RecruitingPhase IIIInterventional

A randomised Phase III trial to assess whether radiotherapy with radiosensitisers is beneficial in patients with high-risk non-muscle invasive bladder cancer when compared with the standard of care treatment, Bacillus Calmette-Guerin

This study is for people with a type of bladder cancer called high-risk non-muscle invasive bladder cancer. Currently, after surgery, patients usually receive a drug called BCG directly into the bladder. However, for many, the cancer returns or gets worse, and BCG can have side effects or be difficult to get. This research is testing if a different treatment, which combines radiotherapy (radiation treatment) with special medicines (called radiosensitisers), works better than BCG. This combined treatment aims to make the radiotherapy more effective. The study will compare these two approaches to see if the radiotherapy combination can help prevent the cancer from coming back or getting worse, offering a new option for patients.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

The Christie NHS Foundation Trust

Enrolment target

328

Start

30 Apr 2026

Estimated completion

01 Dec 2028

High-risk non-muscle invasive bladder cancer

What is this study about?

In the UK, about 20,000 people are diagnosed with bladder cancer each year, and for most of them (75-80%), the cancer hasn't spread into the bladder muscle. This is called non-muscle invasive bladder cancer (NMIBC). If this type of cancer is considered high-risk, meaning it's more likely to come back or spread, the usual treatment after removing the tumour with surgery involves giving a drug called BCG directly into the bladder. Another option is surgery to remove the whole bladder. However, in up to half of patients, the cancer still returns or gets worse after BCG, and a quarter of patients stop treatment due to side effects. There have also been issues with getting enough BCG supplies globally, which can make things harder for patients.

Because of these challenges, doctors are looking for better treatments. This study is investigating a different approach called 'trimodality treatment' (TMT). TMT combines surgery to remove the tumour with radiotherapy (focused radiation to kill cancer cells) and special drugs called "radiosensitisers." These drugs help make the cancer cells more sensitive to the radiation, potentially making the treatment more effective. While TMT is already used for more advanced bladder cancer that has spread into the muscle, it's not routinely used for the high-risk non-muscle invasive type.

Previous studies have shown promising results for TMT in high-risk NMIBC, with many patients remaining cancer-free for several years. This new study aims to rigorously test whether this combination of modern radiotherapy and radiosensitiser drugs works better than the standard BCG treatment for people with high-risk non-muscle invasive bladder cancer. By doing so, we hope to find a new treatment that is more effective at preventing the cancer from returning or getting worse, improving outcomes for patients.

Key takeaways

Compares standard treatment (BCG) to a new radiotherapy approach for high-risk bladder cancer.
Aims to find a better way to prevent cancer recurrence and progression.
The new therapy combines precise radiation with special drugs to boost effectiveness.
You'll be randomly assigned to one of the two treatment groups.
Participation involves treatment and at least two years of follow-up.
Looks for a treatment that's more effective with fewer side effects or supply issues than current options.

Who may be eligible?

This study is looking for people who are 16 years old or older and have been diagnosed with high-risk non-muscle invasive bladder cancer. This means the cancer is serious but hasn't spread into the bladder muscle.

To join, you must have already had surgery to remove the tumour and be considered suitable for both the standard treatment (BCG) and the experimental treatment (radiotherapy with radiosensitisers). You also need to be in reasonably good health with a life expectancy of over 12 months and provide your written agreement to take part.

There are some reasons why you might not be able to join. For example, if your doctors have already strongly recommended removing your bladder, or if you've had pelvic radiotherapy or bladder treatments very recently. You also can't take part if you're pregnant or breastfeeding, or if you have certain other serious health conditions or are currently in another medical 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 16 years old or older?
Do you have high-risk non-muscle invasive bladder cancer?
Have you had surgery to remove the tumour?
Are you generally healthy enough for both BCG and radiotherapy treatments?
Are you able to use effective contraception if needed during and after the study?
Have you NOT had previous pelvic radiotherapy or bladder treatments recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two treatment groups, like flipping a coin. One group will receive the standard treatment: BCG (Bacillus Calmette-Guérin) immunotherapy, given directly into your bladder. The other group will receive the experimental treatment: radiotherapy combined with special drugs called radiosensitisers. The radiotherapy will be given over 20 daily sessions, and the research team will choose one of three different radiosensitiser options for you.

You will have regular check-ups for at least two years to see how well the treatment is working and to monitor any side effects. During these follow-up visits, you might also be asked to provide extra blood samples from a vein. The total duration of your participation will include the treatment period and the minimum two-year follow-up.

Potential risks and benefits

By taking part, you could potentially benefit from a new treatment approach that might be more effective than current standard care, especially if the new radiotherapy-based treatment proves more successful in preventing cancer recurrence or progression. However, like all medical treatments, there are potential risks. The main risks expected are possible side effects from the radiosensitiser drugs and the radiotherapy. These will be fully explained in a patient information sheet, and the research team will monitor you closely to manage any side effects. Providing extra blood samples may cause temporary discomfort, bruising, or a small risk of infection. You have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (10)

The Christie
Approximate
Manchester, England
Rosemere Cancer Centre
City only
Preston, England
Royal Lancaster Infirmary
Approximate
Lancaster, England
Royal Surrey County Hospital
Approximate
Guildford, England
Royal Surrey County Hospital
Approximate
Guildford, England
Diana, Princess of Wales Hospital
Unverified
Grimsby, England
Stepping Hill Hospital
Unverified
Stockport, England
University Hospital Ayr
Unverified
Ayr, Scotland
Peterborough City Hospital
Unverified
Peterborough, England
Wycombe Hospital
Unverified
High Wycombe, England

Common questions

What is 'high-risk non-muscle invasive bladder cancer'?

It's a type of bladder cancer that hasn't spread into the bladder muscle, but it's considered serious because it has a higher chance of coming back or getting worse.

What is BCG and how is it usually given?

BCG (Bacillus Calmette-Guérin) is a drug given directly into the bladder after surgery, typically once a week for six weeks, followed by maintenance doses for up to three years. It's an immunotherapy that helps your body fight the cancer.

What are 'radiosensitisers'?

These are special medicines designed to make cancer cells more sensitive to radiotherapy, helping the radiation treatment work more effectively to kill the cancer cells.

How long will the study last for me?

You will be followed up for at least two years after your treatment ends, so the total time will include your treatment period plus this minimum follow-up.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), which is a major health research funder in the UK.

How to find out more

Daniel Griffiths

train@soton.ac.uk - Official trial record

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