Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)

Our intent is to establish the International Registry to Improve Outcomes in Men with
Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000
men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a
population-based registry and recruit patients across academic and community practices from
Australia, Brazil, Canada, Ireland, Sweden, Switzerland, the United Kingdom (UK), and the US.
Target accrual number and number of participating sites are subject to change based on
accrual, funding, and interest in participation by other international sites. This cohort
study will facilitate a better understanding of the variation in care and treatment of
advanced prostate cancer across countries and across academia and community based practices.

Detailed data will be collected from patients at study enrollment and then during follow-up,
for a minimum of three years. Patients will be followed prospectively for overall survival,
clinically significant adverse events, comorbidities, changes in cancer treatments, and
PROMs.

PROMs questionnaires will be collected at enrollment, every three months for the first and
second year then every six months.

Physician Questionnaires will be collected from all participating sites at patient
enrollment, time of first change in treatment and/or one year follow-up, at each subsequent
change of treatment, and discontinuation of treatment.

As such, this registry will help identify the treatment sequences or combinations that
optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at
enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free
DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes
of disease that predict response and resistance to specific therapeutics. Additionally, every
effort will be made to collect blood specimen at each subsequent change in treatment. When
feasible, existing tumor tissue may be collected for correlation with described blood based
studies. All samples will be used for future research. This cohort study will provide the
research community with a unique biorepository to identify biomarkers of treatment response
and resistance.