IRONMAN: International Registry for Men with Advanced Prostate Cancer

Study ID: 39336
Short Title: IRONMAN Registry
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Urology
Phase: N/A
Expected End Date: 22/12/2027
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

To be included in the IRONMAN Registry, subjects should meet the following criteria at the time of registration: 1. Willing and able to provide written informed consent and privacy authorisation for the release of personal health information 2. Males 21 years of age and above 3. Histological or cytological confirmed prostate cancer from prostate biopsy, radical prostatectomy or Transurethral Resection of the Prostate (TURP) Or Documented histopathology or cytopathology of prostate cancer from a biopsy of a metastatic site Or Metastatic disease typical of prostate cancer (i.e. involving bone or pelvic/extra pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA > 20ng/mL 4. Metastatic hormone sensitive prostate cancer (mHSPC): a) No more than 1 year of continuous androgen deprivation therapy (ADT) exposure prior to consent, with documented recovery of testosterone as determined by investigator. b) No more than 90 days of active systemic therapy at the time of consent c) Metastatic disease M1a, b, or c stage as defined by the American Joint Committee on Cancer Or Castration resistant prostate cancer (CRPC) a) A rising PSA indicating progressing disease or new metastatic disease as determined by the investigator I. While on ADT (or orchidectomy) or II. With castrate level of testosterone as determined by investigator b) No more than 6 weeks of continuous systemic therapy for CRPC at the time of consent I. NOTE: Prior systemic therapy for any length of time for mHSPC is allowed for patients currently with CRPC 5. No active systemic treatment for a diagnosis of a second, non-prostate malignancy 6. For both mHSPC and CRPC, prior treatment with bisphosphonate or denosumab will be permitted.

1. Previous diagnosis of a second, non-prostate malignancy that requires additional systemic therapy. 2. Men with mHSPC who have received active systemic therapy for longer than 90 days prior to consent. 3. Men with CRPC who have received continuous systemic therapy for CRPC for longer than 6 weeks prior to consent.

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.

Study MapList of studies

Accessibility tools

Return to header