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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.