International Registry for Men With Advanced Prostate Cancer (IRONMAN)
c16-170 (primary)
NCI-2017-01549
Summary
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, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria,
Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United
States (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 five 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 and every three months thereafter.
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 due to progression of disease. 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.
Eligibility
- • Willing and able to provide written informed consent and privacy authorization for the
release of personal health information.
NOTE: Privacy authorization may be either included in the informed consent or obtained
separately.
- Males 21 years of age and above
- Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy,
radical prostatectomy or TURP Or Documented histopathology or cytopathology of
prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease
typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or
para-aortic lymph nodes) AND a serum concentration of PSA >20ng/mL at the time of
initial prostate cancer diagnosis
- No previous diagnosis of a second, non-prostate malignancy that requires additional
systemic therapy except cancer in situ of bladder and basal cell cancer of skin
Treatment Sites in Georgia
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