ProSpare, a rectal obturator in post-prostatectomy radiotherapy v1.0
Research type
Research Study
Full title
POPS: A randomised phase II trial assessing Post-Operative use of ProSpare, a rectal obturator in prostate cancer radiotherapy
IRAS ID
180443
Contact name
Alison Tree
Contact email
Sponsor organisation
Institute of Cancer Research
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Surgery to remove the prostate gland is one of the ways of treating prostate cancer. Some patients receive radiotherapy after surgery to the area where the prostate was removed from, known as the prostate bed, if the cancer may not have been completely removed. Radiotherapy to the prostate bed can cause side effects, which can cause bowel and bladder symptoms as well as reducing sexual function.
To improve the accuracy in delivering the radiotherapy, a device called ProSpare, a single-use disposable device is inserted by the patient into the rectum daily at each radiotherapy treatment. The radiotherapy treatment takes around 15 minutes each day. This device has already been tested in patients having prostate radiotherapy and was well tolerated, with good treatment accuracy and a reduction in dose received by the rectum was calculated.
Other ways to identify the treatment area have been tested, including the insertion of markers into the prostate bed, however, this procedure does have associated risks. The device will help us to identify where the treatment area is at each radiotherapy session. ProSpare can be “seen” on the standard scans taken before a radiotherapy treatment and treatment position will be adjusted before each daily treatment using this information.
Patients will be randomly selected to either have standard treatment or use ProSpare daily with adjusted set-up margins, prior to this patients will complete a quality of life questionnaire. During and after treatment, patients will be asked questions and given questionnaires to complete, asking about bowel, urinary and sexual function. We will look at the results in each group and see if treatment with ProSpare has a benefit in improving the side effects from radiotherapy. If a benefit is seen, then our aim would be for ProSpare guided radiotherapy to become part of the standard treatment for prostate bed radiotherapy.REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1342
Date of REC Opinion
17 Sep 2015
REC opinion
Favourable Opinion