Prostate CancerIRONMANNCT03151629
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
An observational study of Prostate Cancer, run by Prostate Cancer Clinical Trials Consortium at 121 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 5,000 participants
- Where
- 121 sitesin 15 countries
- Study dates
- 21 Jul 2017to Jan 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic hormone sensitive prostate cancer (mHSPC): Prostate cancer patients diagnosed with histologically confirmed cancer with radiological evidence of metastatic disease and on ADT for no more than 90 days. Castration resistant prostate cancer (CRPC): Prostate cancer patients (with or without radiological evidence of metastatic disease) with a confirmed rising PSA (at least two measures) while on ADT or orchiectomy or castrate level of testosterone as determined by investigator. Prostate cancer patients with mixed histological types may participate in this Registry.
- 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
Trial locations and contacts
121 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
121 sites in 15 countries
United States48 sites, 35 recruiting
- Terminated
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Morehouse School of Medicine
Atlanta, Georgia, 30310
James Lillard, PhD, jlillard@msm.edu
James Lillard, PhD
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Mehmet Bilen, MD
Mehmet Bilen, MD
- Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Mark Markowski, mmarko12@jhmi.edu
- Completed
University of Alabama-Birmingham
Birmingham, Alabama, 35233
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mark Pomerantz, mark_pomerantz@dfci.harvard.edu
- Recruiting
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Scott Tagawa, MD, stt2007@med.cornell.edu
Scott Tagawa, MD
- Active, not recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
- Terminated
VA Western New York Healthcare System
Buffalo, New York, 14215
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Young Whang, young_whang@med.unc.edu
- Recruiting
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Stephen Savage, MD, savages@musc.edu
Stephen Savage, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Robert Dreicer, rd7va@hscmail.mcc.virginia.edu
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60607
Daniel Moreira, MD, moreira@uic.edu
Daniel Moreira, MD
- Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
David Vanderweele, MD, david.vanderweele@northwestern.edu
David Vanderweele, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Russell Szmulewitz, rszmulew@medicine.bsd.uchicago.edu
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Pedro Barata, MD, pedro.barata@uhhospitals.org
Pedro Barata, MD
- Terminated
William Jennings Bryan Dorn VAMC
Columbia, South Carolina, 29209
- Recruiting
Kishwaukee Cancer Center
DeKalb, Illinois, 60115
Christopher George, MD, christopher.george@nm.org
Christopher George, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Frank Cackowski, MD, cackowskif@karmanos.org
- Completed
Doylestown Health
Doylestown, Pennsylvania, 18901
- Recruiting
Durham VA Medical Center
Durham, North Carolina, 27705
Rhonda Bitting, MD, Rhonda.Bitting@va.gov
Rhonda Bitting, MD
- Recruiting
Duke Cancer Network
Durham, North Carolina, 27710
Tian Zhang, MD
Tian Zhang, MD
- Recruiting
Duke University
Durham, North Carolina, 27710
Dan George, daniel.george@duke.edu
- Terminated
University of Florida
Gainesville, Florida, 32611
- Recruiting
Delnor Cancer Center
Geneva, Illinois, 60134
Christopher George, MD, christopher.george@nm.org
Christopher George, MD
- Completed
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
John Henegan, MD, jhenegan@umc.edu
John Henegan, MD
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Folakemi Odedina, PhD, Odedina.Folakemi@mayo.edu
Folakemi Odedina, PhD
- Terminated
University of California - Los Angeles
Los Angeles, California, 90024
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
Hamid Emamekhoo, MD
Hamid Emamekhoo, MD
- Recruiting
Memphis VA Medical Center
Memphis, Tennessee, 38104
Alva Weir, MD, Alva.weir@va.gov
- Recruiting
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
Osarenren Ogbeide, MD, osa.ogbeide@bmg.md
Osarenren Ogbeide, MD
- Recruiting
Yale University
New Haven, Connecticut, 06502
Daniel Petrylak, MD, daniel.petrylak@yale.edu
Daniel Petrylak, MD
- Active, not recruiting
Tulane University
New Orleans, Louisiana, 70118
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Mark Stein, MD
Mark Stein, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Karen Autio, MD, autiok@mskcc.org
- Recruiting
Weill Cornell Medical Center
New York, New York, 10065
Scott Tagawa, MD
Scott Tagawa, MD
- Active, not recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
Fox Chase Cancer Center - Temple Health
Philadelphia, Pennsylvania, 19134
Camille Ragin, PhD, Camille.Ragin@fccc.edu
Camille Ragin, PhD
- Recruiting
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Alexandra Sokolova, sokolova@ohsu.edu
Sokolova
- Recruiting
University of California San Diego
San Diego, California, 92037
Rana McKay, MD
Rana McKay, MD
- Active, not recruiting
University of Washington Medical Center
Seattle, Washington, 98195
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Monica Chatwal, MD, Monica.chatwal@moffitt.org
- Terminated
Chesapeake Urology Associates
Towson, Maryland, 21204
- Recruiting
University of Alabama- Tuscaloosa
Tuscaloosa, Alabama, 35487
Camille Ragin, camille.ragin@fccc.edu
Camille Ragin, PhD
- Recruiting
Warrenville Cancer Center
Warrenville, Illinois, 60555
Christopher George, MD, christopher.george@nm.org
Christopher George, MD
- Recruiting
Reading Health System
West Reading, Pennsylvania, 19611
Terrence Cescon, MD, Terrence.cescon@towerhealth.org
Terrence Cescon, MD
- Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Kriti Mittal, MD
Kriti Mittal, MD
United Kingdom13 sites, 11 recruiting
- Recruiting
Velindre Cancer Centre
Cardiff
Jacob Tanguay, MD, Jacob.Tanguay@wales.nhs.uk
Jacob Tanguay, MD
- Recruiting
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster
Alison Birtle, MD, Alison.Birtle@mbht.nhs.uk
Alison Birtle, MD
- Recruiting
Guys St Thomas NHS Foundation Trust
London
Harriet Wylie, harriet.wylie@kcl.ac.uk
Deborah Enting
- Recruiting
The Royal Marsden NHS Foundation Trust
London
Vincent Khoo, vincent.khoo@rmh.nhs.uk
Vincent Khoo, MD
- Recruiting
The Christie NHS Foundation Trust
Manchester
Ananya Choudhury, Ananya.Choudhury@christie.nhs.uk
- Recruiting
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral
Isabel Syndikus, MD, isabel.syndikus@nhs.net
Isabel Syndikus, MD
- Recruiting
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN
Anand Sharma, MD, anand.sharma3@nhs.net
Anand Sharma, MD
- Recruiting
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT
Alison Birtle, MD, Alison.Birtle@lthtr.nhs.uk
Alison Birtle, MD
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SB
Carmel Pezaro, MD, carmel.pezaro@nhs.net
Carmel Pezaro, MD
- Terminated
South Tyneside District Hospital
South Shields, NE34 0PL
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire
Simon Crabb, MD, simon.crabb@uhs.nhs.uk
Simon Crabb, MD
- Recruiting
Lister Hospital
Stevenage, Hertfordshire, SG1 4AB
Anand Sharma, MD, anand.sharma3@nhs.net
Anand Sharma, MD
- Terminated
Sunderland Royal Hospital
Sunderland, SR4 7TP
Spain12 sites
- Active, not recruiting
Institut Catalá d'Oncologia Badalona
Badalona
- Active, not recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona
- Active, not recruiting
Vall d'Hebron Institute of Oncology
Barcelona, Catalonia
- Active, not recruiting
Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar).
Barcelona
- Active, not recruiting
Hospital Provincial de Castellón
Castellon
- Active, not recruiting
Hospital Universitario La Princesa
Madrid, 28006
- Active, not recruiting
Hospital Clinico San Carlos
Madrid
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid
- Active, not recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Málaga
- Active, not recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
- Active, not recruiting
Instituto Valenciano de Oncología
Valencia, Valencia, 46009
- Active, not recruiting
Hospital Universitario Miguel Servet (Zaragoza)
Zaragoza
Australia11 sites, 11 recruiting
- Recruiting
Eastern Health (Box Hill Hospital)
Box Hill, Victoria
Ian Davis
Ian Davis
- Recruiting
Redland Hospital
Cleveland, Queensland
Ian Vela
Ian Vela
- Recruiting
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales
Anthony Joshua, MD, Anthony.Joshua@svha.org.au
Anthony Joshua, MD
- Recruiting
Royal Brisbane & Women's Hospital
Herston, Brisbane
Ian D Davis, MD, Ian.davis@monash.edu
Ian D Davis, MD
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Declan Murphy, MD, Declan.Murphy@petermac.org
Declan Murphy
- Recruiting
Australian Urology Associates
Melbourne
Mark Frydenberg
Mark Frydenberg
- Recruiting
Australian Prostate Centre
Melbourne N.
Philip Dundee, MD, phildundee@gmail.com
Philip Dundee, MD
- Recruiting
Epworth Healthcare
Mount Waverley, Victoria, 3149
Ben Tran, MD, ben.tran@petermac.org
Ben Tran, MD
- Recruiting
Macquarie University
Sydney, New South Wales
Howard Gurney
Howard Gurney
- Recruiting
Westmead Hospital
Sydney, New South Wales
Howard Gurney
Howard Gurney
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland
Ian Vela
Ian Vela
Canada7 sites, 7 recruiting
- Recruiting
Cross Cancer Institute (Alberta Health Services)
Edmonton, Alberta, T6G 1Z2
Michael Kolinsky, MD, Michael.Kolinsky@ahs.ca
Michael Kolinsky, MD
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario
Sebastian Hotte
Sebastian Hotte
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Fred Saad
Fred Saad
- Recruiting
Ottawa Hospital Cancer Centre
Ottawa, Ontario
Michael Ong
Michael Ong
- Recruiting
CHU de Québec-Université Laval
Québec, Quebec
Frederic Pouliot
Frederic Pouliot
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
Antonio Finelli, MD, Antonio.finelli@uhn.ca
Antonio Finelli, MD
- Recruiting
BC Cancer Agency
Vancouver, British Columbia
Kim Chi
Kim Chi
Brazil6 sites
- Terminated
Hospital Beneficência Portuguesa
Bela Vista, São Paulo
- Active, not recruiting
Tacchini Hospital
Bento Gonçalves, Rio Grande do Sul, 95700-084
- Completed
Instituto do Câncer e Transplante
Curitiba
- Active, not recruiting
Centro de Pesquisa em Oncologia
Porto Alegre
- Completed
Centro Paulista de Oncologia
São Paulo
- Completed
Instituto Câncer do Estado de São Paulo
São Paulo
Switzerland6 sites
- Active, not recruiting
Universitätsspital Basel
Basel
- Active, not recruiting
Ente Ospedaliero Cantonale
Bellinzona, Bellinzona, 6500
- Active, not recruiting
Kantonsspital Graubünden
Chur
- Active, not recruiting
Kantonsspital St. Gallen
Sankt Gallen
- Active, not recruiting
Onkozentrum Zürich
Zurich, 8039
- Active, not recruiting
Universitätsspital Zürich
Zurich
Ireland4 sites, 4 recruiting
- Recruiting
Beacon Hospital
Dublin, Leinster
Ray McDermott
Ray McDermott
- Recruiting
Tallaght University Hospital
Dublin, D24 NR0A
Ray McDermott, MD, Ray.McDermott@tuh.ie
Ray McDermott, MD
- Recruiting
St. Vincent's University Hospital
Dublin
Ray McDermott, MD, Ray.McDermott@tuh.ie
Ray McDermott, MD
- Recruiting
Sligo University Hospital
Sligo, F91 H684
Ala Yousif, MD, Ala.yousif@hse.ie
Ala Yousif, MD
Nigeria4 sites
- Active, not recruiting
Federal Medical Centre Abeokuta
Abeokuta
- Active, not recruiting
University of Ilorin Teaching Hospital
Ilorin
- Active, not recruiting
Lagos State University Teaching Hospital
Lagos
- Active, not recruiting
University of Maiduguri Teaching Hospital
Maiduguri
South Africa3 sites
- Active, not recruiting
Groote Schuur Hospital
Cape Town, 7925
- Active, not recruiting
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196
- Active, not recruiting
Steve Biko Academic Hospital
Pretoria, Gauteng, 0084
Sweden3 sites, 3 recruiting
- Recruiting
Skane University Hospital
Malmö, Skåne County
Anders Bjartell
Anders Bjartell
- Recruiting
Orebro University Hospital
Örebro
Janus Frey, janusz.frey@regionorebrolan.se;
- Recruiting
Umea University Hospital
Umeå, Sweden, 907 37
Camilla karlsson, MD, camilla.thellenberg@umu.se
Camilla karlsson, MD
Barbados1 site, 1 recruiting
- Recruiting
The University of the West Indies - Cave Hill Campus
Bridgetown
Simon Anderson, MBBCh, simon.anderson@cavehill.uwi.edu
Simon Anderson, MBBCh
Jamaica1 site, 1 recruiting
- Recruiting
The University of the West Indies - Mona Campus
Kingston
Simone Badal, PhD, simone.badal@uwimona.edu.jm
Simone Badal, PhD
Kenya1 site, 1 recruiting
- Recruiting
University of Nairobi
Nairobi
Charles G Waihenya, MBChB, charleswaihenya@uonbi.ac.ke
Charles G Waihenya, MBChB
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0379
Kjell Russnes, MD, KMF@ous-hf.no
Kjell Russnes, MD
About this study
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.
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- Standard of Care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Drugs routinely administered for metastatic prostate cancer per local standard.
| Study group | Role | What they receive |
|---|---|---|
| Castrate Resistant Prostate Cancer | Not described Receives: Other: Standard of Care | |
| Hormone Sensitive Prostate Cancer | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practice Patterns
To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start21 Jul 2017
- Primary completionJan 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Prostate Cancer Clinical Trials Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel George, MD, Principal investigator, Duke Cancer InstituteLorelei Mucci, ScD, Principal investigator, Harvard School of Public Health (HSPH)Phillip Kantoff, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151629
- Sponsor's protocol ID
- c16-170
- Acronym
- IRONMAN
- Status last verified
- May 2026
- First submitted
- 10 May 2017
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 38108490Rencsok 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 37246339McKay 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 33835826
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry for Men With Advanced Prostate Cancer (IRONMAN)
- ClinicalTrials.gov ID
- NCT03151629
- Acronym / sponsor ID
- IRONMAN / c16-170
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Prostate Cancer Clinical Trials ConsortiumUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Castrate Resistant Prostate Cancer | – | Other: Standard of Care |
| Hormone Sensitive Prostate Cancer | – | Other: Standard of Care |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic hormone sensitive prostate cancer (mHSPC): Prostate cancer patients diagnosed with histologically confirmed cancer with radiological evidence of metastatic disease and on ADT for no more than 90 days. Castration resistant prostate cancer (CRPC): Prostate cancer patients (with or without radiological evidence of metastatic disease) with a confirmed rising PSA (at least two measures) while on ADT or orchiectomy or castrate level of testosterone as determined by investigator. Prostate cancer patients with mixed histological types may participate in this Registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareDrugs routinely administered for metastatic prostate cancer per local standard. | Other | Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer |
Primary outcome
Practice Patterns
Time frame: 5 years
To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 38108490Rencsok 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.
- Derived from this study: PubMed 37246339Rencsok 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.
- Derived from this study: PubMed 33835826McKay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel George, MD principal investigator
Duke Cancer Institute
Lorelei Mucci, ScD principal investigator
Harvard School of Public Health (HSPH)
Phillip Kantoff, MD principal investigator
Memorial Sloan Kettering Cancer Center
121 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Prostate Cancer Clinical Trials Consortium at 121 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in United States, United Kingdom, Spain, Australia, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Vinson (646-888-0421, pcctcironmanregistry@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practice Patterns (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151629, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.