International Registry for Men With Advanced Prostate Cancer (IRONMAN) (NCT03151629)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: University of Alabama-Birmingham โ Birmingham, Alabama
Age range: 21 Years
๐งช Interventions in This Study
- Standard of Care (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (121 Sites)
Showing the first 25 of 121 sites.
- University of Alabama-Birmingham โ Birmingham, Alabama
- University of Alabama- Tuscaloosa โ Tuscaloosa, Alabama
- University of California - Los Angeles โ Los Angeles, California
- University of California San Diego โ San Diego, California
- Yale University โ New Haven, Connecticut
- University of Florida โ Gainesville, Florida
- Mayo Clinic Jacksonville โ Jacksonville, Florida
- Moffitt Cancer Center โ Tampa, Florida
- Morehouse School of Medicine โ Atlanta, Georgia
- Emory Winship Cancer Institute โ Atlanta, Georgia
- University of Illinois at Chicago โ Chicago, Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University โ Chicago, Illinois
- University of Chicago โ Chicago, Illinois
- Kishwaukee Cancer Center โ DeKalb, Illinois
- Delnor Cancer Center โ Geneva, Illinois
- Warrenville Cancer Center โ Warrenville, Illinois
- Tulane University โ New Orleans, Louisiana
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center โ Baltimore, Maryland
- Chesapeake Urology Associates โ Towson, Maryland
- Dana-Farber Cancer Institute โ Boston, Massachusetts
- University of Massachusetts Memorial Medical Center โ Worcester, Massachusetts
- University of Michigan โ Ann Arbor, Michigan
- Karmanos Cancer Institute โ Detroit, Michigan
- University of Mississippi Medical Center โ Jackson, Mississippi
- NewYork-Presbyterian Brooklyn Methodist Hospital โ Brooklyn, New York
๐ Contact the Study Coordinator
Phone: (646) 888-0421
Email: pcctcironmanregistry@mskcc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prostate Cancer
- A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC โ Homewood, Alabama
- A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described โ Homewood, Alabama
- Stereotactic Ablative Radiation Therapy for Prostate Cancer โ Charleston, South Carolina
- A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer โ Basking Ridge, New Jersey
- A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer โ Phoenix, Arizona
- Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer โ Baltimore, Maryland
Explore by condition: All Prostate Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.