RecruitingNAINTERVENTIONAL

Dose De-escalation in Prostate Radiotherapy Using the MRL

This study is investigating a new, shorter radiotherapy treatment for men with intermediate-risk prostate cancer. It uses a special machine called an MR-linac, which combines an MRI scanner with a radiotherapy machine. The main goal is to see if giving a slightly lower, more targeted dose of radiotherapy in fewer sessions is technically possible and helps reduce side effects on the bowel and bladder. Researchers will also check how well the treatment controls the cancer by measuring PSA levels. Participants will receive five radiotherapy treatments over a short period. This is an important step to find more effective and patient-friendly ways to treat prostate cancer.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

01 Mar 2023

Estimated completion

01 Mar 2027

Prostate Adenocarcinoma

What is this study about?

This study is looking at a new approach to radiotherapy for men who have prostate cancer that is considered 'intermediate risk.' This means their cancer has certain features that put it in a middle category between very low-risk and high-risk cancers.

The main idea behind this research is to see if a special type of radiotherapy, delivered using a machine called an MR-linac, can be given in fewer treatment sessions and with fewer side effects. The MR-linac is a very advanced machine that combines an MRI scanner with a radiotherapy device. This allows doctors to see the prostate and surrounding organs very clearly during treatment, helping them target the cancer more precisely and protect healthy tissues like the bowel and bladder.

The study will specifically check if this new way of giving radiotherapy is 'technically feasible' – meaning, can it be done safely and effectively using the MR-linac? They will also closely monitor any side effects on the bowel and bladder, both during and after treatment, and assess how well the treatment controls the cancer by looking at Prostate-Specific Antigen (PSA) levels for up to two years.

Key takeaways

New radiotherapy technique for intermediate-risk prostate cancer.
Uses an advanced MR-linac machine for precise targeting.
Aims to reduce treatment sessions and side effects.
5 radiotherapy treatments in total.
Careful monitoring of side effects and cancer control for two years.

Who may be eligible?

This study is looking for men aged 18 or over who have been diagnosed with prostate cancer that needs radiotherapy. Your cancer should be of an 'intermediate risk' type, and MRI scans shouldn't show it has spread beyond the prostate or is too large.

There are also some specific medical conditions that might mean you can't take part. For example, if you have certain metal implants like a pacemaker that aren't safe for MRI scans, or if you've had radiotherapy to your pelvis before. Your general health and ability to complete questionnaires are also important.

If you're currently taking hormone therapy (ADT), you might still be able to join, depending on the type and duration. It's best to discuss all your medical history and any conditions you have with your doctor to see if this study could be right for you.

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 intermediate-risk prostate cancer requiring radiotherapy?
Do you have a clear MRI-visible tumour that isn't too large?
Do you not have medical implants that prevent MRI scans?
Have you not had previous radiotherapy to your pelvis?
Can you complete questionnaires about your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive your radiotherapy treatment on the special MR-linac machine. The treatment involves a total of 5 short sessions given over a period of time, usually within one to two weeks. During each session, you'll lie on the MR-linac machine while the treatment is delivered. The whole prostate gland will receive one dose of radiotherapy, and any specific areas within the prostate where the cancer is most visible will receive a slightly higher, more targeted dose.

After your radiotherapy, you'll have follow-up appointments where doctors will check your progress and monitor for any side effects. You'll also be asked to fill out questionnaires about how you're feeling and any symptoms you experience. Researchers will check your PSA levels regularly for up to two years to see how well the cancer is being controlled. The total duration of active follow-up for the study is two years.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new, potentially more precise radiotherapy treatment that aims to reduce side effects. This approach could lead to a shorter overall treatment course. However, as with any medical treatment, there are potential risks. Radiotherapy can cause side effects, though this study specifically aims to reduce them, and researchers will carefully monitor your bowel and bladder health. You will undergo regular MRI scans, and some people may not be suitable for MRI due to certain medical implants or claustrophobia. Your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

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

The Royal Marsden Hospital
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 precisely see and target the cancer during treatment.

How many radiotherapy sessions will I have?

You will have 5 radiotherapy sessions in total, delivered over a short period.

What kind of cancer is this study for?

It's for men with intermediate-risk prostate cancer that needs radiotherapy.

Will I still need hormone therapy?

You might be able to take part if you are on certain types of hormone therapy, depending on your situation. Your doctor will advise you.

What will doctors be checking after my treatment?

They will monitor your health, look for any side effects, and check your PSA levels for up to two years to see how well the treatment is working.

How to find out more

Alison Tree, MBBS

alison.tree@icr.ac.uk 02086613269 Official trial record

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