Role of ConfirmMDx for Prostate Cancer™ in prostate cancer detection

• Research type

  Research Study

• Full title

  Performance of ConfirmMDx for Prostate Cancer™ in Negative TRUS-guided biopsy Tissue Cores where Cancer was Later Detected in a Transperineal Template Prostate Biopsy

• IRAS ID

  162328

• Contact name

  Masood/MA Khan

• Contact email

  masood.khan@uhl-tr.nhs.uk

• Sponsor organisation

  University Hospitals of Leicester NHS Trust

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  The objective of this retrospective study is to test cancer-negative prostate biopsy tissue cores from men who were later diagnosed with prostate cancer using an expanded biopsy technique, namely, transperineal template prostate biopsies (TPTPB). The results of this pilot study will give a preliminary evidence of the ConfirmMDx for Prostate Cancer assay to help identify men who could potentially be ideal candidates for template biopsies. All testing will be done blindly without knowledge by laboratory personnel of subjects’ ultimate cancer detection status in the TTPB.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  15/SC/0343

• Date of REC Opinion

  28 May 2015

• REC opinion

  Favourable Opinion