Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/15/2018
Start Date:May 1, 2017
End Date:June 2024
Contact:Jacob Vinson
Email:pcctcironmanregistry@mskcc.org
Phone:646-888-0421

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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.


• 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
We found this trial at
13
sites
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Principal Investigator: Shilajit Kundu, MD
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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Chicago, IL
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Martha Mims, MD, PhD
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Detroit, Michigan 48201
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Detroit, MI
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New Orleans, Louisiana 70112
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New Orleans, LA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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