The Clarity-Pro Study

• Research type

  Research Study

• Full title

  Evaluation of Clarity ultrasound guidance for Prostate radiotherapy

• IRAS ID

  166454

• Contact name

  Emma J Harris

• Contact email

  emma.harris@icr.ac.uk

• Duration of Study in the UK

  1 years, 2 months, 30 days

• Research summary

  Radiotherapy (RT) is an important treatment for prostate cancer with over 10,000 men receiving RT per year in the UK. Prostate RT aims to deliver radiation dose to the prostate to kill cancer cells whilst minimising the dose given to surrounding normal tissues, such as the bladder or the rectum. Radiation is delivered in a number of daily treatments which are called ‘fractions’. The position of the prostate varies each day and during the radiation delivery. To accurately aim the radiation we need to locate the prostate before daily treatment. Techniques to do this include implanting gold or electromagnetic markers into the prostate and using imaging or sensing techniques to pinpoint their location.
  Although these markers allow accurate treatment, they are invasive, requiring implantation of markers in a procedure similar to a prostate biopsy. This is uncomfortable for patients and has a small risk of serious infection afterwards.
  Clarity is an ultrasound image guidance system that locates the prostate and monitors its position during treatment. Ultrasound does not give a radiation dose, is non-invasive, provides fast imaging and can easily visualise soft tissues. Before Clarity is implemented we wish to ensure that it can accurately locate and monitor the prostate. We will do this by comparing Clarity with marker-based techniques in 24 trial patients who will be receiving or have received markers as part of their treatment. Clarity will be considered a safe and effective imaging system if the mean and standard deviation of the differences between Clarity measurements and marker measurements, of prostate position, are less than 1mm. It is possible that markers will influence the Clarity measurements. To find out if this happens, we will compare the mean and standard deviation of Clarity measurements in a group of 24 patients without markers to the group with markers.

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  15/LO/0610

• Date of REC Opinion

  30 Apr 2015

• REC opinion

  Further Information Favourable Opinion