TRICREST

• Research type

  Research Study

• Full title

  A PHASE II SINGLE ARM, MULTI-CENTRE TRIAL OF TRIAMCINOLONE WITH A GNRH ANALOG FOR CASTRATION RESISTANT PROSTATE CANCER

• IRAS ID

  61869

• Sponsor organisation

  Barts Health NHS Trust

• Eudract number

  2010 022010 32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Prostate cancer is initially responsive to hormone therapy (HT), however for the majority of patients, the disease eventually becomes resistant to this treatment and develops into castration resistant prostate cancer (CRPC). At this point, expected survival time decreases to between 18 and 24 months with available treatment options offering a limited response time. The study provides a new option for CRPC. Corticosteroids are used at this point in the disease. There is increasing evidence that the ability of a steroid to control prostate cancer is independent of its function as a glucocorticoid. Dexamethasone is frequently chosen ?? it is oral, convenient and provides disease control for a median 4-6 months. The steroid triamcinolone suppresses endogenous adrenal androgen production in a similar way to dexamethasone but unlike dexamethasone has no ability to stimulate the androgen receptor and thus prostate cancer growth, - it therefore should produce longer lasting remissions. This expectation is based on results from a previous trial, which resulted in a moderate response, and response in this trial may have been limited because the dosage of triamcinolone given was low. Triamcinolone has been used extensively to treat arthritis and asthma. The data from these trials guides dosage in this trial.To understand the action of the drug, urine and blood samples collected during the treatment period and they will be analysed to check if triamcinolone has reduced or stopped the production of androgens. Additionally, an optional part of the trial will be to take a small blood sample before beginning treatment which will be used in further research, including analysis for previously identified mutations which may contribute towards the development of CRPC.This will help build a clearer picture of how the CRPC responds to this treatment, and improve the available information for the use of triamcinolone in this setting.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/LO/0328

• Date of REC Opinion

  15 Aug 2011

• REC opinion

  Further Information Favourable Opinion