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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

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
1/01/2032
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
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United States of America
State/province [2] 0 0
California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Mississippi
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Barbados
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Bridgetown
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Curitiba
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Brazil
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Porto Alegre
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Quebec
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Leinster
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Dublin
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Ireland
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Sligo
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Jamaica
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Kingston
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Kenya
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Nairobi
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Nigeria
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Abeokuta
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Nigeria
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Ilorin
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Nigeria
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Lagos
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Nigeria
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Maiduguri
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Norway
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Oslo
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South Africa
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Gauteng
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South Africa
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Cape Town
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Spain
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Catalunya
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Castellón De La Plana
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Oviedo
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Skane
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Sweden
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Umeå
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Sweden
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Örebro
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Switzerland
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Basel
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Switzerland
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Bellinzona
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Switzerland
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Chur
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Switzerland
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Saint Gallen
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Switzerland
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Zürich
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United Kingdom
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Hampshire
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Hertfordshire
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Middlesex
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Cardiff
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Lancaster
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London
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Manchester
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Preston
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Sheffield
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United Kingdom
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South Shields
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United Kingdom
State/province [71] 0 0
Sunderland
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United Kingdom
State/province [72] 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
Trial website
Trial related presentations / publications
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
pcctcironmanregistry@mskcc.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03151629