International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Sponsor
Prostate Cancer Clinical Trials Consortium (Other)
Overall Status
Recruiting
CT.gov ID
NCT03151629
Collaborator
(none)
5,000
108
137.4
46.3
0.3

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
  • Other: Standard of Care

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Actual Study Start Date :
Jul 21, 2017
Anticipated Primary Completion Date :
Jan 1, 2029
Anticipated Study Completion Date :
Jan 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Castrate Resistant Prostate Cancer

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

Hormone Sensitive Prostate Cancer

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

Outcome Measures

Primary Outcome Measures

  1. Practice Patterns [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

• 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

  • 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
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.
Responsible Party:
Prostate Cancer Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT03151629
Other Study ID Numbers:
  • c16-170
First Posted:
May 12, 2017
Last Update Posted:
Aug 19, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022