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International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Sponsor: Prostate Cancer Clinical Trials Consortium

NCT ID: NCT03151629

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Standard of Care (other)
How long the study runs
Study runs about 174 months (dates as stated)
About the drug or intervention
Standard of Care — other: Drugs routinely administered for metastatic prostate cancer per local standard.
Patient visit burden
Not specified by the sponsor

In plain English

IRONMAN is an international registry collecting information from men with advanced prostate cancer. A registry gathers health details over time to help researchers learn more about the condition. It is run by the Prostate Cancer Clinical Trials Consortium.

Who can take part

  • Men aged 21 or over.
  • Willing and able to give written permission (consent) and agree to share your personal health information.
  • Prostate cancer confirmed by tissue tests, or cancer that has spread in a pattern typical of prostate cancer (such as to bone or nearby lymph nodes) together with a high blood PSA (prostate-specific antigen) level above 20 ng/mL when first diagnosed.

Who may not be able to

  • Men who have been diagnosed with another cancer, other than prostate cancer, that needs further treatment. Exceptions are non-invasive bladder cancer and a common skin cancer called basal cell cancer.

What taking part involves

  • • Not stated — ask the trial team.

Time commitment: Not stated — ask the trial team about what taking part involves, how long it lasts, and how often you would be seen.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
21 Years and over
Who
Male
Number of participants
5,000
Started
2017-07-21
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Clinical study - 5,000 participants
  • • 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

Who can take part?

  • • Ages 21 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • Southampton - University Hospital Southampton NHS Foundation Trust
  • • Stevenage - Lister Hospital
  • • Northwood - Mount Vernon Cancer Centre
  • • Cardiff - Velindre Cancer Centre
  • • +9 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Prostate Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 21 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSA

Treatment history

Treatments you must have had:

  • ✓ additional systemic therapy except cancer in situ of bladder and basal cell cancer of skin

What the study is looking for

  • ✓Willing and able to provide written agreement to take part and privacy authorization for the release of personal health...
  • ✓NOTE: Privacy authorization may be either included in the agreement to take part or obtained separately.
  • ✓Males 21 years of age and above
  • ✓No previous diagnosis of a second, non-prostate cancer that requires additional treatment that goes through your whole body except cancer...
See the full 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

Where Is This Study? (13 UK sites)

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Recruiting
Site contact (verified)
Simon Crabb, MDPrincipal Investigator
Simon Crabb, MDsimon.crabb@uhs.nhs.uk

Lister Hospital

Stevenage SG1 4AB, United Kingdom

Recruiting
Site contact (verified)
Anand Sharma, MDPrincipal Investigator
Anand Sharma, MDanand.sharma3@nhs.net

Mount Vernon Cancer Centre

Northwood HA6 2RN, United Kingdom

Recruiting
Site contact (verified)
Anand Sharma, MDPrincipal Investigator
Anand Sharma, MDanand.sharma3@nhs.net

Velindre Cancer Centre

Cardiff, United Kingdom

Recruiting
Site contact (verified)
Jacob Tanguay, MDPrincipal Investigator

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, United Kingdom

Recruiting
Site contact (verified)
Alison Birtle, MDPrincipal Investigator
Alison Birtle, MDAlison.Birtle@mbht.nhs.uk

Guys St Thomas NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Deborah EntingPrincipal Investigator

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Vincent Khoo, MDPrincipal Investigator

The Christie NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Site contact (verified)

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Recruiting
Site contact (verified)
Isabel Syndikus, MDPrincipal Investigator
Isabel Syndikus, MDisabel.syndikus@nhs.net

Lancashire Teaching Hospitals NHS Foundation Trust

Preston PR2 9HT, United Kingdom

Recruiting
Site contact (verified)
Alison Birtle, MDPrincipal Investigator

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S10 2SB, United Kingdom

Recruiting
Site contact (verified)
Carmel Pezaro, MDPrincipal Investigator
Carmel Pezaro, MDcarmel.pezaro@nhs.net

South Tyneside District Hospital

South Shields NE34 0PL, United Kingdom

TERMINATED
Hospital R&D contact (matched)

Research and Development stsft.research@nhs.net

stsft.research@nhs.net0191 565 6256 ext 42143

Sunderland Royal Hospital

Sunderland SR4 7TP, United Kingdom

TERMINATED

How to Get in Touch

Jacob Vinson

Sponsor contact

CONTACT

646-888-0421 pcctcironmanregistry@mskcc.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-05