International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Prostate Cancer Clinical Trial

— IRONMAN  

Official title:

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03151629
• Other study ID #: c16-170
• Status: Recruiting
• Start date: July 21, 2017
• Est. completion date: January 2029

Study information

• Verified date: May 2023
• Source: Prostate Cancer Clinical Trials Consortium
• Contact: Jacob Vinson
• Phone: 646-888-0421
• Email: pcctcironmanregistry[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.

Locations

Country	Name	City	State
Australia	Eastern Health (Box Hill Hospital)	Box Hill	Victoria
Australia	Redland Hospital	Cleveland	Queensland
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Royal Brisbane & Women's Hospital	Herston	Brisbane
Australia	Australian Urology Associates	Melbourne
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Australian Prostate Centre	Melbourne N.
Australia	Epworth Healthcare	Mount Waverley	Victoria
Australia	Macquarie University	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Barbados	The University of the West Indies - Cave Hill Campus	Bridgetown
Brazil	Hospital Beneficência Portuguesa	Bela Vista	São Paulo
Brazil	Tacchini Hospital	Bento Gonçalves	Rio Grande Do Sul
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
Canada	Cross Cancer Institute (Alberta Health Services)	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec
Canada	Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	CHU de Québec-Université Laval	Québec	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	BC Cancer Agency	Vancouver	British Columbia
Ireland	Beacon Hospital	Dublin	Leinster
Ireland	St. Vincent's University Hospital	Dublin
Ireland	Tallaght University Hospital	Dublin
Ireland	Sligo University Hospital	Sligo
Jamaica	The University of the West Indies - Mona Campus	Kingston
Kenya	University of Nairobi	Nairobi
Nigeria	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
Norway	Oslo University Hospital	Oslo
South Africa	Groote Schuur Hospital	Cape Town
South Africa	The Medical Oncology Centre of Rosebank	Johannesburg	Gauteng
South Africa	Steve Biko Academic Hospital	Pretoria	Gauteng
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	Vall d'Hebron Institute of Oncology	Barcelona	Catalunya
Spain	Hospital Provincial de Castellón	Castellón De La Plana
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Princesa	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
Sweden	Skane University Hospital	Malmö	Skane
Sweden	Orebro University Hospital	Örebro
Sweden	Umea University Hospital	Umeå
Switzerland	Universitätsspital Basel	Basel
Switzerland	Ente Ospedaliero Cantonale	Bellinzona
Switzerland	Kantonsspital Graubünden	Chur
Switzerland	Kantonsspital St. Gallen	Saint Gallen
Switzerland	Onkozentrum Zürich	Zürich
Switzerland	Universitätsspital Zürich	Zürich
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	Mount Vernon Cancer Centre	Northwood	Middlesex
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	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire
United Kingdom	Lister Hospital	Stevenage	Hertfordshire
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	Clatterbridge Cancer Centre	Wirral
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory Winship Cancer Institute	Atlanta	Georgia
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
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	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Ralph H. Johnson VA Medical Center	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Robert H. Lurie Comprehensive Cancer Center of Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	William Jennings Bryan Dorn VAMC	Columbia	South Carolina
United States	Kishwaukee Cancer Center	DeKalb	Illinois
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Doylestown Health	Doylestown	Pennsylvania
United States	Duke Cancer Network	Durham	North Carolina
United States	Duke University	Durham	North Carolina
United States	Durham VA Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Delnor Cancer Center	Geneva	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of California - Los Angeles	Los Angeles	California
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Baptist Clinical Research Institute	Memphis	Tennessee
United States	Memphis VA Medical Center	Memphis	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Tulane University	New Orleans	Louisiana
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	Fox Chase Cancer Center - Temple Health	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Oregon Health & Science University Hospital	Portland	Oregon
United States	University of California San Diego	San Diego	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	Chesapeake Urology Associates	Towson	Maryland
United States	Warrenville Cancer Center	Warrenville	Illinois
United States	Reading Health System	West Reading	Pennsylvania
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Prostate Cancer Clinical Trials Consortium

Countries where clinical trial is conducted

United States,  Australia,  Barbados,  Brazil,  Canada,  Ireland,  Jamaica,  Kenya,  Nigeria,  Norway,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Practice Patterns	To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally	5 years