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PURPOSE To describe a newly established international registry recruiting diverse patients with advanced prostate cancer across academic and community practices to address unmet needs in this population. PATIENTS AND METHODS Initiated in 2017, IRONMAN (International Registry for Men with Advanced Prostate Cancer) is a prospective cohort of patients with advanced prostate cancer. The study will enroll 5,000 patients with metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC), recruited from Australia, the Bahamas, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, South Africa, Spain, Sweden, Switzerland, the United Kingdom, and the United States. The study is collecting datatypes to study variation in care and treatment of advanced prostate cancer across countries and across academic, community-based, and government practices with a focus on clinical outcomes, patient-reported outcomes, epidemiologic data, biologic subtypes, and clinician questionnaires. RESULTS Through July 2022, 2,682 eligible patients were enrolled in 11 of 12 active countries. Sixty-six percent of patients have mHSPC, and 34% have CRPC. On the basis of self-report, 11% of patients are Black and 9% are Hispanic. Five Veterans Affairs Medical Centers are enrolling patients. Globally, 23% of patients report being veterans of military service. CONCLUSION To our knowledge, this is the first international cohort of people newly diagnosed with advanced prostate cancer designed to describe variations in patient management, experiences, and outcomes. IRONMAN aims to identify optimal treatment sequences to improve survival, understand patient-reported outcomes, and explore novel biomarkers to understand treatment resistance mechanisms. Insights from IRONMAN will inform and guide future clinical management of people with mHSPC and CRPC. This cohort study will provide real-world evidence to facilitate a better understanding of the survivorship of people with advanced prostate cancer.

85 Background: Patients with advanced prostate cancer (APC) experience high mortality and increasingly deteriorating quality of life due to the disease itself and the therapies they are treated with. Despite recent advances in the treatment landscape, disparities in outcomes have only worsened. There is an urgent need to identify disparities in treatment patterns and outcomes in advanced disease in diverse populations. The International Registry for Men with Advanced Prostate Cancer (IRONMAN) is uniquely equipped to address these needs. Methods: IRONMAN is a prospective registry initiated in 2017 with a planned accrual of 5000 patients with newly diagnosed metastatic hormone-sensitive (mHSPC) and castration-resistant (CRPC) prostate cancer. As of 10/11/2022, 2890 patients have enrolled from 14 countries at 113 sites, with 2 more countries pending activation. Sites were selected to create a diverse cohort across race/ethnicity, geography and socioeconomic factors. Patients are followed for survival, clinically significant adverse events, changes in cancer treatments, biomarkers, and Patient-Reported Outcome Measures (PROMs). This analysis includes patients with treatment data reported from Baseline through Month 3 as of October 2021 (n=1931, 9 countries). Results: Patients were recruited across the USA (N=799), Australia (146), Canada (282), Spain (238), England (205), and all other countries (261). 61% had mHSPC, and 39% had CRPC at enrollment with little variation in these proportions across countries. Based on self-report, 87% of patients were White, 9% Black, 4% reported other races/ethnicities, and 353 did not report race. In the US, 18% of patients were Black. Globally, 22% of respondents reported current or former military service. The most common first systemic therapy on study was androgen receptor signaling inhibitors (ARSI) +/- ADT in 1039 (54%), ranging between 12% and 66% of patients by country. 19% received chemotherapy +/- ADT and 18% received ADT alone. ARSI use varied by age, race, and metastatic disease site. Conclusions: Our preliminary results highlight our ability to successfully enroll and follow APC patients from 113 sites across 14 countries, with 2890 of 5000 planned patients enrolled. Accrual is greater in de novo mHSPC patients than anticipated. Differences in treatment patterns are already emerging, with more ARSI use in the mHSPC setting in North America than other regions. Our data demonstrates that IRONMAN participating sites are rapidly adopting new treatment recommendations into clinical practice of real-world patients.

INTRODUCTION AND OBJECTIVE:Men with localized prostate cancer (CaP) face several treatment options. While multinational studies typically focus on variations in CaP incidence and morbidity, limited...

TPS190 Background: Men with advanced prostate cancer (APC) experience high mortality and severely impacted quality of life due to the disease itself as well as its therapies, with Black men facing the highest disease burden. The treatment landscape for APC is rapidly changing; however, little is known about the real-life experience of men receiving new therapies. There is an urgent need to identify disparities in treatment patterns and outcomes in advanced disease, based on patient and country demographics. The International Registry for Men with Advanced Prostate Cancer (IRONMAN) is uniquely equipped to meet these needs. Methods: IRONMAN is a population-based prospective cohort of men with newly diagnosed metastatic hormone-sensitive (mHSPC) and castration-resistant (CRPC) prostate cancer aiming to enroll 5,000 men across 16 countries (Australia, the Bahamas, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom, Untied States). Patients are followed prospectively for overall survival, clinically significant adverse events, changes in cancer treatments, biomarkers, and Patient-Reported Outcome Measures (PROMs). Data is collected via longitudinal electronic questionnaires from patients and providers as well as blood samples and medical records. IRONMAN is currently enrolling in 10 countries at 103 sites. Sites were selected to create a diverse cohort across race/ethnicity, rural/urban populations, socioeconomic factors, and geographic regions. Of the first 1,865 men enrolled to date, 60% have mHSPC and 40% have CRPC; overall, 9% of men (18% in the US) self-identify as Black and 82% identify as white (78% in the US). 60% (N = 1,111) of this cohort has been enrolled outside of the US, and the median age at study entry is 70 years. The distribution and demographics of patients are continuously monitored to inform ongoing enrollment efforts. The IRONMAN Diversity Working Group meets monthly to discuss barriers and strategies to enhance enrollment of a racially and ethnically diverse population. The Low- and Middle-Income Country Working Group addresses the unique needs of men being recruited from the Caribbean and African sites in addition to supporting broad oncology efforts in these regions. These efforts support IRONMAN’s larger goal to investigate disparities in the care of patients with APC, having potential implications for decreasing racial disparities in survival outcomes. Clinical trial information: NCT03151629.

69 Background: While population-based estimates of advanced prostate cancer survivors are lacking, an estimated 180,000 men in the US are living with metastatic prostate cancer. Their survivorship experience is distinct from localized patients as they suffer quality of life detriments both due to the severity of disease and its therapies. We examined quality-of-life indictors among men in the IRONMAN global registry of advanced prostate cancer. Methods: IRONMAN (International Registry of Men with Advanced Prostate Cancer) is a population-based prospective study of men with newly diagnosed advanced, metastatic hormone-sensitive (mHSPC) and castration-resistant prostate cancer (CRPC) enrolled from 16 countries. We report data from first 1865 men enrolled, 1567 who completed a baseline Patient Reported Outcome Measure (PROM) in the US (N=581), Canada (N=245), Spain (N=166), UK (N=204), Australia (N=126), Switzerland (N=88), Sweden (N=70), Ireland (N=46), and Brazil (N=41). PROMs are collected at baseline and every three months using electronic (90%) or paper versions of validated questionnaires. Results: The cohort includes 1,128 men with mHSPC and 737 with CRPC. Based on self-report, 9% of men overall (18% in the US) are Black and 83% are white (78% in the US). Sleep problems were common among men at enrollment, with 59% of men reporting problems with insomnia. The prevalence was similarly high among men with mHSPC or CRPC disease. Ten percent of men reported that pain substantially interfered with daily activities, and 24% reported pain had some effect. Physical functioning was high among both mHSPC (median 93.3, 80-100) and CRPC (median 86.7, 73.3-100) patients based on EORTC QLQ-30. Global health status was similar between the two groups (median 75, 58.3 - 83.3). More than 25% of men reported some cognitive impairment at baseline. Financial difficulties due to the disease and treatment were quite high, ranging from 12% in Sweden, 16% in Canada and Spain, 34% in the US, and 46% in Brazil. Conclusions: Men with advanced prostate cancer experience a range of quality of life detriments which impair overall health. While at baseline, many of these measures were similar among men with mHSPC and CRPC, we will continue to monitor these over time to examine changes in quality of life associated with disease progression and treatments. A longer-term goal is to identify opportunities for intervention to improve quality of life and potentially improve survival. Clinical trial information: NCT03151629.

Background: Although there are considerable racial and ethnic disparities in prostate cancer incidence and mortality in the United States and globally, clinical trials often do not reflect disease incidence across racial and ethnic subgroups. This study aims to comprehensively review the reporting of race and ethnicity data and the representation of race and ethnicity across prostate cancer treatment-, prevention-, and screening-based clinical trials. Methods: Seventy-two global phase III and IV prevention, screening, and treatment prostate cancer clinical trials with enrollment start dates between 1987 and 2016 were analyzed in this study, representing a total of 893,378 individual trial participants. Availability and representation of race and ethnicity data by trial funding type, temporal changes in the racial/ethnic diversity of participants, and geographic representation of countries were assessed. Results: Of the 72 trials analyzed, 59 (81.9%) had available race data, and 11 (15.3%) of these trials additionally reported ethnicity. Of the trials reporting data, participants were overwhelmingly white men (with the highest proportion in U.S. nonpublicly funded trials), comprising over 96% of the study population. The proportion of white participants in prostate cancer clinical trials has remained at over 80% since 1990. Geographically, Africa and the Caribbean were particularly underrepresented with only 3% of countries included. Conclusions: Trial participants continue to be majority white despite the known racial disparities in prostate cancer clinical outcomes. Impact: Current and future trials must use novel recruitment strategies to ensure enrollment of underrepresented men. Targeting the inclusion of African and Caribbean medical centers is crucial to achieve equity in representation.

PURPOSE To detail the process for importing a defined data set into a centralized global registry via a secure file transfer platform and to understand the barriers to the establishment of a centralized global registry. RESULTS A bespoke solution was developed to allow transmission of data from international local data centers to a centralized repository. Data elements included in the import template were drawn from existing International Consortium for Health Outcome Measurement variables and refined to ensure accurate benchmarking as well as feasibility in data completeness. The data set was organized in accordance with the prostate cancer care trajectory. Key considerations in developing the data transfer platform included import file format, process of input validation, and technical provisions. Given the diversity in the legislation and ethical requirements with respect to consent, data handling, and cross-border data transfer across geographic locations, we encouraged each local data center to consult with its legal advisors and research ethics committee early on in the process. DISCUSSION A global collaboration, although highly valuable, posed many challenges because of inconsistent methods of data collection. User acceptance of a system is paramount to the success of establishing a metaregistry. Local information technology support and regular regression testing ensures quality and maintenance of the database. CONCLUSION We developed a Web-based system to facilitate the collection and secure storage of common data, which is scalable and secure. It is anticipated that through systematic recording of data, global standards of clinical practice and outcomes of care will see vast improvements.

Background: The Movember funded TrueNTH Global Registry (TNGR) aims to improve care by collecting and analysing a consistent dataset to identify variation in disease management, benchmark care delivery in accordance with best practice guidelines and provide this information to those in a position to enact change. We discuss considerations of designing and implementing a quality of care report for TNGR. Methods: Eleven working group sessions were held prior to and as reports were being built with representation from clinicians, data managers and investigators contributing to TNGR. The aim of the meetings was to understand current data display approaches, share literature review findings and ideas for innovative approaches. Preferred displays were evaluated with two surveys (survey 1: 5 clinicians and 5 non-clinicians, 83% response rate; survey 2: 17 clinicians and 18 non-clinicians, 93% response rate). Results: Consensus on dashboard design and three data-display preferences were achieved. The dashboard comprised two performance summary charts; one summarising site’s relative quality indicator (QI) performance and another to summarise data quality. Binary outcome QIs were presented as funnel plots. Patient-reported outcome measures of function score and the extent to which men were bothered by their symptoms were presented in bubble plots. Time series graphs were seen as providing important information to supplement funnel and bubble plots. R Markdown was selected as the software program principally because of its excellent analytic and graph display capacity, open source licensing model and the large global community sharing program code enhancements. Conclusions: International collaboration in creating and maintaining clinical quality registries has allowed benchmarking of process and outcome measures on a large scale. A registry report system was developed with stakeholder engagement to produce dynamic reports that provide user-specific feedback to 132 participating sites across 13 countries.

Background: Prostate cancer incidence and mortality rates differ substantially by race and ethnicity globally and within the United States. Despite these disparities, many cancer clinical trials have a lack of representation of U.S. minority groups, and race is often overlooked when reporting trial results. The purpose of this study is to assess diversity of participants in prostate cancer clinical trials. Methods: Available trials were identified through a systematic review of clinical trials using the U.S. National Library of Medicine's Clinical Trials Database and PubMed. Completed global phase III and phase IV clinical trials evaluating treatment, primary prevention, or screening of prostate cancer with published results were included in the analysis. Trials were analyzed for availability of race and ethnicity data and categories represented. Temporal and geographic trends were analyzed. Results: Of the 61 treatment-based clinical trials analyzed, 39 (63.9%) reported race data. Twenty-one race categories were represented across the trials, with the largest categories being White (83.2% of participants), Black or African American (7.5%), other/not reported (4.4%), and Asian (2.7%). All other race categories represented less than 2% of participants each. Six trials (9.8%) additionally reported ethnicity data: 81.1% of participants with data were not Hispanic or Latino, 7.6% of participants were Hispanic or Latino, and 11.3% of participants did not indicate their ethnicity. Of four prevention-based trials, all had data available on race, but only one additionally reported ethnicity. The majority of participants in prevention trials were White (84.6%), with similar representation across race and ethnicity categories compared to the treatment clinical trials. Only one of the five screening trials had available race data, again showing majority White participants (85.0%). Categories unique to prevention and screening trials include Hispanic (non-African American), Hispanic (African American), non-Hispanic White, and non-Hispanic Black. The Swedish branch of the European Randomized Study for Screening for Prostate Cancer (ERSPC) reported country of origin rather than race data: 15% of participants were non-European. Additionally, diversity of participants has not changed over time, and representation of countries in trials is unequal. Conclusions: More than one-third of prostate cancer clinical trials do not report race/ethnicity data. Moreover, there is significant variability in the race categories reported in trials, with 26 categories represented across the analyzed trials. Of the trials reporting race data, over 80% of participants were White. Current initiatives, such as the International Registry of Men with Advanced Prostate Cancer (IRONMAN), are aiming to recruit representative populations to decrease racial and ethnic disparities and ensure that men at risk for or diagnosed with prostate cancer are better represented in research and receive the best possible care. Citation Format: Emily Rencsok, Latifa Bazzi, Rana McKay, Franklin Huang, Adam Friedant, Jake Vinson, Jelani Zarif, Stacey Simmons, Paul Villanti, Philip Kantoff, Elisabeth Heath, Daniel George, Lorelei Mucci. Diversity of enrollment in prostate cancer clinical trials: Current status and future directions [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr B022.

PurposeGlobally, prostate cancer treatment and outcomes for men vary according to where they live, their race and the care they receive. The TrueNTH Global Registry project was established as an international registry monitoring care provided to men with localised prostate cancer (CaP).ParticipantsSites with existing CaP databases in Movember fundraising countries were invited to participate in the international registry. In total, 25 Local Data Centres (LDCs) representing 113 participating sites across 13 countries have nominated to contribute to the project. It will collect a dataset based on the International Consortium for Health Outcome Measures (ICHOM) standardised dataset for localised CaP.Findings to dateA governance strategy has been developed to oversee registry operation, including transmission of reversibly anonymised data. LDCs are represented on the Project Steering Committee, reporting to an Executive Committee. A Project Coordination Centre and Data Coordination Centre (DCC) have been established. A project was undertaken to compare existing datasets, understand capacity at project commencement (baseline) to collect the ICHOM dataset and assist in determining the final data dictionary. 21/25 LDCs provided data dictionaries for review. Some ICHOM data fields were well collected (diagnosis, treatment start dates) and others poorly collected (complications, comorbidities). 17/94 (18%) ICHOM data fields were relegated to non-mandatory fields due to poor capture by most existing registries. Participating sites will transmit data through a web interface biannually to the DCC.Future plansRecruitment to the TrueNTH Global Registry-PCOR project will commence in late 2017 with sites progressively contributing reversibly anonymised data following ethical review in local regions. Researchers will have capacity to source deidentified data after the establishment phase. Quality indicators are to be established through a modified Delphi approach in later 2017, and it is anticipated that reports on performance against quality indicators will be provided to LDCs.