.88%). Conclusions: This study showed that GGT did influence PCa pts care. Appropriately, pts with PGVs received a greater number of recommendations for relatives, changes to follow up and treatment. [Table: see text]

Exploring Variation in the Receipt of Recommended Active Surveillance for Men with Favorable-Risk Prostate Cancer.

Men on active surveillance for favorable-risk prostate cancer do not receive all the recommended testing. Reasons for variation in receipt are unknown. We combined prospective registry data from the Michigan Urological Surgery Improvement Collaborative, a collaborative of 46 academic and community urology practices across Michigan, with insurance claims from 2014 to 2018 for men on active surveillance for favorable-risk prostate cancer. We defined receipt of recommended surveillance according to the collaborative's low-intensity criteria as: annual prostate specific antigen testing and either magnetic resonance imaging or prostate biopsy every 3 years. We assessed receipt of recommended surveillance among men with ≥36 months of followup (246). We conducted multilevel analyses to examine the influence of the urologist, urologist and primary care provider visits, and patient demographic and clinical factors on variation in receipt. During 3 years of active surveillance, just over half of men (56.5%) received all recommended surveillance testing (69.9% annual prostate specific antigen testing, 72.8% magnetic resonance imaging/biopsy). We found 19% of the variation in receipt was attributed to individual urologists. While increasing provider visits were not significantly associated with receipt, older men were less likely to receive magnetic resonance imaging/biopsy (≥75 vs <55 years, adjusted odds ratio 0.07; 95% confidence interval 0.01-0.81). Nearly half of men on active surveillance for favorable-risk prostate cancer did not receive all recommended surveillance. While urologists substantially influenced receipt of recommended testing, exploring how to leverage patients and their visits with their primary care providers to positively influence receipt appears warranted.

PD41-10 THE UTILITY OF PSA DENSITY IN PATIENTS WITH PI-RADS 3 LESIONS ACROSS A LARGE MULTI-INSTITUTIONAL COLLABORATIVE

You have accessJournal of UrologyCME1 May 2022PD41-10 THE UTILITY OF PSA DENSITY IN PATIENTS WITH PI-RADS 3 LESIONS ACROSS A LARGE MULTI-INSTITUTIONAL COLLABORATIVE Johnathan Drevik, Zafardjan Dalimov, Kaynaat Syed, John Danella, Laurence Belkoff, Adam Reese, Jeffrey Tomaszewski, Edouard Trabulsi, Eric Singer, Bruce Jacobs, Jay Raman, Thomas Guzzo, Andres Correa, Marc Smaldone, Robert Uzzo, and Serge Ginzburg Johnathan DrevikJohnathan Drevik More articles by this author , Zafardjan DalimovZafardjan Dalimov More articles by this author , Kaynaat SyedKaynaat Syed More articles by this author , John DanellaJohn Danella More articles by this author , Laurence BelkoffLaurence Belkoff More articles by this author , Adam ReeseAdam Reese More articles by this author , Jeffrey TomaszewskiJeffrey Tomaszewski More articles by this author , Edouard TrabulsiEdouard Trabulsi More articles by this author , Eric SingerEric Singer More articles by this author , Bruce JacobsBruce Jacobs More articles by this author , Jay RamanJay Raman More articles by this author , Thomas GuzzoThomas Guzzo More articles by this author , Andres CorreaAndres Correa More articles by this author , Marc SmaldoneMarc Smaldone More articles by this author , Robert UzzoRobert Uzzo More articles by this author , and Serge GinzburgSerge Ginzburg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002602.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prostate MRI detecting PI-RADs = 3 lesions has low diagnostic utility. Use of PSA density has been suggested to further risk-stratify these men, to potentially avoid biopsies in favor of monitoring. We evaluate the ability to PSA density (PSAd) to risk-stratify PIRADs 3 lesions across patients who underwent a biopsy in a large multi-institutional collaborative. METHODS: Pennsylvania Urology Regional Collaborative (PURC) is a voluntary quality improvement collaborative of 11 academic and community urology practices in Pennsylvania and New Jersey. A retrospective analysis was performed on all patients in the PURC database that had a prostate MRI with PI-RADs 3 lesions only. PSA just prior to the MRI and prostate size reported on MRI were used to calculate the PSAd. Clinicopathologic data were evaluated. Univariable analysis using Chi-Square and Kruskal Wallis tests and multivariable logistic regression were used to identify predictors of total and clinically significant prostate cancer (csPCa) defined as > Grade Group 2 (GG2). RESULTS: Between May 2015 and March 2021, 349 patients with only PIRADs 3 lesion(s) were identified and comprised the cohort of interest. Clinicopathologic characteristics are summarized in Table 1. Significant prostate cancer was detected in 70/349 (20.0%) of men. Smaller prostate volume, abnormal DRE, and higher PSAd were significantly associated with clinically significant prostate cancer. In men with PSAd <0.15, 31/228 (13.6%) harbored csPCa. Multivariable analysis confirmed that men with PSAd >0.15 were more likely to harbor clinically significant prostate cancer (p<0.001, Table 2). CONCLUSIONS: Across a large regional collaborative, patients with a PIRADs 3 lesions on mpMRI were noted to have clinically significant cancer in 20%. Using PSA density cut-off of 0.15 to further risk stratify these patients may result in missing clinically significant prostate cancer in 13.6%. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e693 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Johnathan Drevik More articles by this author Zafardjan Dalimov More articles by this author Kaynaat Syed More articles by this author John Danella More articles by this author Laurence Belkoff More articles by this author Adam Reese More articles by this author Jeffrey Tomaszewski More articles by this author Edouard Trabulsi More articles by this author Eric Singer More articles by this author Bruce Jacobs More articles by this author Jay Raman More articles by this author Thomas Guzzo More articles by this author Andres Correa More articles by this author Marc Smaldone More articles by this author Robert Uzzo More articles by this author Serge Ginzburg More articles by this author Expand All Advertisement PDF DownloadLoading ...

PD35-07 ANALYSIS OF DISCONTINUATION RATES AND CAUSES OF EARLY DISCONTINUATION OF NOVEL ORAL HORMONE THERAPY IN MEN WITH ADVANCED PROSTATE CANCER

You have accessJournal of UrologyCME1 May 2022PD35-07 ANALYSIS OF DISCONTINUATION RATES AND CAUSES OF EARLY DISCONTINUATION OF NOVEL ORAL HORMONE THERAPY IN MEN WITH ADVANCED PROSTATE CANCER David Gangwish, Bernadette Zwaans, Paul Miriani, Wesley Dejoie, Andrina Ajo, Connor Ervin, Jeff Sarazin, and Jason Hafron David GangwishDavid Gangwish More articles by this author , Bernadette ZwaansBernadette Zwaans More articles by this author , Paul MirianiPaul Miriani More articles by this author , Wesley DejoieWesley Dejoie More articles by this author , Andrina AjoAndrina Ajo More articles by this author , Connor ErvinConnor Ervin More articles by this author , Jeff SarazinJeff Sarazin More articles by this author , and Jason HafronJason Hafron More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002593.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prostate cancer (PCa) is the second most common cause of cancer-specific death in US men. Novel oral hormone therapy (NHT) significantly prolongs survival and maintains quality of life in advanced PCa patients. Despite known benefits, these medications are commonly discontinued. The study evaluated the prevalence of early discontinuation of NHT, the determinants of early discontinuation and the effect of changing NHT on duration of treatment. METHODS: A retrospective cohort study of 333 patients with advanced PCa who started a NHT in a single community urology practice in the United States between February 2016 and July 2020 were evaluated. NHT medication, start date of treatment, reason for discontinuation, and discontinuation date were collected. Additional data included demographics, stage of PCa, PSA at time of NHT initiation, Gleason score, and prior PCa treatments. The cohort was divided into 2 subgroups, those did not change medication (Group A) and those that did change to a different NHT (Group B). Student’s t-test, Chi-square test, and Kaplan-Meier survival analysis were carried out to determine significant differences between groups (SPSS). RESULTS: At one year 28.8% of patient’s had early discontinuation of NHT. The most common reasons for discontinuation were side effects and death at 34.4% each. Group A (282 patients) and Group B (51 patients) discontinued treatment at a rate of 31%, 88%, respectively. Primary reasons for discontinuation in group A versus group B was due to side effects (36% vs 47%) or cancer progression (34% vs 49%). More patients in group B were deceased than in group A (58.8% vs 29.4%). Of those that discontinued, patients remained on NHT for an average of 382 days in group A versus 593 days in group B (Figure 1, Kaplan-Meier analysis p = 0.003). In group B, patients on average discontinued first NHT after 330 days and continued secondary NHT for an additional 263 days. CONCLUSIONS: Side effects and cancer progression were the main reasons for discontinuing NHT treatment. Providing patients with alternative NHT significantly increases the duration of treatment. It is important for clinicians to understand the causes of early discontinuation to develop strategies to maximize duration of therapy for management of advanced PCa. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e629 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Gangwish More articles by this author Bernadette Zwaans More articles by this author Paul Miriani More articles by this author Wesley Dejoie More articles by this author Andrina Ajo More articles by this author Connor Ervin More articles by this author Jeff Sarazin More articles by this author Jason Hafron More articles by this author Expand All Advertisement PDF DownloadLoading ...