Comparing the side effects of Low Dose Rate Brachytherapy against Ultra-hypofractionated Radiotherapy using Spacer gel Treatment in men with low to intermediate risk prostate cancer
Key information
Principal Investigators:
Dr. William Hayhurst
Dr. Carla Perna
ClinicalTrials.gov ID: NCT07210502
email: william.hayhurst@nhs.net
LDR BURST Trial
The LDR BURST Trial aims to compare the toxicities of LDR Brachytherapy and Stereotactic Body Radiation therapy (SBRT) in men with low to intermediate risk prostate cancer with a rectal spacer gel (Cambridge Groups 1-3). This randomised control trial will measure urological and bowel toxicity, erectile dysfunction, and quality of life, in men receiving a rectal spacer in both arms of the study.
Within the UK, rectal spacer gels are not routinely available; however, where used, they have been shown to significantly reduce the radiation dose delivered to the rectum during radiotherapy.
The LDR BURST trial will assess if lowering the radiation dose to the rectum and surrounding tissue, reduces the radiation side effects following either LDR brachytherapy or SBRT. To our knowledge this is the first randomised control trial to compare these radiation treatments using a spacer gel.
Primary End Point
To determine whether there is improved toxicity and patient-reported quality of life following prostate stereotactic body radiation therapy (SBRT) compared with 4D Brachytherapy when using a spacer gel (4D Brachytherapy is a LDR Brachytherapy technique demonstrated to improve procedure time to 45 minutes). This will be assessed using EPIC 26 questionnaire
Secondary End Point
To determine the relative benefits of SBRT versus 4D Brachytherapy in terms of freedom from treatment failure (biochemical, clinical, local, or distant), survival (overall and disease-specific).
Secondary End Point cont.
Further patient and clinician toxicity assessments including an evaluation of patient experience during the screening, consenting and treatment pathway.
Spacer gel
Barrigel™ rectal spacer helps protect the rectum by reducing the amount of high-dose radiation that reaches it during treatment.
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Mariados NF, Orio PF III, King MT et al. Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. JAMA Oncol (2023). Study sponsored by Palette Life Sciences
The LDR BURST Trial team would like to thank the following organisations for their support.
