International Registry for Men With Advanced Prostate Cancer (IRONMAN)
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.
Arms & interventions
- OtherStandard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Outcome measures
Primary
Practice Patterns
To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
Time frame: 5 years
Eligibility criteria
Study locations (48)
University of Alabama-Birmingham
Birmingham, Alabama, 35233
University of Alabama- Tuscaloosa
Tuscaloosa, Alabama, 35487
University of California - Los Angeles
Los Angeles, California, 90024
University of California San Diego
San Diego, California, 92037
Yale University
New Haven, Connecticut, 06502
University of Florida
Gainesville, Florida, 32611
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Moffitt Cancer Center
Tampa, Florida, 33612
Morehouse School of Medicine
Atlanta, Georgia, 30310
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
University of Illinois at Chicago
Chicago, Illinois, 60607
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Kishwaukee Cancer Center
DeKalb, Illinois, 60115
Delnor Cancer Center
Geneva, Illinois, 60134
Warrenville Cancer Center
Warrenville, Illinois, 60555
Tulane University
New Orleans, Louisiana, 70118
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Chesapeake Urology Associates
Towson, Maryland, 21204
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
University of Michigan
Ann Arbor, Michigan, 48109
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Mississippi Medical Center
Jackson, Mississippi, 39216
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
VA Western New York Healthcare System
Buffalo, New York, 14215
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical Center
New York, New York, 10065
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Durham VA Medical Center
Durham, North Carolina, 27705
Duke Cancer Network
Durham, North Carolina, 27710
Duke University
Durham, North Carolina, 27710
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Doylestown Health
Doylestown, Pennsylvania, 18901
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center - Temple Health
Philadelphia, Pennsylvania, 19134
Reading Health System
West Reading, Pennsylvania, 19611
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
William Jennings Bryan Dorn VAMC
Columbia, South Carolina, 29209
Memphis VA Medical Center
Memphis, Tennessee, 38104
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
Baylor College of Medicine
Houston, Texas, 77030
University of Virginia
Charlottesville, Virginia, 22903
University of Washington Medical Center
Seattle, Washington, 98195
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
References
- Rencsok EM, Slopen N, McManus HD, Autio KA, Morgans AK, McSwain L, Barata P, Cheng HH, Dreicer R, Gerke T, Green R, Heath EI, Howard LE, McKay RR, Nowak J, Pileggi S, Pomerantz MM, Rathkopf DE, Tagawa ST, Whang YE, Ragin C, Odedina FT, Kantoff PW, Vinson J, Villanti P, Haneuse S, Mucci LA, George DJ; IRONMAN Registry. Pain and Its Association with Survival for Black and White Individuals with Advanced Prostate Cancer in the United States. Cancer Res Commun. 2024 Jan 8;4(1):55-64. doi: 10.1158/2767-9764.CRC-23-0446.(PubMed)
- Rencsok EM, Stopsack KH, Slopen N, Odedina FT, Ragin C, Nowak J, McSwain L, Manarite J, Heath E, George DJ, Kantoff PW, Vinson J, Villanti P, Haneuse S, Mucci LA; IRONMAN Registry. Experience with the US health care system for Black and White patients with advanced prostate cancer. Cancer. 2023 Aug 15;129(16):2532-2541. doi: 10.1002/cncr.34885. Epub 2023 May 28.(PubMed)
- McKay RR, Gold T, Zarif JC, Chowdhury-Paulino IM, Friedant A, Gerke T, Grant M, Hawthorne K, Heath E, Huang FW, Jackson MD, Mahal B, Ogbeide O, Paich K, Ragin C, Rencsok EM, Simmons S, Yates C, Vinson J, Kantoff PW, George DJ, Mucci LA. Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry. JCO Glob Oncol. 2021 Apr;7:495-505. doi: 10.1200/GO.20.00571.(PubMed)