A study to assess the immune status in prostate cancer

• Research type

  Research Study

• Full title

  A study to assess the immune status and biomarker discovery in patients with prostate cancer.

• IRAS ID

  139068

• Contact name

  Masood A Khan

• Contact email

  masood.khan@uhl-tr.nhs.uk

• Sponsor organisation

  University Hospitals Leicester

• Research summary

  Prostate cancer is the most common cancer among men in the UK and the second most common malignant disease in the UK, and there is at present no curative treatment for metastatic prostate cancer. Prostate cancer is currently categorised into low, intermediate and high-risk prognostic groups on the basis of Prostate Specific Antigen (PSA) level, Gleason score and digital rectal examination (DRE). Patients diagnosed with low risk cancer are considered for “active surveillance”, and treatment is only considered for these patients should there be evidence of disease progression in order to avoid unnecessary treatment and risk-related side-effects. Patients on active surveillance undergo six-monthly PSA tests, DRE and yearly trans-rectal ultrasound (TRUS) guided prostate biopsies in order to exclude disease progression and active therapy. However, PSA can be an inaccurate predictor of disease progression and TRUS guided prostate biopsies are associated with urosepsis in 5% of patients.
  The immune system is important for protecting against infectious disease and cancer, and although a substantial body of evidence indicates that the immune system is altered due to the presence of tumours and factors that are derived therefrom, it is not known which aspects of the immune system will be able to anticipate disease progression in patients with prostate cancer whose disease has been categorised as being “intermediate”. We hypothesise that the immune status of patients with prostate cancer and patients with high risk of progressing will be different from that of patients with benign tumours, tumour-free patients and patients that are at a low risk of progressing and that significant phenotypic changes will be observed using the latest multi-colour flow cytometry analysis.
  The urine will be analysed for both novel and known biomarkers which associate with disease status using the state-of-the-art proteomics technology

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  14/ES/1014

• Date of REC Opinion

  18 Jun 2014

• REC opinion

  Further Information Favourable Opinion