PRECISION

• Research type

  Research Study

• Full title

  A randomized control trial of magnetic resonance imaging-targeted biopsy compared to standard trans-rectal ultrasound guided biopsy for the diagnosis of prostate cancer in men without prior biopsy

• IRAS ID

  163605

• Contact name

  Susan Tebbs

• Contact email

  susan.tebbs@ucl.ac.uk

• Clinicaltrials.gov Identifier

  NCT02380027

• Clinicaltrials.gov Identifier

  CTU/2015/177, CCTU Reference Number

• Duration of Study in the UK

  2 years, 2 months, 1 days

• Research summary

  PRECISION: PRostate Evaluation for Clinically Important disease: Sampling using Image-guidance Or Not

  Background:
  Prostate cancer is the second most common cause of cancer death in European men, with 90,000 deaths per year in Europe.

  National Institute of Clinical Excellence standard of care for the diagnosis of prostate cancer in men without prior biopsy is trans-rectal ultrasound guided (TRUS) prostate biopsy. This test can be offered by most Urology centres and is a quick outpatient procedure under local anaesthetic. Biopsies are directed to areas where most cancer is thought to be present. However no test is perfect and some cancer may be missed.

  An alternative diagnostic pathway is one influenced by MRI. Men with a suspicious MRI can undergo prostate biopsy where biopsies are taken from where the suspicious areas are indicated on MRI (MRI-targeted biopsy). This may lead to more accurate diagnosis with fewer biopsies. Men with a non-suspicious MRI can avoid a biopsy and undergo surveillance thus avoiding the pain and complications associated with a biopsy.

  Evidence from well designed randomised controlled trials is required to compare detection rates of cancer of each technique for clinical practice to be changed.

  Research question:
  What is the detection rate of clinically significant and clinically insignificant cancer by TRUS biopsy and MRI-targeted biopsy?

  Who is eligible:
  Men with clinical suspicion of prostate cancer

  Design:
  PRECISION is an international multi-centre randomised controlled trial in which 470 men will be recruited at their local hospital where they were referred. 235 men will be randomly allocated to TRUS biopsy and 235 to MRI. Men with a suspicious MRI undergo MRI-targeted biopsy. MRI-targeted biopsy can be carried out with the assistance of computer software. After a biopsy men complete the study after 30 days. Men with a non-suspicious MRI do not undergo biopsy. Men complete complication and quality of life questionnaires.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  15/EM/0188

• Date of REC Opinion

  7 May 2015

• REC opinion

  Favourable Opinion