IRONMAN: A Novel International Registry of Men With Advanced Prostate Cancer

Abstract

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.

Pain and Its Association with Survival for Black and White Individuals with Advanced Prostate Cancer in the United States

“…IRONMAN is an international prospective cohort of individuals with no more than 90 days of life-prolonging therapy prior to enrollment for patients with CRPC and no more than 90 days of active therapy including androgen deprivation therapy (ADT) for patients with mHSPC. Participants are recruited through IRONMAN-affiliated clinicians in 16 countries ( 17 ). Study sites are primarily located in urban centers in regions with high prostate cancer mortality.…”

“…Pain was self-reported by study participants at enrollment and every 3–6 months throughout a follow-up period of up to 5 years ( 17 ). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) contains two questions on the presence and interference of pain rated on a Likert scale of 1 (“not at all”) to 4 (“very much”).…”

Nationale Register Urothelkarzinom (UroNAT) und Prostatakarzinom (ProNAT) von d-uo

“…Somit steht d-uo auch nicht in Konkurrenz zum Deutschen Krebsregister, sondern verfolgt das Ziel, weitergehende wissen- International gibt es inzwischen mehrere Versorgungsforschungsprojekte zum Prostatakarzinom: Im Jahr 2017 wurde das Projekt IRONMAN (International Registry for Men with Advanced Prostate Cancer) vorgestellt [18]. Es handelt sich um eine prospektive Studie, welches 5000 Patienten mit einem metastasierten Prostatakarzinom aus Nord-und Südamerika, Australien, Afrika und Europa (Deutschland ist nicht dabei) rekrutieren möchte und teilweise auch interventionellen Charakter hat, da auch Serumproben analysiert werden [18].…”

PROMISE Registry: A prostate cancer registry of outcomes and germline mutations for improved survival and treatment effectiveness

“…This registry was initiated to address gaps in knowledge surrounding standards of care and sequential therapy in patients with advanced prostate cancer. 37 The PROMISE Registry adds unique value in including…”

“…Finally, the IRONMAN registry (NCT03151629) is an international, population‐based, prospective registry set to accrue at least 5,000 patients with advanced prostate cancer. This registry was initiated to address gaps in knowledge surrounding standards of care and sequential therapy in patients with advanced prostate cancer 37 …”