RecruitingNAINTERVENTIONAL

Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer

This research is looking at new ways to treat prostate cancer using a type of targeted X-ray therapy called SBRT. SBRT delivers powerful radiation doses directly to the prostate in fewer sessions. We want to see if giving this treatment in just 2 sessions over 8 days works as well and has similar side effects to the current 5-session treatment over 10 days. All treatments will be given on a very modern machine called an MR-linac. This machine combines an MRI scanner with the radiation equipment, allowing doctors to see the prostate very clearly and adjust the treatment daily for better accuracy. The main aim is to find out if the shorter, 2-dose treatment is safe and effective enough for future use.

At a glance

Status

Recruiting

Phase

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

29 Jul 2021

Estimated completion

30 Apr 2028

Prostate Cancer

What is this study about?

This study is an important step in finding better and potentially quicker ways to treat prostate cancer. Currently, a common treatment involves focused X-ray therapy, called SBRT, given in five sessions over about a week and a half. This trial wants to see if we can achieve the same good results and keep side effects low by giving the treatment in just two sessions, spread over eight days.

To do this, we'll be using a very advanced piece of equipment called an MR-linac. Imagine an MRI scanner and a radiation treatment machine joined together. This special machine lets doctors see your prostate clearly during treatment without using extra X-rays. This means they can be very precise, making sure the radiation hits only the cancer cells and spares healthy tissue as much as possible. It also allows them to adjust the treatment every day if needed, based on tiny changes in your body.

We already have a lot of experience with the five-treatment approach. Now, we're carefully exploring if the shorter, two-treatment option is just as safe and works just as well. If successful, this could mean fewer hospital visits and less disruption to your life while still effectively treating prostate cancer.

Key takeaways

This study compares 2 vs. 5 X-ray treatment sessions for prostate cancer.
It uses a new, precise MR-linac machine for accurate targeting.
The aim is to find a shorter, equally safe treatment option.
Participants will also receive hormone therapy.
The study monitors side effects of the new, shorter treatment.

Who may be eligible?

This study is for men aged 18 or older who have been diagnosed with prostate cancer that needs focused X-ray therapy. Your doctor will have identified your cancer as either Gleason score 3+4 or 4+3, and it should not have spread too far. Your PSA level should be below 25, and you must be taking hormone therapy for at least six months alongside the X-ray treatment. You should also be generally well enough to take part and able to understand and agree to the study details.

There are some reasons why you might not be able to join. For example, if you have certain medical devices like a pacemaker or other metal implants that make MRI scans unsafe, or if you have severe claustrophobia. We also can't include you if you have significant bladder problems, a very large prostate, or other serious health issues that might make the treatment risky. If you've had previous radiation to your pelvis, or if you need hormone therapy for a very long time (2-3 years), you wouldn't be suitable either. Finally, certain previous cancers could also prevent eligibility.

Quick self-check

Are you a man aged 18 or over?
Do you have prostate cancer that your doctor has said needs X-ray treatment?
Is your prostate cancer in a specific range (Gleason 3+4 or 4+3, T3a or less, PSA under 25)?
Are you currently receiving (or about to start) at least 6 months of hormone therapy?
Do you generally feel well and able to attend appointments?
Do you have any conditions that would make an MRI scan unsafe (like a pacemaker)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll receive your prostate cancer treatment using a special MR-linac machine. The main difference in the study is whether you receive your focused X-ray therapy in two sessions or five sessions. Both options are given over a short period. Throughout the study, you'll have regular check-ups and will be asked to complete questionnaires about your health and any side effects you experience. These questionnaires help us understand how you're feeling and how well the treatment is working. We don't have details on the exact number of visits or the total length of follow-up in this summary, but these details would be explained fully by your study team.

Potential risks and benefits

Participating in this study might offer you a chance to receive a potentially shorter and equally effective prostate cancer treatment using very advanced technology. However, like all medical treatments, there are potential risks, and we are specifically monitoring for side effects with the new, shorter treatment schedule. You will be closely monitored for any issues. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

The Royal Marsden Nhs Foundation Trust
Sutton, United Kingdom· Recruiting

Common questions

What is SBRT?

SBRT is a highly focused type of X-ray treatment that delivers a strong dose of radiation directly to the cancer in fewer treatment sessions than standard radiation.

What is an MR-linac?

The MR-linac is a new, special machine that combines an MRI scanner with the radiation equipment. This allows doctors to see your prostate very clearly during treatment and aim the X-rays more accurately.

Will I still need hormone therapy?

Yes, if you join this study, you will also be receiving hormone therapy, which is a standard part of treatment for prostate cancer alongside the X-ray therapy.

What are the main differences between the two treatments being tested?

The only difference is the number of X-ray sessions: either two sessions over 8 days or five sessions over 10 days. Both use the same advanced MR-linac machine.

What happens if I decide I don't want to continue in the study?

You can withdraw from the study at any time without giving a reason. This won't affect the care you receive for your prostate cancer.

How to find out more

Stephanie Burnett, BSc (Hons)

hermes@icr.ac.uk 02087224261 Official trial record

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