International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Overview

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.

Interventions

• Other Standard of Care
  Drugs routinely administered for metastatic prostate cancer per local standard.

Primary outcome measures

• Practice Patterns [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 48 centers

• University of Alabama-Birmingham — Birmingham
• University of Alabama- Tuscaloosa — Tuscaloosa
• University of California - Los Angeles — Los Angeles
• University of California San Diego — San Diego
• Yale University — New Haven
• University of Florida — Gainesville
• Mayo Clinic Jacksonville — Jacksonville
• Moffitt Cancer Center — Tampa
• … and 40 more centers

United Kingdom · 13 centers

Center list to be confirmed — check the primary protocol.

Spain · 12 centers

Center list to be confirmed — check the primary protocol.

Australia · 11 centers

• Royal Brisbane & Women's Hospital — Herston
• St. Vincent's Hospital Sydney — Darlinghurst
• Macquarie University — Sydney
• Westmead Hospital — Sydney
• Redland Hospital — Cleveland
• Princess Alexandra Hospital — Woolloongabba
• Eastern Health (Box Hill Hospital) — Box Hill
• Peter MacCallum Cancer Centre — Melbourne
• … and 3 more centers

Canada · 7 centers

• Cross Cancer Institute (Alberta Health Services) — Edmonton
• BC Cancer Agency — Vancouver
• Juravinski Cancer Centre — Hamilton
• Ottawa Hospital Cancer Centre — Ottawa
• Princess Margaret Cancer Centre — Toronto
• Centre hospitalier de l'Université de Montréal (CHUM) — Montreal
• CHU de Québec-Université Laval — Québec

Brazil · 6 centers

• Tacchini Hospital — Bento Gonçalves
• Hospital Beneficência Portuguesa — Bela Vista
• Instituto do Câncer e Transplante — Curitiba
• Centro de Pesquisa em Oncologia — Porto Alegre
• Centro Paulista de Oncologia — São Paulo
• Instituto Câncer do Estado de São Paulo — São Paulo

Switzerland · 6 centers

Center list to be confirmed — check the primary protocol.

Ireland · 4 centers

• Beacon Hospital — Dublin
• Tallaght University Hospital — Dublin
• St. Vincent's University Hospital — Dublin
• Sligo University Hospital — Sligo

Nigeria · 4 centers

• Federal Medical Centre Abeokuta — Abeokuta
• … and 3 more centers

South Africa · 3 centers

Center list to be confirmed — check the primary protocol.

Sweden · 3 centers

Center list to be confirmed — check the primary protocol.

Barbados · 1 center

• The University of the West Indies - Cave Hill Campus — Bridgetown

Jamaica · 1 center

• The University of the West Indies - Mona Campus — Kingston

Kenya · 1 center

• University of Nairobi — Nairobi

Norway · 1 center

Center list to be confirmed — check the primary protocol.

Publications

• Rencsok EM, Slopen N, McManus HD, Autio KA, Morgans AK, McSwain L, Barata P, Cheng HH, Dreicer R, Gerke T, Green R, Heath EI, Howard LE, McKay RR, Nowak J, Pileggi S, Pomerantz MM, Rathkopf DE, Tagawa ST, Whang YE, Ragin C, Odedina FT, Kantoff PW, Vinson J, Villanti P, Haneuse S, Mucci LA, George DJ; IRONMAN Registry. Pain and Its Association with Survival for Black and White Individuals with Adva PMID 38108490
• Rencsok EM, Stopsack KH, Slopen N, Odedina FT, Ragin C, Nowak J, McSwain L, Manarite J, Heath E, George DJ, Kantoff PW, Vinson J, Villanti P, Haneuse S, Mucci LA; IRONMAN Registry. Experience with the US health care system for Black and White patients with advanced prostate cancer. Cancer. 2023 Aug 15;129(16):2532-2541. doi: 10.1002/cncr.34885. Epub 2023 May 28. PMID 37246339
• 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: PMID 33835826

Identifiers

NCT: NCT03151629 · c16-170

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗