PRINToUT
Research type
Research Study
Full title
Using breath analysis via Gas Chromatography Ion Mobility Spectrometry (GC-IMS) to predict normal tissue and tumour response during prostate cancer stereotactic body radiotherapy (SBRT) with RayPilot® motion management.
IRAS ID
240335
Contact name
Duncan B McLaren
Contact email
Sponsor organisation
NHS Lothian Research and Development
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Radiotherapy can cure prostate cancer; however, all patients are exposed to potential treatment related toxicity that can affect ongoing quality of life. The side effects that occur during the radiotherapy are termed 'acute' while those that appear more than 6 months after completion of radiotherapy and are called 'late'. For those patients who experience significant acute toxicity, such as significant bowel or bladder disturbance, there is an increased risk of subsequent late effects. As yet it is not possible to identify these patients at risk and to alter their radiotherapy dose or treatment schedule to reduce this risk. It is accepted that for any given radiotherapy dose, up to 10% patients may experience significant toxicity. It has been a long-term aim of radiation oncology to identify those men at risk of increased normal tissue toxicity. We believe that measuring the release of volatile organic compounds from the tissues of prostate cancer patients exposed to high dose stereotactic body radiotherapy (SBRT) within the breath may provide a fast, accurate and sensitive assay of excessive normal tissue damage. We will also look at the release of circulating tumour and normal tissue DNA in the blood and urine with each fraction of radiotherapy treatment and compare this to the breath analysis. In addition we will look at the radiotherapy gene signatures of each patient treated to look at specific gene mutations that may predict for toxicity and correlate with the breath analysis. These mutations will be compared to the patients germline DNA collected via a saliva sample. Patient treatment related toxicity will be assessed by standard RTOG & CTCAE toxicity grading and patient reported outcome measures (PROMS) using EPIC-CP.
REC name
South East Scotland REC 02
REC reference
18/SS/0083
Date of REC Opinion
6 Jul 2018
REC opinion
Further Information Favourable Opinion