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International Registry for Men With Advanced Prostate Cancer (IRONMAN)
NCT03151629 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- OTHER Standard of Care
Study Locations (20)
Illinois
- University of Illinois at Chicago — Chicago
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago
- University of Chicago — Chicago
- Kishwaukee Cancer Center — DeKalb
- Delnor Cancer Center — Geneva
- Warrenville Cancer Center — Warrenville
Florida
- University of Florida — Gainesville
- Mayo Clinic Jacksonville — Jacksonville
- Moffitt Cancer Center — Tampa
Alabama
- University of Alabama-Birmingham — Birmingham
- University of Alabama- Tuscaloosa — Tuscaloosa
California
- University of California - Los Angeles — Los Angeles
- University of California San Diego — San Diego
Georgia
- Morehouse School of Medicine — Atlanta
- Emory Winship Cancer Institute — Atlanta
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore
- Chesapeake Urology Associates — Towson
Connecticut
- Yale University — New Haven
Louisiana
- Tulane University — New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2032-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03151629
The ClinicalTrials.gov registry entry for NCT03151629 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prostate Cancer Clinical Trials Consortium, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which Standard of Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03151629 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Illinois, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03151629 about?
NCT03151629 is a clinical study titled "International Registry for 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...
What is the current status of trial NCT03151629?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2017-07-21. Estimated completion is 2032-01.
What conditions does trial NCT03151629 study?
This clinical trial studies the following conditions: Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03151629?
The interventions under investigation include: Standard of Care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03151629?
This trial is sponsored by Prostate Cancer Clinical Trials Consortium, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03151629 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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