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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03151629
Other study ID # c16-170
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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