IRONMAN
Research type
Research Study
Full title
IRONMAN: International Registry for Men with Advanced Prostate Cancer
IRAS ID
225518
Contact name
Deborah Enting
Contact email
Sponsor organisation
Guy's & St Thomas' Foundation NHS Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT03151629, ClinicalTrial.gov Identifier
Duration of Study in the UK
5 years, 5 months, 24 days
Research summary
IRONMAN is an international registry study of men with advanced prostate cancer.
The treatment of advanced prostate cancer has changed significantly over the past 10 years. There are now multiple drug treatments available for men with advanced prostate cancer. The use of these drugs has resulted in improved survival and quality of life for many patients. However a number of questions still remain including the observation that some patients have an excellent and long response to treatment, whilst others do not. We also do not have any biomarkers helping chose the best treatment for an individual patient.
The aim of this research study is to learn more about prostate cancer and to describe the use of different therapies for advanced prostate cancer internationally. The study also aims to identify associations between treatment sequences and outcome and investigate biomarkers which could be helpful with deciding which treatment is best for which patient. Finally this study will also investigate the patient experience of men with advanced prostate cancer and identify any unmet needs in their treatment.
World wide 5,000 patients will be recruited to IRONMAN, including the UK, US, Canada, Brazil, Australia, and Europe. Patients will be recruited from hospitals treating patients with advanced prostate cancer.
This registry study does not involve a new drug or treatment but will focus on collecting real-life information on a patient’s cancer, treatment, symptoms, and quality of life. Hospital visits will be every 3 months and these will coincide with routine visits. Blood samples will be taken for biomarker research and this will take place at study entry, after 1 year and at each point a patient changes prostate cancer treatment. Patients will be followed up for at least 3 years.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0464
Date of REC Opinion
10 Sep 2018
REC opinion
Further Information Favourable Opinion