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• W4320857598 abstract "Open AccessJournal of UrologyAdult Urology15 Feb 2023The Role of Physician Specialty in the Underutilization of Standard-of-Care Treatment Intensification in Patients With Metastatic Castration-sensitive Prostate CancerThis article is commented on by the following:Editorial CommentEditorial CommentEditorial Comment Umang Swami, Agnes Hong, Nader N. El-Chaar, Krishnan Ramaswamy, Brandon J. Diessner, Cori J. Blauer-Peterson, Rickard Sandin, David Nimke, and Neeraj Agarwal Umang SwamiUmang Swami *Correspondence: Huntsman Cancer Institute, University of Utah, Salt Lake City, UT telephone: 801-587-4644; E-mail Address: [email protected] https://orcid.org/0000-0003-3518-0411 Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah More articles by this author , Agnes HongAgnes Hong Astellas Pharma Inc, Northbrook, Illinois More articles by this author , Nader N. El-ChaarNader N. El-Chaar Astellas Pharma Inc, Northbrook, Illinois More articles by this author , Krishnan RamaswamyKrishnan Ramaswamy Pfizer Inc, New York, New York More articles by this author , Brandon J. DiessnerBrandon J. Diessner Optum, Eden Prairie, Minnesota More articles by this author , Cori J. Blauer-PetersonCori J. Blauer-Peterson Optum, Eden Prairie, Minnesota More articles by this author , Rickard SandinRickard Sandin Pfizer AB, Sollentuna, Sweden More articles by this author , David NimkeDavid Nimke Astellas Pharma Inc, Northbrook, Illinois More articles by this author , and Neeraj AgarwalNeeraj Agarwal * E-mail Address: [email protected] Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003370AboutAbstractPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookTwitterLinked InEmail Abstract Purpose: We evaluate utilization of treatment intensification of androgen deprivation therapy with androgen receptor pathway inhibitor/docetaxel for metastatic castration-sensitive prostate cancer patients across physician specialties. Materials and Methods: This retrospective study identified patients with metastatic castration-sensitive prostate cancer in the Optum Research Database between 2014 and 2019. Adult men with ≥1 claim for metastatic disease within 90 days before or any time after the first prostate cancer claim who received androgen deprivation therapy were included. Physician specialty, determined from medical/pharmacy claims during each line of therapy, was categorized as urologist only, oncologist only, both (urologists and oncologists), or other (other specialties). Treatment intensification and patient characteristics were analyzed descriptively. Results: Of 4,675 patients, 16% were treated by urologists only, 20% by oncologists only, 63% by both, and 1.1% by others. Most frequent first line of therapy was androgen deprivation therapy ± first-generation nonsteroidal antiandrogens (>50%). Androgen deprivation therapy + docetaxel use declined over time, while androgen deprivation therapy + androgen receptor pathway inhibitor increased. Patients seen by oncologists or both were younger, had fewer comorbidities, and were likelier to receive treatment intensification compared to those treated by urologists. By 2019, however, treatment intensification remained <40% from oncologists only or both, and <15% from urologists only. In the second and third lines of therapy, androgen deprivation therapy + androgen receptor pathway inhibitor was the most prescribed regimen across specialties (>50%). Conclusions: Treatment intensification was underused in first lines of therapy across urology and oncology specialties despite evidence of improved survival. In subsequent lines, androgen deprivation therapy + androgen receptor pathway inhibitor was prescribed more frequently across specialties. These results underscore the need for earlier treatment intensification by urologists and oncologists. Until 2014, androgen deprivation therapy (ADT) alone or in combination with first-generation nonsteroidal antiandrogens (NSAAs) was mainstay treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC),1 a disease state characterized by spread beyond the prostate to distant sites and responsiveness to ADT.2 The advent of docetaxel, followed by androgen receptor pathway inhibitor (ARPI) for mCSPC, and their use in combination with ADT, designated treatment intensification (TI), represents a paradigm change in the mCSPC therapeutic landscape.3,4 Clinical trials of combinations of ADT and docetaxel5,6 and/or ARPIs (abiraterone, apalutamide, enzalutamide, or darolutamide) have demonstrated improved survival for patients with mCSPC.7-10 Despite clinical trial evidence and guideline recommendations,4,11,12 adoption of real-world TI for mCSPC remains low.13,14 Multiple real-world studies have indicated that >50% of patients still receive only ADT ± NSAAs and are not given adequate first line of therapy (LOT1) TI with ARPIs or docetaxel.14-16 Barriers to up-front adoption of ARPIs include patient fitness, comorbid illnesses, higher drug costs, and less familiarity relative to ADT ± NSAAs. Tolerability and quality of life are also considerations but are unsupported by patient-reported outcomes.17 Currently, there are limited data on treatment patterns by specialty. Prior real-world studies have reported that patients with prostate cancer (PC) that was castration-resistant received ARPIs and chemotherapy at a higher rate under oncologists compared to urologists, but treatment patterns in patients seen by both specialties were not reported.18,19 A recent study reported LOT1 ARPI treatment rates for medical oncologists (32%) and urologists (12%) in patients with mCSPC, underscoring insufficient TI.20 In this study, we examined real-world utilization of standard-of-care (SoC) TI in insured patients with mCSPC in the U.S., focusing on the role of physician specialties. Since both urologists and oncologists often work in multidisciplinary teams in the management of PC patients, our study also assessed treatment patterns and differences in baseline characteristics among mCSPC patients seen by both specialties and by urologist only vs oncologist only. MATERIALS AND METHODS Study Design and Data Source This was a retrospective study of patients with mCSPC in the Optum Research Database, a repository of administrative claims data for more than 73 million enrollees with either commercial or Medicare Advantage information. The study period extended from January 1, 2010, to December 31, 2019, while the identification period spanned January 1, 2014, to June 30, 2019. The index date was defined as the first metastatic diagnosis date occurring within 90 days prior to, or any time after, the first claim for PC during the identification period. The baseline period was 12 months before the index date. The follow-up period spanned the index date through the earliest date of death, disenrollment, or end of study and was required to be ≥6 months unless death occurred. This study was exempt from institutional review board processes as data were restricted to de-identified patient records. Study Population The study population included adult (≥18 years old) male patients with ≥2 nondiagnostic claims for PC (International Classification of Diseases Clinical Modification ninth revision 185 or 10th revision C61 in any position) and ≥1 claim for metastatic disease without evidence of castration resistance (use of ADT or a claim for bilateral orchiectomy during the pre-index period, except if the first claim occurred within 90 days before the metastatic index date). Patients receiving other systemic anticancer treatments during baseline were excluded, except if the first claim for NSAAs, ARPIs, or docetaxel occurred within 90 days prior to the metastatic index date (supplementary Figure 1, https://www.jurology.com). Patients were grouped by physician specialty on medical or pharmacy claims during each line of therapy (LOT). “Urologist only” referred to patients with ≥1 urologist specialty claim and no oncologist claim. “Oncologist only” patients had ≥1 oncologist specialty claim and no urologist claim. “Both” referred to patients with ≥1 oncologist specialty claim along with ≥1 urologist specialty claim. The “other” category included patients without a urologist or oncologist claim. Study Measures Patient Baseline Demographics and Clinical Characteristics Baseline demographics included age, index year, geographic locations, and insurance type. Clinical characteristics included Charlson Comorbidity Index, opioid use, radiotherapy, prostatectomy, bone antiresorptive medication use, and grouped sites of metastasis—bone only, bone and nodes only, node only, and any viscera. LOTs LOT1 regimen started on the date of the first fill or infusion for a systemic treatment within 90 days pre-index through end of follow-up. It consisted of ADT and any systemic agent filled or infused within the first 180 days on or after the start of the LOT. LOT1 treatment regimens included ADT alone, NSAA (bicalutamide, flutamide, or nilutamide) + ADT, ARPI + ADT ± NSAA, or docetaxel + ADT ± NSAA. In any LOT, NSAAs received for <90 days were regarded as used for a flare and not part of a regimen. All remaining regimens were categorized as other. Second line of therapy (LOT2) and third line of therapy (LOT3) regimens were subsequent treatments for either mCSPC or metastatic castration-resistant prostate cancer (mCRPC) and included any systemic therapy filled or infused within 30 days of the start of the LOT. Given testosterone values were not available, castration status could not be confirmed. ADT was presumed to continue in LOT2 and LOT3. Statistical Analysis Baseline characteristics by LOT1 regimen and physician specialty were analyzed using descriptive statistics. Standardized mean differences were used for unadjusted comparisons between treatment groups and by specialty. Standardized differences of ≥10% indicated imbalance.21 Additionally, the association of physician specialty with TI (ADT + ARPI vs ADT ± NSAA) among patients with an index year of 2017-2019, following the approval of ARPIs and the limitations of docetaxel use for urologists, was evaluated using unconditional logistic regression adjusted for age, region, insurance type, Charlson score, comorbidities, opioid use, site, and year of first metastasis. Analyses were conducted with SAS® statistical software 9.4. RESULTS Overall Treatment Trends A total of 4,675 patients with mCSPC were identified. Approximately 70% of patients received ADT ± NSAA in LOT1 (see Table). The proportions of patients receiving ADT + ARPI ranged from 3.4% in 2014 to 24% in 2019 but remained lower than ADT ± NSAA throughout the years studied (Figure 1). Similar findings were observed in patients with aggressive disease (visceral metastases; Figure 2). Among patients with LOT2 (n=1,240) and LOT3 (n=524), ADT + ARPI was the most prescribed regimen (61% and 54%, respectively), with abiraterone (32% of LOT2 and 26% of LOT3) and enzalutamide (27% of LOT2 and 28% of LOT3) the most prescribed ARPIs (supplementary Figure 2, https://www.jurology.com). Table . Patient Baseline Demographics, Clinical Characteristics, and First Line of Therapy by Physician Specialty in Patients With Metastatic Castration-sensitive Prostate Cancer Physician specialtya,b Urologist only Oncologist only Both Sample size, No. (%)c 766 (16) 932 (20) 2,928 (63) Age, mean (SD), y 76 (8.6) 73 (9.4) 72 (9.5) Age, median (Q25-Q75), y 77 (70-84) 73 (67-81) 73 (66-81) Age group, No. (%), yd <65 80 (10) 168 (18) 630 (22) 65-74 222 (29) 340 (37) 1,038 (36) 75-79 144 (20) 159 (17) 511 (18) ≥80 320 (42) 265 (28) 749 (26) Region, No. (%)e Northeast 118 (16) 139 (15) 497 (17) Midwest 224 (29) 302 (32) 874 (30) South 324 (42) 359 (39) 1,201 (41) West 100 (13) 131 (14) 347 (12) Other/multiple 0 (0) 1 (0.11) 9 (0.31) Insurance type, No. (%)e Commercial 142 (19) 265 (28) 876 (30) Medicare 624 (82) 667 (72) 2,049 (70) Multiple 0 (0) 0 (0) 3 (0.1) CCI score Mean (SD) 3.0 (1.9) 2.7 (2.1) 2.9 (2.0) Median (Q25-Q75) 2.0 (2.0-4.0) 2.0 (2.0-4.0) 2.0 (2.0-4.0) Baseline comorbidities, No. (%)e Hypertension 582 (76) 637 (68) 2,055 (70) Stroke 41 (5.4) 29 (3.1) 120 (4.1) Acute coronary syndrome 30 (3.9) 39 (4.2) 105 (3.6) Angina pectoris 40 (5.2) 42 (4.5) 154 (5.3) Arrythmia 237 (31) 248 (27) 868 (30) Myocardial infarction 56 (7.3) 60 (6.4) 222 (7.6) Congestive heart failure 98 (13) 88 (9.4) 319 (11) Diabetes 250 (33) 246 (26) 880 (30) Lower extremity arterial occlusive disease 32 (4.2) 33 (3.5) 105 (3.6) Chronic obstructive pulmonary disease 110 (14) 134 (14) 378 (13) Treatment during 12 mo pre-metastases, No. (%)e Prostatectomy 60 (7.8) 37 (4.0) 235 (8.0) Radiation 17 (2.2) 29 (3.1) 114 (3.9) Opioid use 314 (41) 431 (46) 1,381 (47) Chronic (≥6 mo) systemic steroid use 2 (0.26) 3 (0.32) 2 (0.07) Bone antiresorptive medication use 11 (1.4) 16 (1.7) 39 (1.3) Site of metastasis, No. (%)e Bone only 488 (64) 594 (64) 1,773 (61) Bone and nodes only 21 (2.7) 37 (4.0) 91 (3.1) Node only 131 (17) 157 (17) 590 (20) Any viscera 126 (17) 144 (16) 474 (16) LOT1, No. (%)e,f ADT alone 533 (70) 389 (42) 1,291 (44) ADT + NSAA 153 (20) 207 (22) 653 (22) ADT + ARPI 57 (7.4) 160 (17) 449 (15) ADT + DOC 7 (0.91) 131 (14) 363 (12) Abbreviations: ADT, androgen deprivation therapy; ARPI, androgen receptor pathway inhibitor; CCI, Charlson Comorbidity Index; DOC, docetaxel; LOT1, first line of therapy; NSAA, first-generation nonsteroidal antiandrogen; Q, quartile; SD, standard deviation. Forty-nine patients treated by other specialties are not shown. Bolded values are standardized differences vs urologist only of >10%, indicating imbalance.21 Percentages are derived from the overall patient population. Percentages are derived from the overall sample size of each physician specialty group. Latest possible index date was June 30, 2019. Two hundred thirty-three patients treated with other regimens are not shown. Figure 1. ADT indicates androgen deprivation therapy; ARPI, androgen receptor pathway inhibitor; DOC, docetaxel; NSAA, first-generation nonsteroidal antiandrogen. Figure 2. ADT indicates androgen deprivation therapy; ARPI, androgen receptor pathway inhibitor; DOC, docetaxel; NSAA, first-generation nonsteroidal antiandrogen. Patient Baseline Demographics and Clinical Characteristics by Physician Specialty Overall, 16% of patients received care from urologists only, 20% from oncologists only, 63% from both, and 1.1% from other providers during LOT1 (see Table and supplementary Table 1, https://www.jurology.com). Results were not shown for the other providers group due to small sample size. Compared to patients seen by urologists only, patients seen by oncologists only or both were younger, had lower Charlson Comorbidity Index (for oncologists only), were more likely to have commercial coverage, were more likely to receive opioids prior to metastasis, and were less likely to have hypertension. The distribution of patients with bone, node, or visceral metastasis was similar across the physician specialty groups (see Table). LOT1 Treatment Trends by Specialty The most frequently prescribed LOT1 regimens by all specialties were either ADT alone or ADT + NSAA (see Table). ADT ± NSAA comprised nearly 90% of regimens received by patients treated by urologists only, 64% by patients treated by oncologists only, and 66% by patients treated by both. ADT + ARPI was less frequently prescribed, comprising 7.4% of regimens received by patients treated by urologists only and less than 20% of regimens received by patients treated by oncologists only (17%) or both (15%). ADT + docetaxel was nearly absent among patients treated by urologists only (0.91%), as expected, and comprised less than 15% of regimens among patients treated by oncologists only (14%) or both (12%). Additionally, most patients in the ADT + ARPI cohort who received care from both specialties during LOT1 (n=449) were prescribed ARPIs by oncologists, as evidenced by the physician specialty on ARPI pharmacy claims (78% were prescribed ARPIs by oncologists, 12% by urologists, 0.89% by both, and 9.1% by other [data not shown]). Across all specialties, the use of ADT ± NSAA in LOT1 decreased from 2014 to 2019 but it was still being used to treat over 50% of all patients by as late as 2019 (Figures 1 and 3). Although the use of TI with ARPIs in LOT1 increased over time across all specialties, by 2019, ADT + ARPI comprised approximately 11% of regimens received by patients treated by urologists only and less than 30% of LOT1 regimens by patients treated by oncologists only or both. Similarly, in 2019, ADT + docetaxel remained approximately 10% of regimens received by patients treated by oncologists only (11%) or both (9.5%; Figure 3). After adjustment for baseline characteristics among patients with an index year of 2017-2019, the odds of TI with ADT + ARPI were higher among patients treated by oncologists only (OR 3.15, 95% CI 2.21-4.49) or both (OR 2.98, 95% CI 2.18-4.07) relative to urologists only (supplementary Table 2, https://www.jurology.com). Figure 3. ADT indicates androgen deprivation therapy; ARPI, androgen receptor pathway inhibitor; DOC, docetaxel; NSAA, first-generation nonsteroidal antiandrogen. LOT2 to LOT3 Treatment Trends by Specialty In LOT2 and LOT3, ADT + ARPI was the most prescribed regimen across all specialties (>45% of regimens). ADT + sipuleucel-T comprised 23% of LOT2 regimens received by patients treated by urologists only and 3.7% of LOT2 regimens received by patients treated by oncologists only. Among patients treated by urologists only, ADT + NSAA comprised 12% of LOT2 and 14% of LOT3 regimens. Among patients treated by oncologists only or both, ADT + NSAA was infrequently prescribed in LOT2 (6.0% among oncologists only and 10% among both) or LOT3 (1.6% among oncologists only and 5.2% among both; Figure 4). Figure 4. ADT indicates androgen deprivation therapy; ARPI, androgen receptor pathway inhibitor; DOC, docetaxel; LOT, line of therapy; NSAA, first-generation nonsteroidal antiandrogen; SIP-T, sipuleucel-T. Referral Patterns Across LOTs Most patients with a subsequent LOT remained with their LOT1 physician specialty in later lines. Among the 140 patients with a LOT2 who were cared for by urologists only during LOT1, 63% remained with urologists only in LOT2 and 33% were referred to oncologists and cared for by either oncologists only or both in LOT2. Among the 246 patients with a LOT2 who were cared for by oncologists only in LOT1, 90% remained with oncologists only in LOT2, with the remainder receiving care from both or other in LOT2. Similar patterns were observed from LOT2 to LOT3 (Figure 5). Figure 5. LOT indicates line of therapy. DISCUSSION In this study, TI, ADT + ARPI, or ADT + docetaxel in LOT1 was underutilized across all specialties, even in patients with aggressive disease (visceral metastasis), despite their documented survival benefits5,8,22 and guideline-recommended SoC status.4,11,12 The majority of patients across all physician specialties were treated with ADT ± NSAA in LOT1, which is directionally consistent with prior real-world mCSPC studies.14,15,23-25 This is one of the first studies to assess treatment patterns by urologists and oncologists in the management of mCSPC and the utilization of TI. While we observed all specialties underused ADT + ARPI, a larger proportion of patients treated by oncologists only or both received ADT + ARPI compared to patients treated by urologists only, even after adjustment for observed baseline characteristics. This is consistent with a study by Heath et al, who reported similar differences in rates of LOT1 ARPI use between oncologists (32%) and urologists (12%) in patients with mCSPC,20 highlighting the need for increased TI use. Several plausible reasons underlie the differences in prescribing patterns by provider specialties.25 By 2014, oncologists already had routine access to docetaxel for the treatment of mCRPC,18 and became comfortable with TI for metastatic PC earlier than urologists.26 Urologists typically treat patients during the early stages with slowly progressing, recurrent PC and/or with limited life expectancy, and tend to refer patients to oncologists when there is disease progression or the need for chemotherapy.27,28 Oncology referrals, however, are mostly for de novo mCSPC, high volume metastasis, aggressive spread, mCRPC, or for chemotherapy.29 In our study, patients seen by urologists only were older and had greater comorbidity burden compared to patients seen by oncologists only, which could have inhibited urologists from prescribing intensified SoC treatments, particularly in LOT1.25 Our results also showed that ADT + ARPI was the most prescribed regimen in LOT2 and LOT3 across all specialties, suggesting that both oncologists and urologists, constrained by concerns of perceived tolerability, lack of urgency to treat up front, access to care, costs, quality of life, or the information gap on overall survival gain and sequencing,30 may be reserving TI for later lines.25 Such hesitation could also stem from insufficient clinician awareness about the benefits of early TI with ARPIs and current guidelines, which state there is likely minimal added benefit of long-term NSAAs in mCSPC patients.11,15 Most patients remained with their LOT1 physician in later lines, irrespective of specialty. About two-thirds of patients who initiated treatment with urologists only stayed in their care during LOT2, while about one-third were referred to oncology and their care continued with either oncologists only or both specialties. Patient retention was greater among oncologists only; most patients who initiated LOT1 treatment with oncologists only remained under oncology care in LOT2, while a small proportion continued care with both specialties and other clinicians. This pattern was repeated from LOT2 to LOT3. While our study was not designed to investigate the timing and reasons for referrals or patient retention by specialties, there may be an opportunity for urologists to become more comfortable with the delivery of ARPIs or chemotherapy agents, which may increase the proportion of patients remaining in urology care in subsequent lines. A better understanding of the reasons for underutilization of TI in mCSPC across specialties warrants further research including assessment of patient and provider preferences, PSA reduction goals, perceptions about ARPI tolerability, and financial barriers. Insights into these factors may help improve the management of patients with mCSPC. This study had inherent limitations associated with administrative claims data. Castration sensitivity is not adequately coded in claims, and an algorithm based on ADT treatment duration was used to determine castration-sensitive PC status. Certain confounding variables, including physician characteristics or patients’ access to treatments, are limited in claims data and could not be adjusted for in multivariable assessments. Referral patterns were assessed across LOTs; consequently, referrals that occurred during a LOT or after study end were not captured. These results are specific to insured U.S. patients and may not be generalizable to other populations. CONCLUSIONS TI was underused across physician specialties throughout the study, even in patients with visceral metastases. ADT ± NSAA was used prominently in LOT1, while in LOT2 and LOT3, ADT + ARPI was the most prescribed across physician specialties. Given the significant survival improvements with ARPI TI, these results highlight the need for both physician specialties to further incorporate ARPIs in earlier stages of mCSPC treatment. Additional real-world studies using contemporary data from electronic medical records could provide future insights on the underuse of TI, and treatment patterns of provider specialties. Acknowledgments Medical writing assistance was provided by Bernard Tulsi, MS, from Optum, and editorial assistance was provided by Mashal Hussain, PhD, and Jane Beck, MA, from Complete HealthVizion, IPG Health Medical Communications, funded by the study sponsors. The study sponsors participated in the design and execution of the study, data management, analysis and interpretation, manuscript preparation, review, and submission decisions. REFERENCES 1. . Current treatment strategies for advanced prostate cancer. Int J Urol.2018; 25(3):220-231. Crossref, Medline, Google Scholar 2. . Current management of metastatic castration-sensitive prostate cancer. Cancer Treat Res Commun.2021; 28:100384. Crossref, Medline, Google Scholar 3. . First results of PEACE-1: a phase 3 trial with a 2x2 factorial design of abiraterone acetate plus prednisone and/or local radiotherapy in men with de novo metastatic castration-sensitive prostate cancer (mCSPC). Virtual poster presented at American Society of Clinical Oncology (ASCO) Virtual Annual Meeting, June 4-8, 2021. Google Scholar 4. . Advanced prostate cancer: AUA/ASTRO/SUO guideline PART I. J Urol.2021; 205(1):14-21. Link, Google Scholar 5. . 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Conflict of Interest: US has received study funding and support from Astellas, reports consultancies with Astellas, Exelixis, and Seattle Genetics, and research funding from Janssen, Exelixis, and Astellas/Seattle Genetics. KR is an employee and stockholder of Pfizer. RS is an employee and stockholder of Pfizer. BJD and CJB-P are employees of Optum. NA reports consultancy roles with Astellas, AstraZeneca, Aveo, Bayer, Bristol Myers Squibb, Calithera, Clovis, Eisai, EMD Serono, Exelixis, Foundation Medicine, Genentech, Gilead, Janssen, Lilly, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics, and Seattle Genetics. Ethics Statement: In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. Author Contributions: US, AH, NNE, KR, BJD, CJB-P, RS, DN, and NA actively contributed to the study conceptualization and design, and to the analysis and interpretation of the data. BJD had complete access to all study data and takes responsibility for data integrity and accuracy of the analyses. AH, NNE, KR, BJD, CJB-P, RS, and DN contributed to study conception and design, collection and assembly of data and data analysis and interpretation. All the authors participated in the drafting, development, and review, and approved the final content of this manuscript. Data Availability: Data used to generate these results cannot be disclosed publicly. Proprietary data obtained from the Optum Research Database may be accessed only with strictest data security and privacy protocols, and oversight with a restrictive license agreement. For the Astellas criteria on data sharing, see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.© 2023 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology23 Mar 2023Editorial CommentJournal of Urology23 Mar 2023Editorial CommentJournal of Urology23 Mar 2023Editorial Comment Supplementary Materials Peer Review Report Advertisement Copyright & Permissions© 2023 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.Keywordsprostatic neoplasmsAcknowledgmentsMedical writing assistance was provided by Bernard Tulsi, MS, from Optum, and editorial assistance was provided by Mashal Hussain, PhD, and Jane Beck, MA, from Complete HealthVizion, IPG Health Medical Communications, funded by the study sponsors. The study sponsors participated in the design and execution of the study, data management, analysis and interpretation, manuscript preparation, review, and submission decisions.MetricsAuthor Information Umang Swami Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah *Correspondence: Huntsman Cancer Institute, University of Utah, Salt Lake City, UT telephone: 801-587-4644; E-mail Address: [email protected] More articles by this author Agnes Hong Astellas Pharma Inc, Northbrook, Illinois More articles by this author Nader N. El-Chaar Astellas Pharma Inc, Northbrook, Illinois More articles by this author Krishnan Ramaswamy Pfizer Inc, New York, New York More articles by this author Brandon J. Diessner Optum, Eden Prairie, Minnesota More articles by this author Cori J. Blauer-Peterson Optum, Eden Prairie, Minnesota More articles by this author Rickard Sandin Pfizer AB, Sollentuna, Sweden More articles by this author David Nimke Astellas Pharma Inc, Northbrook, Illinois More articles by this author Neeraj Agarwal Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah * E-mail Address: [email protected] More articles by this author Expand All Support: This study was funded by Astellas Pharma Inc and Pfizer Inc, the codevelopers of enzalutamide. Conflict of Interest: US has received study funding and support from Astellas, reports consultancies with Astellas, Exelixis, and Seattle Genetics, and research funding from Janssen, Exelixis, and Astellas/Seattle Genetics. KR is an employee and stockholder of Pfizer. RS is an employee and stockholder of Pfizer. BJD and CJB-P are employees of Optum. NA reports consultancy roles with Astellas, AstraZeneca, Aveo, Bayer, Bristol Myers Squibb, Calithera, Clovis, Eisai, EMD Serono, Exelixis, Foundation Medicine, Genentech, Gilead, Janssen, Lilly, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics, and Seattle Genetics. Ethics Statement: In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed. Author Contributions: US, AH, NNE, KR, BJD, CJB-P, RS, DN, and NA actively contributed to the study conceptualization and design, and to the analysis and interpretation of the data. BJD had complete access to all study data and takes responsibility for data integrity and accuracy of the analyses. AH, NNE, KR, BJD, CJB-P, RS, and DN contributed to study conception and design, collection and assembly of data and data analysis and interpretation. All the authors participated in the drafting, development, and review, and approved the final content of this manuscript. Data Availability: Data used to generate these results cannot be disclosed publicly. Proprietary data obtained from the Optum Research Database may be accessed only with strictest data security and privacy protocols, and oversight with a restrictive license agreement. For the Astellas criteria on data sharing, see: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx. Advertisement Advertisement PDF downloadLoading ..." @default.
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