Not yet recruitingNAINTERVENTIONAL

Side Effects of Low Dose Rate Brachytherapy and Ultra-hypofractionated Radiotherapy in Low to Intermediate Risk Prostate Cancer

The LDR BURST trial is investigating two common radiation treatments for men with early-stage prostate cancer. One is called 4D low dose rate brachytherapy, where small radioactive seeds are placed directly into the prostate. The other is ultra-hypofractionated radiotherapy, a type of external radiation given in five quick sessions. Both treatments aim to destroy cancer cells and rely on a protective gel to reduce side effects on the bowel. The trial will compare their short- and long-term side effects, such as changes in bladder or bowel habits, or erectile function. The goal is to provide clearer information to help men and their doctors choose the most suitable treatment.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Enrolment target

220

Start

01 Dec 2025

Estimated completion

01 Dec 2030

Prostate Adenocarcinoma

What is this study about?

This clinical trial, called LDR BURST, is looking at two ways to treat localised prostate cancer with radiation. Localised means the cancer is contained within the prostate gland. The first treatment is called 4D low dose rate brachytherapy. This involves carefully placing tiny radioactive seeds directly inside your prostate gland during a minor procedure. These seeds then release radiation slowly over several months to kill the cancer cells. Most men go home on the same day after this treatment.

The second treatment is a type of external radiation called ultra-hypofractionated radiotherapy (also known as Stereotactic Radiotherapy). This uses very precise, high-energy X-rays aimed at your prostate from outside your body. You'll usually have five short treatment sessions, typically on alternate days, meaning the full course is completed within two weeks. Before this treatment, small metallic markers are placed in your prostate to help guide the radiation accurately. The NHS has recently approved this type of treatment due to its proven safety and effectiveness in other trials.

Both treatments aim to destroy prostate cancer cells using radiation. A key part of this trial is a special protective gel called Barrigel. This gel is placed between your prostate and your bowel, creating more space and significantly reducing the amount of radiation your bowel receives. This helps lower the risk of bowel-related side effects. The gel is temporary and naturally disappears from your body over several months. This trial will compare the side effects of these two effective treatments to help specialists understand which might be better for different men.

Key takeaways

The study compares side effects of two radiation treatments for early prostate cancer.
Treatments include radioactive seeds implanted in the prostate or external radiation in 5 sessions.
A protective gel reduces radiation dose to the bowel for both treatments.
Side effects like bladder/bowel issues and erection problems are monitored.
Participation involves random allocation to one treatment and 5 years of follow-up.
The study helps improve future treatment choices for prostate cancer patients.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with low to intermediate-risk prostate cancer. This means your cancer has not spread beyond the prostate and is considered to be at an early stage. You should also be generally well enough to undergo these treatments.

There are a few reasons why you might not be able to join. For example, if you've had other types of cancer recently (apart from some common skin cancers), or if you've had radiation treatment to your pelvic area before. Also, if you're already receiving or need hormone therapy for your prostate cancer, this study might not be suitable for you. The medical team will check details like your PSA level (a blood test for prostate health) and the size of your prostate gland to make sure the trial is right for you.

It's important that you don't have severe bladder or bowel problems that would make radiation treatment difficult, or any medical conditions that limit your life expectancy to less than 10 years. The medical team will discuss all these points with you to see if you meet the specific criteria for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or over?
Do you have low to intermediate-risk prostate cancer?
Have you not had previous radiation treatment to your pelvic area?
Are you generally well and able to undergo treatment?
Are you able to provide consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the treatment you receive will be chosen by chance, like flipping a coin. This means there's an equal 50% chance you'll receive either the radioactive seed implant (brachytherapy) or the external beam radiation (stereotactic radiotherapy). Before starting treatment, you'll complete four questionnaires to help us understand your health and symptoms then. You'll also have a protective gel inserted, either at the same time as the seeds for brachytherapy, or with the metallic markers for external radiation.

After your treatment, you'll be contacted by phone every four weeks for the first two months to check for any side effects. You'll then have a face-to-face appointment at three months, which will include a PSA blood test. After this, you'll have regular follow-up appointments and assessments for a total of five years to monitor your health and any long-term effects. The total duration of active follow-up for this study is five years.

Potential risks and benefits

Taking part in this study means you'll receive one of two established radiation treatments for prostate cancer, both of which are effective. A potential benefit is contributing to medical knowledge, helping future patients and doctors make more informed decisions about prostate cancer treatment. Both treatments carry similar potential side effects, including temporary bladder changes (like needing to urinate more often), bowel changes (more frequent or looser stools, sometimes with a little blood), and possible difficulties with erections, which can often be managed with medication. There's also a very small, long-term risk of developing a new cancer many years later from radiation exposure, which is the same whether you're in the trial or receiving these treatments outside of it. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Surrey NHS Foundation Trust
Verified postcode
Guildford, United Kingdom

Common questions

What is localised prostate cancer?

Localised prostate cancer means the cancer cells are found only within the prostate gland and have not spread to other parts of your body.

What are the common side effects of these treatments?

Common side effects can include needing to urinate more often, slower urine flow, and changes in bowel habits like more frequent or looser stools. Some men may also experience issues with erections, which can often be helped by medication.

What is the Barrigel and why is it used?

Barrigel is a protective gel inserted to create more space between your prostate and bowel during treatment. This significantly reduces the radiation dose to your bowel, lowering the risk of bowel-related side effects. It's temporary and absorbed by your body over a few months.

How will I know which treatment I'll receive?

If you join the trial, the treatment you receive will be chosen randomly, like drawing lots. This means there's an equal chance you'll get either the radioactive seed implants or the external beam radiation.

How long will I be followed up after treatment?

You will be followed up for a total of five years after your treatment, with regular phone calls and appointments to monitor your health and any side effects.

How to find out more

William Hayhurst, Doctor

william.hayhurst@nhs.net +(44)1483 571122 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.