International Registry for Men With Advanced Prostate Cancer (IRONMAN)

NCT03151629 | Recruiting

• 1 other identifier: c16-170
• Study Type: observational
• Target: 5,000
• Locations: 15 countries
• Sites: 121

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Practice Patterns

  To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally

  5 years

Study Arms (2)

Castrate Resistant Prostate Cancer

Other: Standard of Care

Hormone Sensitive Prostate Cancer

Other: Standard of Care

Interventions

Standard of Care OTHER

Drugs routinely administered for metastatic prostate cancer per local standard.

Castrate Resistant Prostate Cancer; Hormone Sensitive Prostate Cancer

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Prostate Cancer Clinical Trials Consortium: lead

Study Sites (121)

University of Alabama-Birmingham

Birmingham, Alabama, 35233, United States

COMPLETED

University of Alabama- Tuscaloosa

Tuscaloosa, Alabama, 35487, United States

RECRUITING

University of California - Los Angeles

Los Angeles, California, 90024, United States

TERMINATED

University of California San Diego

San Diego, California, 92037, United States

RECRUITING

Yale University

New Haven, Connecticut, 06502, United States

RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

TERMINATED

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

RECRUITING

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Kishwaukee Cancer Center

DeKalb, Illinois, 60115, United States

RECRUITING

Delnor Cancer Center

Geneva, Illinois, 60134, United States

RECRUITING

Warrenville Cancer Center

Warrenville, Illinois, 60555, United States

RECRUITING

Tulane University

New Orleans, Louisiana, 70118, United States

ACTIVE NOT RECRUITING

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

RECRUITING

Chesapeake Urology Associates

Towson, Maryland, 21204, United States

TERMINATED

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

TERMINATED

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

ACTIVE NOT RECRUITING

VA Western New York Healthcare System

Buffalo, New York, 14215, United States

TERMINATED

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Durham VA Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Duke Cancer Network

Durham, North Carolina, 27710, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Oregon Health & Science University Hospital

Portland, Oregon, 97239, United States

RECRUITING

Doylestown Health

Doylestown, Pennsylvania, 18901, United States

COMPLETED

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

ACTIVE NOT RECRUITING

Fox Chase Cancer Center - Temple Health

Philadelphia, Pennsylvania, 19134, United States

RECRUITING

Reading Health System

West Reading, Pennsylvania, 19611, United States

RECRUITING

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

RECRUITING

William Jennings Bryan Dorn VAMC

Columbia, South Carolina, 29209, United States

TERMINATED

Memphis VA Medical Center

Memphis, Tennessee, 38104, United States

RECRUITING

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

COMPLETED

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

ACTIVE NOT RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

RECRUITING

Royal Brisbane & Women's Hospital

Herston, Brisbane, Australia

RECRUITING

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

RECRUITING

Macquarie University

Sydney, New South Wales, Australia

RECRUITING

Westmead Hospital

Sydney, New South Wales, Australia

RECRUITING

Redland Hospital

Cleveland, Queensland, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

RECRUITING

Eastern Health (Box Hill Hospital)

Box Hill, Victoria, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Epworth Healthcare

Mount Waverley, Victoria, 3149, Australia

RECRUITING

Australian Urology Associates

Melbourne, Australia

RECRUITING

Australian Prostate Centre

Melbourne N., Australia

RECRUITING

The University of the West Indies - Cave Hill Campus

Bridgetown, Barbados

RECRUITING

Tacchini Hospital

Bento Gonçalves, Rio Grande do Sul, 95700-084, Brazil

ACTIVE NOT RECRUITING

Hospital Beneficência Portuguesa

Bela Vista, São Paulo, Brazil

TERMINATED

Instituto do Câncer e Transplante

Curitiba, Brazil

ACTIVE NOT RECRUITING

Centro de Pesquisa em Oncologia

Porto Alegre, Brazil

ACTIVE NOT RECRUITING

Centro Paulista de Oncologia

São Paulo, Brazil

ACTIVE NOT RECRUITING

Instituto Câncer do Estado de São Paulo

São Paulo, Brazil

ACTIVE NOT RECRUITING

Cross Cancer Institute (Alberta Health Services)

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

BC Cancer Agency

Vancouver, British Columbia, Canada

RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, Canada

RECRUITING

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

RECRUITING

CHU de Québec-Université Laval

Québec, Quebec, Canada

RECRUITING

Beacon Hospital

Dublin, Leinster, Ireland

RECRUITING

Tallaght University Hospital

Dublin, D24 NR0A, Ireland

RECRUITING

St. Vincent's University Hospital

Dublin, Ireland

RECRUITING

Sligo University Hospital

Sligo, F91 H684, Ireland

RECRUITING

The University of the West Indies - Mona Campus

Kingston, Jamaica

RECRUITING

University of Nairobi

Nairobi, Kenya

RECRUITING

Federal Medical Centre Abeokuta

Abeokuta, Nigeria

ACTIVE NOT RECRUITING

University of Ilorin Teaching Hospital

Ilorin, Nigeria

ACTIVE NOT RECRUITING

Lagos State University Teaching Hospital

Lagos, Nigeria

ACTIVE NOT RECRUITING

University of Maiduguri Teaching Hospital

Maiduguri, Nigeria

ACTIVE NOT RECRUITING

Oslo University Hospital

Oslo, 0379, Norway

RECRUITING

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, 2196, South Africa

ACTIVE NOT RECRUITING

Steve Biko Academic Hospital

Pretoria, Gauteng, 0084, South Africa

ACTIVE NOT RECRUITING

Groote Schuur Hospital

Cape Town, 7925, South Africa

ACTIVE NOT RECRUITING

Vall d'Hebron Institute of Oncology

Barcelona, Catalonia, Spain

ACTIVE NOT RECRUITING

Institut Catalá d'Oncologia Badalona

Badalona, Spain

ACTIVE NOT RECRUITING

Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar).

Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital Clínic de Barcelona

Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital Provincial de Castellón

Castellon, Spain

ACTIVE NOT RECRUITING

Hospital Universitario La Princesa

Madrid, 28006, Spain

ACTIVE NOT RECRUITING

Hospital Clinico San Carlos

Madrid, Spain

ACTIVE NOT RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

ACTIVE NOT RECRUITING

Instituto Valenciano de Oncología

Valencia, 46009, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Miguel Servet (Zaragoza)

Zaragoza, Spain

ACTIVE NOT RECRUITING

Skane University Hospital

Malmo, Skåne County, Sweden

RECRUITING

Orebro University Hospital

Örebro, Sweden

RECRUITING

Umea University Hospital

Umeå, 907 37, Sweden

RECRUITING

Universitätsspital Basel

Basel, Switzerland

ACTIVE NOT RECRUITING

Ente Ospedaliero Cantonale

Bellinzona, 6500, Switzerland

ACTIVE NOT RECRUITING

Kantonsspital Graubünden

Chur, Switzerland

ACTIVE NOT RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

ACTIVE NOT RECRUITING

Onkozentrum Zürich

Zurich, 8039, Switzerland

ACTIVE NOT RECRUITING

Universitätsspital Zürich

Zurich, Switzerland

ACTIVE NOT RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

RECRUITING

Lister Hospital

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

RECRUITING

Mount Vernon Cancer Centre

Northwood, Middlesex, HA6 2RN, United Kingdom

RECRUITING

Velindre Cancer Centre

Cardiff, United Kingdom

RECRUITING

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, United Kingdom

RECRUITING

Guys St Thomas NHS Foundation Trust

London, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

RECRUITING

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, PR2 9HT, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2SB, United Kingdom

RECRUITING

South Tyneside District Hospital

South Shields, NE34 0PL, United Kingdom

TERMINATED

Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

TERMINATED

Related Publications (3)

• 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.

  PMID: 38108490 DERIVED

• 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.

  PMID: 37246339 DERIVED

• 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.

  PMID: 33835826 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Daniel George, MD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

• Lorelei Mucci, ScD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Phillip Kantoff, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Vinson

CONTACT

646-888-0421; pcctcironmanregistry@mskcc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: July 21, 2017
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1); IE (4); BR (6); CA (7); CH (6); GB (13); JA (1); BA (1); SE (3); US (48); AU (11); ZA (3); ES (12); NO (1); NG (4)