International Registry for Men With Advanced Prostate Cancer (IRONMAN)
NCT ID: NCT03151629
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2017-07-21
2032-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Castrate Resistant Prostate Cancer
Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Hormone Sensitive Prostate Cancer
Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Interventions
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Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Eligibility Criteria
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Inclusion Criteria
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
21 Years
MALE
No
Sponsors
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Prostate Cancer Clinical Trials Consortium
OTHER
Responsible Party
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Principal Investigators
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Daniel George, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Cancer Institute
Lorelei Mucci, ScD
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Phillip Kantoff, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of Alabama-Birmingham
Birmingham, Alabama, United States
University of Alabama- Tuscaloosa
Tuscaloosa, Alabama, United States
University of California - Los Angeles
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Kishwaukee Cancer Center
DeKalb, Illinois, United States
Delnor Cancer Center
Geneva, Illinois, United States
Warrenville Cancer Center
Warrenville, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Chesapeake Urology Associates
Towson, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
VA Western New York Healthcare System
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Durham VA Medical Center
Durham, North Carolina, United States
Duke Cancer Network
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Doylestown Health
Doylestown, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Temple Health
Philadelphia, Pennsylvania, United States
Reading Health System
West Reading, Pennsylvania, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States
William Jennings Bryan Dorn VAMC
Columbia, South Carolina, United States
Memphis VA Medical Center
Memphis, Tennessee, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Royal Brisbane & Women's Hospital
Herston, Brisbane, Australia
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Macquarie University
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Redland Hospital
Cleveland, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Eastern Health (Box Hill Hospital)
Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Epworth Healthcare
Mount Waverley, Victoria, Australia
Australian Urology Associates
Melbourne, , Australia
Australian Prostate Centre
Melbourne N., , Australia
The University of the West Indies - Cave Hill Campus
Bridgetown, , Barbados
Tacchini Hospital
Bento Gonçalves, Rio Grande do Sul, Brazil
Hospital Beneficência Portuguesa
Bela Vista, São Paulo, Brazil
Instituto do Câncer e Transplante
Curitiba, , Brazil
Centro de Pesquisa em Oncologia
Porto Alegre, , Brazil
Centro Paulista de Oncologia
São Paulo, , Brazil
Instituto Câncer do Estado de São Paulo
São Paulo, , Brazil
Cross Cancer Institute (Alberta Health Services)
Edmonton, Alberta, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
CHU de Québec-Université Laval
Québec, Quebec, Canada
Beacon Hospital
Dublin, Leinster, Ireland
Tallaght University Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Sligo University Hospital
Sligo, , Ireland
The University of the West Indies - Mona Campus
Kingston, , Jamaica
University of Nairobi
Nairobi, , Kenya
Federal Medical Centre Abeokuta
Abeokuta, , Nigeria
University of Ilorin Teaching Hospital
Ilorin, , Nigeria
Lagos State University Teaching Hospital
Lagos, , Nigeria
University of Maiduguri Teaching Hospital
Maiduguri, , Nigeria
Oslo University Hospital
Oslo, , Norway
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital
Pretoria, Gauteng, South Africa
Groote Schuur Hospital
Cape Town, , South Africa
Vall d'Hebron Institute of Oncology
Barcelona, Catalonia, Spain
Institut Catalá d'Oncologia Badalona
Badalona, , Spain
Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar).
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Provincial de Castellón
Castellon, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Universitario Miguel Servet (Zaragoza)
Zaragoza, , Spain
Skane University Hospital
Malmo, Skåne County, Sweden
Orebro University Hospital
Örebro, , Sweden
Umea University Hospital
Umeå, , Sweden
Universitätsspital Basel
Basel, , Switzerland
Ente Ospedaliero Cantonale
Bellinzona, , Switzerland
Kantonsspital Graubünden
Chur, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Onkozentrum Zürich
Zurich, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Lister Hospital
Stevenage, Hertfordshire, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, , United Kingdom
Guys St Thomas NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
South Tyneside District Hospital
South Shields, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Rana McKay, MD
Role: primary
Mehmet Bilen, MD
Role: primary
Kriti Mittal, MD
Role: primary
Mark Stein, MD
Role: primary
Scott Tagawa, MD
Role: primary
Tian Zhang, MD
Role: primary
Hamid Emamekhoo, MD
Role: primary
Howard Gurney
Role: primary
Howard Gurney
Role: primary
Ian Vela
Role: primary
Ian Vela
Role: primary
Ian Davis
Role: primary
Mark Frydenberg
Role: primary
Kim Chi
Role: primary
Sebastian Hotte
Role: primary
Michael Ong
Role: primary
Fred Saad
Role: primary
Frederic Pouliot
Role: primary
Ray McDermott
Role: primary
Anders Bjartell
Role: primary
References
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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.
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.
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.
Other Identifiers
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c16-170
Identifier Type: -
Identifier Source: org_study_id
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