The LDR BURST trial will compare the side effects of two radiotherapy treatments for men with localised prostate cancer. The first treatment is 4D low dose rate brachytherapy where small radioactive seeds are inserted into the prostate gland under ultrasound guidance. A computerised tomography scan is subsequently performed to check seed positioning. Patients usually return home the same day. The seeds emit their radiation over several months before losing their activity.
Stereotactic radiotherapy, an alternative treatment, is a form of external radiation using precise high energy x-rays to target the prostate gland. It is delivered in 5 treatment sessions on alternate days; the full treatment course is completed within 2 weeks.
Stereotactic radiotherapy has recently been approved by the National Health Service following successful results in international trials demonstrating it is safe and effective to give external radiotherapy in five treatment sessions. Delivering a higher dose in each treatment fraction is known as 'ultra-hypofractionation'. Before the treatment, men will undergo a minor procedure, typically under local anaesthetic, to have metallic markers inserted into the prostate to improve visibility of the prostate gland when planning and delivering the treatment.
The side effects of both the radiation treatments are similar. Common side effects include bladder issues, such as needing to urinate more often and having a slower urine flow. Patients might also experience more frequent and looser bowel movements, occasionally with a little blood. Symptoms usually improve over time. Additionally, some men might have trouble achieving or maintaining an erection after radiation treatment, this can often be managed with medications.
Both of the treatments use ionising radiation to destroy the prostate cancer cells which may cause cancer many years or decades after exposure. The chances of this happening are the same whether taking part in this trial or not.
A protective gel, called Barrigel, will be inserted into the space between the prostate gland and the rectum increasing the distance between them. This significantly reduces the dose of radiation to the rectum. The gel can be inserted at the same time as the brachytherapy seed or fiducial marker insertion. The gel is slowly reabsorbed following treatment over the next 3 to 6 months.
The trial will randomly assign 110 men to each radiation treatment to compare their side effects. There is a 50% chance the patient will be assigned to brachytherapy and 50% chance of stereotactic radiotherapy. Patients will be asked to complete four questionnaires prior to starting treatment and at regular time points following treatment. They will be telephoned every 4 weeks for the first 2 months to check on side effects, followed by a face-to-face appointment at 3 months, and a PSA blood test, and then followed up at regular intervals for 5 years.
Men aged ≥18 years at randomisation
The research subject must have capacity to sign a written informed consent document for the trial
WHO performance status 0 - 2
Gleason score 3+3 or 3+4
Clinical and/or MRI stage T1c -T2c, N0-X, M0-X
Histological confirmation of prostate adenocarcinoma within the last 18 months (unless on active surveillance). Patients who were on active surveillance should have an up-to-date MRI within 8 weeks of the decision to treat to confirm organ confined disease.
Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 10-year survival.
Patients under investigation for synchronous primary at time of randomisation
Parallel
4D Low Dose Rate Prostate Brachytherapy
RadiationPermanent implantation of radioactive seeds in the prostate gland which slowly deposit half their dose approximately every 60 days. Prescription dose 145 Gy.
Ultra-hypofractionated Radiotherapy
RadiationThe prescription dose is 36.25 Gy given in 5 fractions over 1-2 weeks (i.e. daily or alternate daily at department discretion) delivered on linear accelerator
EPIC-26 score minimally important difference
The EPIC-26 questionnaire is a preeminent tool extensively characterised to measure health-related quality of life in men with localised prostate cancer. Our study is powered to detect the minimally important differences in urinary, sexual, and bowel function domains relative to the pre-treatment values.
International Prostate Symptom Score (IPSS)
IPSS assesses urinary voiding symptoms and bother. For voiding symptoms, a score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms, and the urinary bother scale ranges from 0 (Delighted) to 6 (Terrible).
International Index of Erectile Function (IIEF-5)
The IIEF-5, also known as the Sexual Health Inventory for Men (SHIM) score , characterises the severity of erectile dysfunction (ED) with lower scores indicating greater dysfunction (5-7 severe, 8-11 moderate, 12-16 mild-to-moderate, 17-21 mild, 22-25 no ED).
Vaizey faecal inconticence score
The Vaizey Incontinence Score is a general-purpose scale for faecal incontinence that ranges from 0 to 24 with higher scores representing worst incontinence.
Prostate-Specific Antigen (PSA)
PSA - 3 consecutive PSA rises within the first 2 years post treatment or a PSA rise of 2 ng/mL or more from the patient's nadir result after the 4 year time point will be deemed as biochemical failure and warrants further re-staging investigations. Patients will be kept on follow up for the 5 year follow up period, if appropriate, despite biochemical failure, to account for late PSA bounces .
Survival
Survival outcomes are time-to-event variables i.e. relapse-free survival, cancer-specific survival, and overall survival.
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