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Conditions › Prostate Cancer › NCT03151629

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Recruiting · NCT03151629 · Observational (researchers observe without assigning treatment) · Lead sponsor: Prostate Cancer Clinical Trials Consortium

View the official record on ClinicalTrials.gov →
Prostate Cancer

Interventions studied

Standard of Care

What this trial is about

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.

Who can take part

Age range
21 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)

Eligibility criteria (as published)

• 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

Where it is running

60 locations listed across 22 US states.

Showing 60 of 121 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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