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
Enrollment
106
Locations
137.4
Anticipated Duration (Months)
47.2
Patients Per Site
0.3
Patients Per Site Per Month

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, 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 three 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, every three months for the first and second year then every six months.

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. 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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1University of Alabama-BirminghamBirminghamAlabamaUnited States35233
2University of California - Los AngelesLos AngelesCaliforniaUnited States90024
3University of California San DiegoSan DiegoCaliforniaUnited States92037
4Yale UniversityNew HavenConnecticutUnited States06502
5University of FloridaGainesvilleFloridaUnited States32611
6Moffitt Cancer CenterTampaFloridaUnited States33612
7Emory Winship Cancer InstituteAtlantaGeorgiaUnited States30322
8University of Illinois at ChicagoChicagoIllinoisUnited States60607
9Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinoisUnited States60611
10University of ChicagoChicagoIllinoisUnited States60637
11Kishwaukee Cancer CenterDeKalbIllinoisUnited States60115
12Delnor Cancer CenterGenevaIllinoisUnited States60134
13Warrenville Cancer CenterWarrenvilleIllinoisUnited States60555
14Tulane UniversityNew OrleansLouisianaUnited States70118
15Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMarylandUnited States21231
16Chesapeake Urology AssociatesTowsonMarylandUnited States21204
17Dana-Farber Cancer InstituteBostonMassachusettsUnited States02215
18University of MichiganAnn ArborMichiganUnited States48109
19Karmanos Cancer InstituteDetroitMichiganUnited States48201
20University of Mississippi Medical CenterJacksonMississippiUnited States39216
21NewYork-Presbyterian Brooklyn Methodist HospitalBrooklynNew YorkUnited States11215
22Roswell Park Comprehensive Cancer CenterBuffaloNew YorkUnited States14203
23VA Western New York Healthcare SystemBuffaloNew YorkUnited States14215
24Columbia University Medical CenterNew YorkNew YorkUnited States10032
25Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
26Weill Cornell Medical CenterNew YorkNew YorkUnited States10065
27University of North Carolina at Chapel HillChapel HillNorth CarolinaUnited States27514
28Durham VA Medical CenterDurhamNorth CarolinaUnited States27705
29Duke Cancer NetworkDurhamNorth CarolinaUnited States27710
30Duke UniversityDurhamNorth CarolinaUnited States27710
31Oregon Health & Science University HospitalPortlandOregonUnited States97239
32Doylestown HealthDoylestownPennsylvaniaUnited States18901
33Thomas Jefferson UniversityPhiladelphiaPennsylvaniaUnited States19107
34Fox Chase Cancer Center - Temple HealthPhiladelphiaPennsylvaniaUnited States19134
35Reading Health SystemWest ReadingPennsylvaniaUnited States19611
36Ralph H. Johnson VA Medical CenterCharlestonSouth CarolinaUnited States29401
37William Jennings Bryan Dorn VAMCColumbiaSouth CarolinaUnited States29209
38Memphis VA Medical CenterMemphisTennesseeUnited States38104
39Baylor College of MedicineHoustonTexasUnited States77030
40University of VirginiaCharlottesvilleVirginiaUnited States22903
41University of Washington Medical CenterSeattleWashingtonUnited States98195
42University of Wisconsin Carbone Cancer CenterMadisonWisconsinUnited States53705
43Royal Brisbane & Women's HospitalHerstonBrisbaneAustralia
44St. Vincent's Hospital SydneyDarlinghurstNew South WalesAustralia
45Macquarie UniversitySydneyNew South WalesAustralia
46Westmead HospitalSydneyNew South WalesAustralia
47Redland HospitalClevelandQueenslandAustralia
48Princess Alexandra HospitalWoolloongabbaQueenslandAustralia
49Eastern Health (Box Hill Hospital)Box HillVictoriaAustralia
50Peter MacCallum Cancer CentreMelbourneVictoriaAustralia3000
51Epworth HealthcareMount WaverleyVictoriaAustralia3149
52Australian Prostate CentreMelbourne N.Australia
53Australian Urology AssociatesMelbourneAustralia
54Hospital Beneficência PortuguesaBela VistaSão PauloBrazil
55Instituto do Câncer e TransplanteCuritibaBrazil
56Centro de Pesquisa em OncologiaPorto AlegreBrazil
57Centro Paulista de OncologiaSão PauloBrazil
58Instituto Câncer do Estado de São PauloSão PauloBrazil
59Cross Cancer Institute (Alberta Health Services)EdmontonAlbertaCanadaT6G 1Z2
60BC Cancer AgencyVancouverBritish ColumbiaCanada
61Juravinski Cancer CentreHamiltonOntarioCanada
62Ottawa Hospital Cancer CentreOttawaOntarioCanada
63Princess Margaret Cancer CentreTorontoOntarioCanadaM5G 2C1
64Centre hospitalier de l'Université de Montréal (CHUM)MontréalQuebecCanada
65CHU de Québec-Université LavalQuébecQuebecCanada
66Beacon HospitalDublinLeinsterIreland
67Tallaght University HospitalDublinIrelandD24 NR0A
68St. Vincent's University HospitalDublinIreland
69Sligo University HospitalSligoIrelandF91 H684
70Federal Medical Centre AbeokutaAbeokutaNigeria
71University of Ilorin Teaching HospitalIlorinNigeria
72Lagos State University Teaching HospitalLagosNigeria
73University of Maiduguri Teaching HospitalMaiduguriNigeria
74Oslo University HospitalOsloNorway0379
75Vall d'Hebron Institute of OncologyBarcelonaCatalunyaSpain
76Institut Catalá d'Oncologia BadalonaBadalonaSpain
77Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar).BarcelonaSpain
78Hospital Clínic de BarcelonaBarcelonaSpain
79Hospital Provincial de CastellónCastellón De La PlanaSpain
80Hospital Universitario La PrincesaMadridSpain28006
81Hospital Clinico San CarlosMadridSpain
82Hospital Universitario 12 de OctubreMadridSpain
83Hospital Universitario Virgen de la VictoriaMálagaSpain
84Hospital Universitario Central de AsturiasOviedoSpain33011
85Instituto Valenciano de OncologíaValenciaSpain46009
86Skane University HospitalMalmöSkaneSweden
87Umea University HospitalUmeåSweden907 37
88Orebro University HospitalÖrebroSweden
89Universitätsspital BaselBaselSwitzerland
90Ente Ospedaliero CantonaleBellinzonaSwitzerland6500
91Kantonsspital GraubündenChurSwitzerland
92Kantonsspital St. GallenSaint GallenSwitzerland
93Universitätsspital ZürichZürichSwitzerland
94University Hospital Southampton NHS Foundation TrustSouthamptonHampshireUnited Kingdom
95Lister HospitalStevenageHertfordshireUnited KingdomSG1 4AB
96Mount Vernon Cancer CentreNorthwoodMiddlesexUnited KingdomHA6 2RN
97Velindre Cancer CentreCardiffUnited Kingdom
98University Hospitals of Morecambe Bay NHS Foundation TrustLancasterUnited Kingdom
99Guys St Thomas NHS Foundation TrustLondonUnited Kingdom
100The Royal Marsden NHS Foundation TrustLondonUnited Kingdom
101The Christie NHS Foundation TrustManchesterUnited Kingdom
102Lancashire Teaching Hospitals NHS Foundation TrustPrestonUnited KingdomPR2 9HT
103Sheffield Teaching Hospitals NHS Foundation TrustSheffieldUnited KingdomS10 2SB
104South Tyneside District HospitalSouth ShieldsUnited KingdomNE34 0PL
105Sunderland Royal HospitalSunderlandUnited KingdomSR4 7TP
106Clatterbridge Cancer CentreWirralUnited 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:
Nov 30, 2021
Last Verified:
Nov 1, 2021
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 Nov 30, 2021