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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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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Wirral
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Funding & Sponsors
Primary sponsor type
Other
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Name
Prostate Cancer Clinical Trials Consortium
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Address
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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/ct2/show/NCT03151629
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Trial related presentations / publications
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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 protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03151629
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