Abstract A030: International Registry for Men with Advanced Prostate Cancer (IRONMAN) study: The Nigerian experience

Abstract

Abstract Background: Prostate cancer (CaP) is a global disease with the greatest burden among Black men, including sub-Saharan African men. The International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) was established by the Prostate Cancer Clinical Trials Consortium (PCCTC) as a prospective, international cohort of men with advanced cancer. The goal of the study is to establish a population-based CaP registry and recruit patients across academic and community practices globally. The Prostate Cancer Transatlantic Consortium (CaPTC) joined the IRONMAN project in 2020 with active sites in Nigeria. Aim: The overall aims of the IRONMAN cohort are to develop a global picture of advanced CaP and facilitate a better understanding of the disease relative to clinical and molecular disease subtypes, treatment patterns, therapeutic regimens with associated adverse events, patient experiences and predictors of responses and unmet needs in treatment. This report presents the experiences of a low-resourced country, Nigeria, in launching the IRONMAN study. Methods: CaPTC officially launched the IRONMAN study in Nigeria in 2021. Set up included obtaining national ethics approval, training of the multidisciplinary teams from 4 sites and 7 sub-sites, and activation of all sites. Data collection includes baseline and follow-up data from patients. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and patient-reported outcome measures (PROMs). Physician Questionnaires are also collected from all participating sites. PCCTC maintains close monitoring of the study Results: By the 9th month of the study, the Nigerian sites had recruited 54 patients who have been followed up for 3 to 9 months. There were initial challenges with start up facilities and manpower skills. The training programs have developed a multi-disciplinary team of clinical researchers across multiple institutions, now primed to conduct clinical trials. Facilitated by CaPTC, the study has also helped strengthened multi-center national and international collaborations. Additionally, there are now several clinical trials ready sites in Nigeria, facilitated by audit of the research infrastructures across Nigeria. An added benefit is that there is an opportunity to have molecular typing of CaP in Nigeria. Conclusion: The inclusion of low-resourced sites in international studies can significantly help to improve research workforce and research capacity. The CaPTC IRONMAN sites in Nigeria are top recruiting sites for the study, underscoring the benefits of biomedical research investments in Low and Middle Income Countries. The data from Nigeria would help to better understand CaP in Black men globally. Citation Format: Ademola Alabi Popoola, Chidiebere N. Ogo, Omolara Fatiregun, Mohammed Dogo, Solomon O. Rotimi, Folakemi Odedina, Prostate Cancer Transatlantic Consortium CaPTC Investigators. International Registry for Men with Advanced Prostate Cancer (IRONMAN) study: The Nigerian experience [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A030.