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

LDR BURST Trial

We are committed to advancing prostate cancer research through transparency and collaboration. Our aim is to provide vital information about the key outcomes from this randomised trial.

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Key information

Principle Investigators:

Dr. William Hayhurst

Dr. Carla Perna

ClinicalTrials.gov ID: NCT07210502

email: william.hayhurst@nhs.net

Status: Recruiting

LDR BURST Trial

The LDR BURST Trial aims to compare toxicities of LDR Brachytherapy and Stereotactic Body Radiotherapy (SBRT) treatment in men with low to intermediate risk prostate cancer. The randomised control trial will measure urological and bowel toxicity, erectile dysfunction, and quality of life, with men receiving a rectal spacer in both arms of the study. There are currently no published randomised control trial that is similar, but recruitment to compare LDR brachytherapy and SBRT at 5 fractions, without rectal spacers, have started internationally to determine similar outcomes.

Both forms of treatment involve irradiating energies at the cancer, however dose delivery and energy to the prostate differ, with strong evidence showing patient survival in each case but comparable toxicity outcomes. Spacer gels are not widely available but have demonstrated to reduce rectal toxicities and will be measured as part of the trial to determine any difference between each treatment method. Comparing both treatments may yield expected results, however, comparing the two under a new 5 fraction SBRT regime with a rectal spacer in a randomise control study will further assist in patient treatment pathway options. The trial will aim to compliment existing research and establish the following:

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). The questionnaire will mirror PACE B Trial.

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), toxicity and quality of life in generic and organ specific domains.

Secondary End Point cont.

Evaluation of patient experience during the screening, consenting and treatment pathway.