RecruitingNAINTERVENTIONAL

Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions

This study, called "DESTINATION 2," is for men with a type of prostate cancer that hasn't spread. It's testing a new way of giving radiotherapy in only two sessions, using advanced MRI scanning to guide treatment. Half the men will receive a standard dose to the whole prostate, while the other half will get a lower dose to healthy tissue and a higher dose directly to the tumour. We're mainly looking to see if this new approach can lower the chance of side effects like needing to pee more often or having discomfort in that area. We'll also check how well it controls the cancer and how you feel generally.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

20 Jan 2025

Estimated completion

01 Jan 2027

Prostate Cancer

What is this study about?

Imagine you have prostate cancer that hasn't spread, and your doctor suggests radiotherapy. Usually, this means many visits over several weeks. This study, called DESTINATION 2, is looking at a much shorter way to give this treatment – just two sessions!

This is possible thanks to a very clever machine called an MR-Linac. This machine uses powerful magnets, like those in an MRI scan, to take detailed pictures of your body *while* you're having radiotherapy. This means the doctors can see exactly where your prostate and the tumour are each day, and make tiny adjustments to the treatment to hit the cancer more precisely. Because they can be so accurate, they might be able to give higher doses in fewer sessions.

In this study, some men will receive the radiotherapy dose evenly across their prostate and nearby areas where cancer cells might be. Other men will try a new approach where the healthy parts of the prostate get a slightly lower dose, but the area where the tumour is actually seen on the MRI gets a higher, more targeted dose. The main goal is to see if this 'smart targeting' can reduce the side effects you might experience while still being effective against the cancer. We also want to understand your experience and how well the treatment works in the long run.

Key takeaways

Tests a two-session radiotherapy for prostate cancer.
Uses advanced MRI-guided treatment (MR-Linac).
Compares uniform dose to a targeted, 'de-escalated' dose.
Aims to reduce side effects while controlling cancer.
Includes follow-up for up to two years.

Who may be eligible?

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer that hasn't spread. Your cancer should be of a certain type and grade (Gleason 3+3, 3+4 or 4+3) and visible on an MRI scan. We also need to make sure you're generally well enough to take part and can understand what's involved.

There are some reasons why you might not be able to join. For example, if you have a pacemaker or other metal implants that make MRI scans unsafe, or if you have very severe bladder or bowel problems. Your prostate size also needs to be within a certain range. The study team will check all these details carefully with you and your doctor.

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 older?
Do you have prostate cancer that hasn't spread (localised)?
Is your cancer of a specific type and grade (Gleason 3+3, 3+4 or 4+3)?
Is your tumour visible on an MRI scan?
Are you generally well and able to have an MRI scan?

Answer every question to see your result.

What does participation involve?

If you decide to join, you'll first be checked to make sure you meet all the requirements. Then, you'll be randomly assigned to one of two treatment groups – like flipping a coin for which treatment plan you'll get, so neither you nor your doctor can choose. All participants will receive their radiotherapy in just two sessions using the special MR-Linac machine.

After your treatment, you'll have appointments to check on you, assess any side effects, and complete questionnaires about your well-being. These check-ups will happen at 4 and 12 weeks, then at 6 months, 1 year, and 2 years after your treatment. We’ll also check your PSA (Prostate-Specific Antigen) levels, which can indicate how well the cancer is being controlled. The total duration of your participation in terms of follow-up will be about two years.

Potential risks and benefits

Participating in this study might offer the benefit of a much shorter radiotherapy treatment for your prostate cancer, reducing the number of hospital visits. The new targeted approach might potentially lead to fewer side effects, though this is what the study aims to find out. Like all medical treatments, there are potential risks, including side effects from the radiotherapy such as changes in how your bladder or bowel work, or temporary discomfort. These will be carefully monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Not yet recruiting
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is an MR-Linac?

It's a special machine that combines an MRI scanner with a radiotherapy machine, allowing doctors to see the cancer very clearly and adjust the treatment in real-time.

How many treatment sessions will I have?

All participants in this study will have their radiotherapy delivered in just two sessions.

Will I know which treatment I'm getting?

No, you'll be randomly assigned to one of the two treatment groups, meaning it's decided by chance, like drawing lots.

What kind of side effects are you looking for?

We are mainly watching for side effects related to your bladder and bowels, like needing to pee more often, and also generally how you are feeling after treatment.

Can I take part if I'm already on hormone therapy?

Yes, if your doctor thinks hormone therapy (like ADT) is right for you, you can still participate in the study.

How to find out more

Francesca Mason

mrltrials@rmh.nhs.uk +44 20 3186 5157 Official trial record

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