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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03151629




Registration number
NCT03151629
Ethics application status
Date submitted
10/05/2017
Date registered
12/05/2017
Date last updated
6/05/2023

Titles & IDs
Public title
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Scientific title
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Secondary ID [1] 0 0
c16-170
Universal Trial Number (UTN)
Trial acronym
IRONMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Standard of Care

Castrate Resistant Prostate Cancer -

Hormone Sensitive Prostate Cancer -


Other interventions: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Practice Patterns
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion 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.

* 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
Minimum age
21 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
BrisbaneNSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Macquarie University - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Sydney
Recruitment hospital [5] 0 0
Redland Hospital - Cleveland
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Eastern Health (Box Hill Hospital) - Box Hill
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [9] 0 0
Epworth Healthcare - Mount Waverley
Recruitment hospital [10] 0 0
Australian Prostate Centre - Melbourne N.
Recruitment hospital [11] 0 0
Australian Urology Associates - Melbourne
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Cleveland
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
3000 - Melbourne
Recruitment postcode(s) [8] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [9] 0 0
- Melbourne N.
Recruitment postcode(s) [10] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Barbados
State/province [22] 0 0
Bridgetown
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio Grande Do Sul
Country [24] 0 0
Brazil
State/province [24] 0 0
São Paulo
Country [25] 0 0
Brazil
State/province [25] 0 0
Curitiba
Country [26] 0 0
Brazil
State/province [26] 0 0
Porto Alegre
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Ireland
State/province [31] 0 0
Leinster
Country [32] 0 0
Ireland
State/province [32] 0 0
Dublin
Country [33] 0 0
Ireland
State/province [33] 0 0
Sligo
Country [34] 0 0
Jamaica
State/province [34] 0 0
Kingston
Country [35] 0 0
Kenya
State/province [35] 0 0
Nairobi
Country [36] 0 0
Nigeria
State/province [36] 0 0
Abeokuta
Country [37] 0 0
Nigeria
State/province [37] 0 0
Ilorin
Country [38] 0 0
Nigeria
State/province [38] 0 0
Lagos
Country [39] 0 0
Nigeria
State/province [39] 0 0
Maiduguri
Country [40] 0 0
Norway
State/province [40] 0 0
Oslo
Country [41] 0 0
South Africa
State/province [41] 0 0
Gauteng
Country [42] 0 0
South Africa
State/province [42] 0 0
Cape Town
Country [43] 0 0
Spain
State/province [43] 0 0
Catalunya
Country [44] 0 0
Spain
State/province [44] 0 0
Badalona
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Castellón De La Plana
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Málaga
Country [49] 0 0
Spain
State/province [49] 0 0
Oviedo
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
Spain
State/province [51] 0 0
Zaragoza
Country [52] 0 0
Sweden
State/province [52] 0 0
Skane
Country [53] 0 0
Sweden
State/province [53] 0 0
Umeå
Country [54] 0 0
Sweden
State/province [54] 0 0
Örebro
Country [55] 0 0
Switzerland
State/province [55] 0 0
Basel
Country [56] 0 0
Switzerland
State/province [56] 0 0
Bellinzona
Country [57] 0 0
Switzerland
State/province [57] 0 0
Chur
Country [58] 0 0
Switzerland
State/province [58] 0 0
Saint Gallen
Country [59] 0 0
Switzerland
State/province [59] 0 0
Zürich
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Hampshire
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Hertfordshire
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Middlesex
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Cardiff
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Lancaster
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Manchester
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Preston
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Sheffield
Country [69] 0 0
United Kingdom
State/province [69] 0 0
South Shields
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Sunderland
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Other
Name
Prostate Cancer Clinical Trials Consortium
Address
Country

Ethics approval
Ethics application status

Summary
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, 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.
Trial website
https://clinicaltrials.gov/study/NCT03151629
Trial related presentations / publications
McKay RR, Gold T, Zarif JC, Chowdhury-Paulino IM, Friedant A, Gerke T, Grant M, Hawthorne K, Heath E, Huang FW, Jackson MD, Mahal B, Ogbeide O, Paich K, Ragin C, Rencsok EM, Simmons S, Yates C, Vinson J, Kantoff PW, George DJ, Mucci LA. Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry. JCO Glob Oncol. 2021 Apr;7:495-505. doi: 10.1200/GO.20.00571.
Public notes

Contacts
Principal investigator
Name 0 0
Daniel George, MD
Address 0 0
Duke Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jacob Vinson
Address 0 0
Country 0 0
Phone 0 0
646-888-0421
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03151629