Personal health status of men during localised prostate radiotherapy
Research type
Research Study
Full title
A pilot study of Patient Reported Outcomes evaluating treatment related symptoms and quality of life for Men receiving high dose rate brAchytherapy combined with hypo-fractionated radiotherapy or hypo-fractioNated radiotherapy alone for the treatment of localised prostate cancer
IRAS ID
222800
Contact name
Karen Crowther
Contact email
Sponsor organisation
Ulster University
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
The study population are men diagnosed with a localised prostate cancer who will be receiving radiotherapy treatment.\nProstate cancer is one of the most common malignancies worldwide and in the United Kingdom it accounts for a quarter of all diagnosed cancers in men. \nDefinitive treatment options for early-stage disease (which is localised to the prostate) include surgery and radiotherapy, both of which have high success rates for biochemical control. \nThe objective of this pilot study is to demonstrate the feasibility of a larger study, which is sufficiently powered to detect changes in Quality of Life (QoL) and treatment related symptoms between High-Dose Rate Brachytherapy (HDR-BT) combined with Hypofractionated Radiotherapy (HFRT) or HFRT alone. Both treatment regimes are included within the Radiotherapy Department’s Prostate Clinical protocol. \nThis study will use validated questionnaires completed by the study participants as the outcome measures.\nThere is currently limited published literature evaluating treatment related symptoms and QoL during HDR-BT combined with HFRT or HFRT treatment regime. This patient group are currently being managed during and post treatment using the review protocol as the established HFRT regime. The findings from this study will provide valuable evidence to inform future practice in the management of patients receiving HDR-BT combined with HFRT. The information gained will benefit both healthcare professionals and future patients. It will also provide the information required to design a powered study.\nThe patients will be considered a participant of the study from consent until 8 weeks after completion of treatment. All patients will be attending the Cancer Centre, Belfast City Hospital for treatment and follow-up reviews.\n
REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0050
Date of REC Opinion
16 May 2017
REC opinion
Favourable Opinion