NCT07210502Not yet recruiting
Side Effects of Low Dose Rate Brachytherapy and Ultra-hypofractionated Radiotherapy in Low to Intermediate Risk Prostate Cancer
Comparing the Side Effects of Low Dose Rate Brachytherapy Against Ultra-Hypofractionated Radiotherapy Using Spacer Gel Treatment in Men With Cambridge Prognostic Groups (CPG) 1 to 3 (NCCN Low to Intermediate Risk) Prostate Cancer
Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 30 Jun 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Diseases
- Prostate cancer
- NCT number
- NCT07210502
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 1 Dec 2025 to the primary completion date, 1 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy.
- Prior treatment with ADT or current need for ADT based on risk features
- Prostate cancer in greater than 50% of template biopsy cores or a significant maximum core length containing prostate cancer for which the treating clinician deems the patient would benefit from ADT
- Any prior active treatment for prostate cancer (patients previously on active surveillance are eligible if they meet all other eligibility criteria)
- Contraindications for Barrigel insertion such as previous documented allergic reaction to gel, previous rectal surgery or known rectal fistula.
- Participation in another concurrent treatment protocol for prostate cancer.
Other illness
- 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.
- Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.
- Anticoagulation with warfarin/ bleeding tendency making fiducial placement, spacer gel insertion or brachytherapy unsafe in the opinion of the clinician
Age
- Life expectancy \< 10 years Men with a prostate gland larger than 60 cc, or those with a large median lobe• Hip prostheses or any other implants/hardware that introduce substantial CT artefacts making it challenging to delineate the target or organs at risk. This is to be assessed on a case-by-case basis with the available staging imaging.
Other
- Patients under investigation for synchronous primary at time of randomisation
- International Prostate Symptom Score (IPSS) \> 15 points
Who the study is looking for
- 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
- PSA ≤ 20 ng/ml (please note if the treating clinician determines androgen deprivation therapy (ADT) is required this is an exclusion criteria). A PSA must be available within 60 days of randomisation.
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Surrey NHS Foundation Trust Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.