Clinical trial NCT03151629: International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Official title: International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Prostate Cancer Clinical Trials Consortium
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 5000
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic hormone sensitive prostate cancer (mHSPC): Prostate cancer patients diagnosed with histologically confirmed cancer with radiological evidence of metastatic disease and on ADT for no more than 90 days.

Castration resistant prostate cancer (CRPC): Prostate cancer patients (with or without radiological evidence of metastatic disease) with a confirmed rising PSA (at least two measures) while on ADT or orchiectomy or castrate level of testosterone as determined by investigator.

Prostate cancer patients with mixed histological types may participate in this Registry.

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.


Eligibility 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

Primary outcomes:
measure: Practice Patterns
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Tuscaloosa
country: United States
facility: University of Alabama- Tuscaloosa
state: Alabama
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: DeKalb
country: United States
facility: Kishwaukee Cancer Center
state: Illinois
city: Geneva
country: United States
facility: Delnor Cancer Center
state: Illinois
city: Warrenville
country: United States
facility: Warrenville Cancer Center
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Buffalo
country: United States
facility: VA Western New York Healthcare System
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Network
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University Hospital
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Temple Health
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Health System
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Columbia
country: United States
facility: William Jennings Bryan Dorn VAMC
state: South Carolina
city: Memphis
country: United States
facility: Memphis VA Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Brisbane
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Cleveland
country: Australia
facility: Redland Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health (Box Hill Hospital)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Mount Waverley
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Melbourne N.
country: Australia
facility: Australian Prostate Centre
city: Melbourne
country: Australia
facility: Australian Urology Associates
city: Bridgetown
country: Barbados
facility: The University of the West Indies - Cave Hill Campus
city: Bento Gonçalves
country: Brazil
facility: Tacchini Hospital
state: Rio Grande Do Sul
city: Bela Vista
country: Brazil
facility: Hospital Beneficência Portuguesa
state: São Paulo
city: Curitiba
country: Brazil
facility: Instituto do Câncer e Transplante
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisa em Oncologia
city: São Paulo
country: Brazil
facility: Centro Paulista de Oncologia
city: São Paulo
country: Brazil
facility: Instituto Câncer do Estado de São Paulo
city: Edmonton
country: Canada
facility: Cross Cancer Institute (Alberta Health Services)
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec-Université Laval
state: Quebec
city: Dublin
country: Ireland
facility: Beacon Hospital
state: Leinster
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Sligo
country: Ireland
facility: Sligo University Hospital
city: Kingston
country: Jamaica
facility: The University of the West Indies - Mona Campus
city: Nairobi
country: Kenya
facility: University of Nairobi
city: Abeokuta
country: Nigeria
facility: Federal Medical Centre Abeokuta
city: Ilorin
country: Nigeria
facility: University of Ilorin Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos State University Teaching Hospital
city: Maiduguri
country: Nigeria
facility: University of Maiduguri Teaching Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital
state: Gauteng
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology
state: Catalunya
city: Badalona
country: Spain
facility: Institut Catalá d'Oncologia Badalona
city: Barcelona
country: Spain
facility: Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar).
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Castellón De La Plana
country: Spain
facility: Hospital Provincial de Castellón
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet (Zaragoza)
city: Malmö
country: Sweden
facility: Skane University Hospital
state: Skane
city: Umeå
country: Sweden
facility: Umea University Hospital
city: Örebro
country: Sweden
facility: Orebro University Hospital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliero Cantonale
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Onkozentrum Zürich
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: Hertfordshire
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Lancaster
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
city: London
country: United Kingdom
facility: Guys St Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: South Shields
country: United Kingdom
facility: South Tyneside District Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre
Study officials:
affiliation: Duke Cancer Institute
name: Daniel George, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Lorelei Mucci, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Phillip Kantoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.