Prostate Cancer Clinical Trial
— IRONMANOfficial title:
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Prostate Cancer Clinical Trials Consortium |
United States, Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom,
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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