SMART TARGET (Therapy Study)

• Research type

  Research Study

• Full title

  SmartTarget - A phase 2a Study of non-rigid MRI to Ultrasound Image Fusion System for Targeted Prostate Interventions (Therapy)

• IRAS ID

  146836

• Contact name

  Mark Emberton

• Contact email

  m.emberton@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2014/02/04, Data Protection Number

• Research summary

  This study is designed to find out how accurately High Intensity Focussed Ultrasound (HIFU) therapy can be delivered to treat prostate cancer with the aid of new computer software. The software enables the operating surgeon to create a surgical plan that focuses on treating the tumour and minimises damage to healthy tissue.
  Traditionally, treatment of prostate cancer is directed to the whole of the prostate. That is, if a patient has prostate cancer that needs to be treated, either the whole prostate is removed, or radiation is directed to the whole gland. This is associated with side effects such as impotence (1 in 2 risk), incontinence of urine (1 in 5 risk) and rectal symptoms (1-2 in 5 risk).

  An alternative to whole gland treatment is to target just the cancer within the prostate and leave normal, healthy prostate behind – this is called focal therapy.
  The problems with targeting less than the whole prostate could be, treating more normal prostate tissue than required and the risk under-treatment because the margin of tissue is not adequate. Both of these problems arise because we cannot match the pre-treatment MRI to the ultrasound at the time of operation.

  SmartTarget is an MRI to ultrasound fusion software that matches the MRI information to ultrasound image, guiding the surgeon to where the HIFU needs to be delivered to treat the cancer. By using this software we may be able to treat more accurately the areas that we want to and reduce the amount of normal tissue that is treated. This might further reduce side effects, whilst keeping or possibly improving cancer control.

  In this study we will compare pre-treatment MR-images to post-treatment MR-images and compare how accurately the treatment was delivered, as well as assessing early side-effect outcomes.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  14/LO/1375

• Date of REC Opinion

  27 Oct 2014

• REC opinion

  Further Information Favourable Opinion