International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Study Details
Study Description
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, Brazil, Canada, Ireland, Jamaica, Nigeria, Norway, Spain, Sweden, Switzerland, the United Kingdom (UK), and the 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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Castrate Resistant Prostate Cancer
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Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
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Hormone Sensitive Prostate Cancer
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Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
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Outcome Measures
Primary Outcome Measures
- Practice Patterns [5 years]
To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
Eligibility Criteria
Criteria
• 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.
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Males 21 years of age and above
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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
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama-Birmingham | Birmingham | Alabama | United States | 35233 |
2 | University of California - Los Angeles | Los Angeles | California | United States | 90024 |
3 | University of California San Diego | San Diego | California | United States | 92037 |
4 | Yale University | New Haven | Connecticut | United States | 06502 |
5 | University of Florida | Gainesville | Florida | United States | 32611 |
6 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
7 | Emory Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
8 | University of Illinois at Chicago | Chicago | Illinois | United States | 60607 |
9 | Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | United States | 60611 |
10 | University of Chicago | Chicago | Illinois | United States | 60637 |
11 | Kishwaukee Cancer Center | DeKalb | Illinois | United States | 60115 |
12 | Delnor Cancer Center | Geneva | Illinois | United States | 60134 |
13 | Warrenville Cancer Center | Warrenville | Illinois | United States | 60555 |
14 | Tulane University | New Orleans | Louisiana | United States | 70118 |
15 | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | United States | 21231 |
16 | Chesapeake Urology Associates | Towson | Maryland | United States | 21204 |
17 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
18 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
19 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
20 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
21 | NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | United States | 11215 |
22 | Roswell Park Comprehensive Cancer Center | Buffalo | New York | United States | 14203 |
23 | VA Western New York Healthcare System | Buffalo | New York | United States | 14215 |
24 | Columbia University Medical Center | New York | New York | United States | 10032 |
25 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
26 | Weill Cornell Medical Center | New York | New York | United States | 10065 |
27 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27514 |
28 | Durham VA Medical Center | Durham | North Carolina | United States | 27705 |
29 | Duke Cancer Network | Durham | North Carolina | United States | 27710 |
30 | Duke University | Durham | North Carolina | United States | 27710 |
31 | Oregon Health & Science University Hospital | Portland | Oregon | United States | 97239 |
32 | Doylestown Health | Doylestown | Pennsylvania | United States | 18901 |
33 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
34 | Fox Chase Cancer Center - Temple Health | Philadelphia | Pennsylvania | United States | 19134 |
35 | Reading Health System | West Reading | Pennsylvania | United States | 19611 |
36 | Ralph H. Johnson VA Medical Center | Charleston | South Carolina | United States | 29401 |
37 | William Jennings Bryan Dorn VAMC | Columbia | South Carolina | United States | 29209 |
38 | Memphis VA Medical Center | Memphis | Tennessee | United States | 38104 |
39 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
40 | University of Virginia | Charlottesville | Virginia | United States | 22903 |
41 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
42 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53705 |
43 | Royal Brisbane & Women's Hospital | Herston | Brisbane | Australia | |
44 | St. Vincent's Hospital Sydney | Darlinghurst | New South Wales | Australia | |
45 | Macquarie University | Sydney | New South Wales | Australia | |
46 | Westmead Hospital | Sydney | New South Wales | Australia | |
47 | Redland Hospital | Cleveland | Queensland | Australia | |
48 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | |
49 | Eastern Health (Box Hill Hospital) | Box Hill | Victoria | Australia | |
50 | Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia | 3000 |
51 | Epworth Healthcare | Mount Waverley | Victoria | Australia | 3149 |
52 | Australian Prostate Centre | Melbourne N. | Australia | ||
53 | Australian Urology Associates | Melbourne | Australia | ||
54 | Hospital Beneficência Portuguesa | Bela Vista | São Paulo | Brazil | |
55 | Instituto do Câncer e Transplante | Curitiba | Brazil | ||
56 | Centro de Pesquisa em Oncologia | Porto Alegre | Brazil | ||
57 | Centro Paulista de Oncologia | São Paulo | Brazil | ||
58 | Instituto Câncer do Estado de São Paulo | São Paulo | Brazil | ||
59 | Cross Cancer Institute (Alberta Health Services) | Edmonton | Alberta | Canada | T6G 1Z2 |
60 | BC Cancer Agency | Vancouver | British Columbia | Canada | |
61 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | |
62 | Ottawa Hospital Cancer Centre | Ottawa | Ontario | Canada | |
63 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2C1 |
64 | Centre hospitalier de l'Université de Montréal (CHUM) | Montréal | Quebec | Canada | |
65 | CHU de Québec-Université Laval | Québec | Quebec | Canada | |
66 | Beacon Hospital | Dublin | Leinster | Ireland | |
67 | Tallaght University Hospital | Dublin | Ireland | D24 NR0A | |
68 | St. Vincent's University Hospital | Dublin | Ireland | ||
69 | Sligo University Hospital | Sligo | Ireland | F91 H684 | |
70 | Federal Medical Centre Abeokuta | Abeokuta | Nigeria | ||
71 | University of Ilorin Teaching Hospital | Ilorin | Nigeria | ||
72 | Lagos State University Teaching Hospital | Lagos | Nigeria | ||
73 | University of Maiduguri Teaching Hospital | Maiduguri | Nigeria | ||
74 | Oslo University Hospital | Oslo | Norway | 0379 | |
75 | Vall d'Hebron Institute of Oncology | Barcelona | Catalunya | Spain | |
76 | Institut Catalá d'Oncologia Badalona | Badalona | Spain | ||
77 | Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar). | Barcelona | Spain | ||
78 | Hospital Clínic de Barcelona | Barcelona | Spain | ||
79 | Hospital Provincial de Castellón | Castellón De La Plana | Spain | ||
80 | Hospital Universitario La Princesa | Madrid | Spain | 28006 | |
81 | Hospital Clinico San Carlos | Madrid | Spain | ||
82 | Hospital Universitario 12 de Octubre | Madrid | Spain | ||
83 | Hospital Universitario Virgen de la Victoria | Málaga | Spain | ||
84 | Hospital Universitario Central de Asturias | Oviedo | Spain | 33011 | |
85 | Instituto Valenciano de Oncología | Valencia | Spain | 46009 | |
86 | Hospital Universitario Miguel Servet (Zaragoza) | Zaragoza | Spain | ||
87 | Skane University Hospital | Malmö | Skane | Sweden | |
88 | Umea University Hospital | Umeå | Sweden | 907 37 | |
89 | Orebro University Hospital | Örebro | Sweden | ||
90 | Universitätsspital Basel | Basel | Switzerland | ||
91 | Ente Ospedaliero Cantonale | Bellinzona | Switzerland | 6500 | |
92 | Kantonsspital Graubünden | Chur | Switzerland | ||
93 | Kantonsspital St. Gallen | Saint Gallen | Switzerland | ||
94 | Onkozentrum Zürich | Zürich | Switzerland | 8039 | |
95 | Universitätsspital Zürich | Zürich | Switzerland | ||
96 | University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire | United Kingdom | |
97 | Lister Hospital | Stevenage | Hertfordshire | United Kingdom | SG1 4AB |
98 | Mount Vernon Cancer Centre | Northwood | Middlesex | United Kingdom | HA6 2RN |
99 | Velindre Cancer Centre | Cardiff | United Kingdom | ||
100 | University Hospitals of Morecambe Bay NHS Foundation Trust | Lancaster | United Kingdom | ||
101 | Guys St Thomas NHS Foundation Trust | London | United Kingdom | ||
102 | The Royal Marsden NHS Foundation Trust | London | United Kingdom | ||
103 | The Christie NHS Foundation Trust | Manchester | United Kingdom | ||
104 | Lancashire Teaching Hospitals NHS Foundation Trust | Preston | United Kingdom | PR2 9HT | |
105 | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | United Kingdom | S10 2SB | |
106 | South Tyneside District Hospital | South Shields | United Kingdom | NE34 0PL | |
107 | Sunderland Royal Hospital | Sunderland | United Kingdom | SR4 7TP | |
108 | Clatterbridge Cancer Centre | Wirral | United Kingdom |
Sponsors and Collaborators
- Prostate Cancer Clinical Trials Consortium
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- c16-170