IRONMAN Registry Seeks Real-World Data on Prostate Cancer

Researchers have released some early statistics about IRONMAN – the International Registry for Men with Advanced Prostate Cancer – that show they were successfully able to enroll an international cohort of patients with newly diagnosed advanced prostate cancer.

IRONMAN was launched in 2017; it is a prospective, international registry recruiting a minimum of 5,000 patients with advanced prostate cancer from 16 countries: the United States, Australia, Bahamas, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. Patients will be followed for at least 5 years.

As of July 2022, IRONMAN is open and enrolling in 12 of the 16 planned countries at 109 sites. To date, 2,682 patients have been enrolled in 11 of the 12 active countries; 1,006 patients were enrolled at US sites. The median age at entry is 70 years.

The majority (66%) of patients enrolled have metastatic hormone-sensitive prostate cancer, with the remaining third (34%) having castration-resistant disease.

Self-reported race/ethnicity information indicated that 11% of patients are Black and 9% are Hispanic.

Globally, about one-quarter (23%) of enrolled patients report being veterans of military service.

The researchers detailed two of the primary challenges to recruitment to date: the European Union’s (EU’s) General Data Protection Regulation (GDPR) and the COVID-19 pandemic.

“GDPR, effective May 2018, contains requirements related to the processing of personal data of individuals who are located within the EU and European Economic Area (EEA). The collection of IRONMAN data from EU/EEA sites is under the purview of GDPR regulations,” the researchers wrote in JCO Global Oncology. “Although this delayed opening sites in Europe for almost 12 months, [The Prostate Cancer Clinical Trials Consortium] PCCTC has since executed data access agreements containing EU model clauses and designated an EU representative to serve as a trusted third-party contact per GDPR requirements.”

COVID-19 stopped enrollment at almost all US sites at the beginning of the pandemic. The global impact has been variable.

“The COVID-19 pandemic has also disrupted global supply chains, affecting the ability of country-specific biorepositories to reliably obtain the necessary biospecimen collection supplies and materials. As a result, the PCCTC implemented a centralized solution using a US-based vendor to obtain and ship supplies to the country-specific biorepositories,” the researchers wrote.

The hope is to eventually expand to additional countries and enhance recruitment of patients of Hispanic ethnicity and Asian ancestry.

“This is a limitation of the registry, and we are working to identify opportunities for additional funding and engaging new partners to expand IRONMAN and enroll patients from a broader set of countries,” researchers wrote.

Reference

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