Harvard T.H. Chan School of Public Health, Boston, MA.
Prostate Cancer Clinical Trials Consortium, New York, NY.
JCO Glob Oncol. 2022 Nov;8:e2200154. doi: 10.1200/GO.22.00154.
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.
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.
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.
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.
描述一个新成立的国际注册处，该注册处招募来自学术和社区实践的不同患者，以解决该人群未满足的需求。
IRONMAN（晚期前列腺癌男性国际注册处）于 2017 年启动，是一个晚期前列腺癌患者的前瞻性队列研究。该研究将招募 5000 名转移性激素敏感前列腺癌（mHSPC）或去势抵抗性前列腺癌（CRPC）患者，来自澳大利亚、巴哈马、巴巴多斯、巴西、加拿大、爱尔兰、牙买加、肯尼亚、尼日利亚、挪威、南非、西班牙、瑞典、瑞士、英国和美国。该研究正在收集数据类型，以研究不同国家、学术、社区和政府实践中晚期前列腺癌治疗和护理的差异，重点是临床结局、患者报告结局、流行病学数据、生物学亚型和临床医生问卷。
截至 2022 年 7 月，在 12 个活跃国家中的 11 个国家共招募了 2682 名符合条件的患者。66%的患者患有 mHSPC，34%的患者患有 CRPC。根据自我报告，11%的患者是黑人，9%的患者是西班牙裔。有 5 家退伍军人事务医疗中心正在招募患者。全球有 23%的患者报告自己曾是军队的退伍军人。
据我们所知，这是第一个新诊断为晚期前列腺癌的国际队列，旨在描述患者管理、经验和结局的变化。IRONMAN 的目的是确定最佳的治疗方案，以提高生存率，了解患者报告的结果，并探索新的生物标志物，以了解治疗抵抗机制。IRONMAN 的见解将为 mHSPC 和 CRPC 患者的未来临床管理提供信息和指导。这项队列研究将提供真实世界的证据，以促进更好地了解晚期前列腺癌患者的生存情况。
