IRONMAN Registry Study

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. 

Research Nurse: Andrew Shah: andrew.shah@mbht.nhs.uk

Administrators: research.randr@mbht.nhs.uk