ICEman
Research type
Research Study
Full title
Investigation of SpaCEOAR for Men with High Risk Prostate CAncer treated with HDR Brachytherapy Boost and ExterNal Beam Radiotherapy
IRAS ID
200797
Contact name
Heather Payne
Contact email
Sponsor organisation
University College London (UCL)
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
There is a major unmet need to improve outcomes for men diagnosed with aggressive (high risk) or locally advanced prostate cancer who are known to have the biggest benefit from higher doses of radiotherapy. Our aim is to investigate the use of SpaceOAR in this group of men who will be treated with HDRb boost and pelvic intensity modulated radiotherapy (IMRT). We will be the first centre in England to use SpaceOAR in men undergoing these high dose radiotherapy treatments.\n\nThe main objectives of this study are to determine the feasibility and tolerability of insertion of a pre-rectal spacer (SpaceOAR) prior to HDRb to the prostate followed by external beam radiotherapy and to determine patient reported outcomes of bowel side effects in men undergoing this treatment. \n\nOther objectives of the study are as follows:\n\nTo determine early and late bowel side effects in men undergoing this treatment\nTo determine early and late urinary side effects in men undergoing treatment\nTo determine changes in quality of life reported by patients \nTo determine distance between the prostate and rectum following insertion of SpaceOAR\nTo determine the time taken for SpaceOAR to be reabsorbed \nTo determine the radiotherapy dose delivered to the rectum volume both with and without SpaceOAR in situ using virtual theoretical radiotherapy plans\nTo evaluate the maximum dose the prostate can safely be escalated to using EBRT alone or EBRT with HDRb boost when a pre-rectal spacer is in situ\n\n\nUltimately we aim want to be able to increase the number of men being cured and give survivors the least possible side effects from their cancer treatments.\n
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0977
Date of REC Opinion
20 Jun 2017
REC opinion
Favourable Opinion