None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the safety, clinical outcomes, patient preferences and economic benefits of reduced margins for radiation therapy for prostate cancer, with the use of the Clarity Autoscan ultrasound system. Who is it for? You may be eligible to participate in this trial if you are aged 50 or over and have been diagnosed with prostate cancer, for which you are scheduled to commence radiation therapy treatment. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either a reduced margin around the prostate during radiation therapy of 3-5mm, or to receive the standard margin of 7-10mm. All patients, regardless of allocation will have fiducial markers inserted prior to commencement of treatment, and will have the Clarity Autoscan ultrasound monitoring prostate motion throughout treatment, increasing the accuracy of treatment. The allocated treatment protocol will continue for all radiation therapy treatment sessions (up to 39). Researchers will ask participants for their preference regarding monitoring during radiotherapy, and the acceptability of the Clarity Autoscan system. Participants will also be followed up for up to five years post treatment to assess side effects and for one year to evaluate the cost-effectiveness of the motion monitoring. It is hoped that the findings from this trial can be used to inform a health technology assessment reviewing the safety, efficacy and cost-efficacy of reduced margins during radiotherapy for prostate cancer using the Clarity Autoscan system.
Interventions
The Clarity Autoscan ultrasound system allows radiation therapists to track the position of the prostate in real time by the application of an ultrasound probe against the perineum during treatment delivery daily. An alert is generated if the prostate moves beyond a pre-specified parameter, allowing the radiation therapist to suspend treatment and take
corrective action to ensure accuracy is maintained. The Clarity Autoscan system is non-invasive and does not utilise any additional radiation. In
The Clarity Autoscan ultrasound system allows radiation therapists to track the position of the prostate in real time by the application of an ultrasound probe against the perineum during treatment delivery daily. An alert is generated if the prostate moves beyond a pre-specified parameter, allowing the radiation therapist to suspend treatment and take corrective action to ensure accuracy is maintained. The Clarity Autoscan system is non-invasive and does not utilise any additional radiation. In this study, all patients (both control and intervention groups) will have fiducial markers inserted as per standard practice, in addition to the Clarity Autoscan monitoring. In the radiation therapy treatment of the prostate with Clarity Autoscan, the margin around the prostate for treatment delivery will be reduced to 5mm (with 3mm in the posterior). The prostate shall be monitored for any motion using ultrasound by qualified radiation therapists during treatment delivery, and if it moves greater than the defined margin (i.e. 5mm, with 3mm in the posterior), the treatment will be paused and the patient position corrected for. This will occur for all daily treatments (up to 39).
Sponsors
The Townsville Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histological confirmed malignant neoplasm of the prostate 2. Presenting to Townsville Cancer Centre for radiation therapy treatment from March 2017 3. Suitable for fiducial marker implantation and Clarity tracking capabilities 4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less 5. Has provided written Informed Consent for participation in this study
Exclusion criteria
1. Evidence of distant metastases 2. Major concurrent physical or psychiatric illness which would prevent completion of treatment or adequate follow-up either through disablement or limitation of life expectancy to less than 1 year. 3. Cognition, language or literacy difficulties which would prevent the completion of QOL and other questionnaires.
Outcome results
None listed