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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)
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Scientific title
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
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Secondary ID [1]
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c16-170
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Universal Trial Number (UTN)
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Trial acronym
IRONMAN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Practice Patterns
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Assessment method [1]
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To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
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Timepoint [1]
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5 years
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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
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Minimum age
21
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2029
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
BrisbaneNSW,QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane & Women's Hospital - Herston
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St. Vincent's Hospital Sydney - Darlinghurst
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Macquarie University - Sydney
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Westmead Hospital - Sydney
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Redland Hospital - Cleveland
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Princess Alexandra Hospital - Woolloongabba
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Eastern Health (Box Hill Hospital) - Box Hill
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Peter MacCallum Cancer Centre - Melbourne
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Epworth Healthcare - Mount Waverley
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Recruitment hospital [10]
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Australian Prostate Centre - Melbourne N.
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Recruitment hospital [11]
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Australian Urology Associates - Melbourne
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- Herston
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- Darlinghurst
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- Sydney
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- Cleveland
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- Woolloongabba
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- Box Hill
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3000 - Melbourne
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3149 - Mount Waverley
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- Melbourne N.
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Prostate Cancer Clinical Trials Consortium
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03151629
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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.
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Public notes
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Contacts
Principal investigator
Name
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Daniel George, MD
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Address
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Duke Cancer Institute
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Contact person for public queries
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Jacob Vinson
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646-888-0421
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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