Not yet recruitingPHASE3INTERVENTIONAL

A Phase III Randomised Control Clinical Trial of Radiotherapy With Radiosensitisation Versus Intravesical Bacillus Calmette-Guerin Therapy for High-risk Non-muscle Invasive Bladder Cancer.

If you have a type of bladder cancer called high-risk non-muscle invasive bladder cancer, this study might be for you. It's comparing the usual treatment, which involves a medicine called BCG put directly into the bladder, with a new approach. The new approach combines radiotherapy (X-rays to kill cancer cells) with another medication designed to make the radiotherapy more effective. Doctors are looking for better ways to treat this type of bladder cancer because the current BCG treatment doesn't always work and its supply can sometimes be difficult. This study hopes to find a treatment that helps prevent the cancer from coming back or getting worse, while also reducing side effects.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

The Christie NHS Foundation Trust

Enrolment target

328

Start

01 Dec 2025

Estimated completion

01 Dec 2031

High-Risk Non-Muscle Invasive Bladder Cancer

What is this study about?

This study is looking for better ways to treat a specific type of bladder cancer called 'high-risk non-muscle invasive bladder cancer'. This means the cancer is in the lining of the bladder but hasn't spread deep into the muscle wall. In the UK, many people are diagnosed with bladder cancer each year, and most have this non-muscle invasive type.

Currently, if you have this high-risk cancer, you usually have surgery to remove the tumour, followed by a medicine called BCG that's put directly into your bladder. Another option is surgery to remove the whole bladder. However, BCG treatment doesn't work for everyone – for about half of patients, the cancer comes back or gets worse. Also, some people stop treatment because of side effects, and sometimes there are problems getting enough BCG medicine.

That's why doctors are exploring a different treatment called 'trimodality treatment' (TMT). This involves surgery, followed by radiotherapy (which uses X-rays to target cancer cells) and a special drug to help the radiotherapy work better. TMT is already used for bladder cancers that have spread deeper into the muscle. This study wants to see if this combined radiotherapy approach is better than BCG for people with high-risk non-muscle invasive bladder cancer. It aims to see if it can stop the cancer from returning or worsening, and potentially avoid the need to remove the bladder.

Key takeaways

This study compares standard BCG treatment with a new radiotherapy approach for high-risk bladder cancer.
It aims to find better treatments that prevent cancer recurrence and progression.
Participation involves being randomly assigned to one of two treatment groups.
All participants will have long-term follow-up for at least two years.
The study seeks to address issues with current treatments, including BCG effectiveness and supply.

Who may be eligible?

This study is for adults aged 16 or older who have been diagnosed with a high-risk type of non-muscle invasive bladder cancer. You must be well enough for both the standard BCG treatment and the radiotherapy and special drug treatment being studied. Doctors will also check that you're generally healthy enough to participate, with a life expectancy of more than a year.

There are certain reasons why you might not be able to join. For example, if your doctors have already decided that removing your bladder is the best option for you, or if you've had radiotherapy on your pelvis before. You also can't have serious bladder problems, another active cancer (excluding some minor skin or prostate cancers), or be pregnant or breastfeeding. If you're already in another study or have been in one very recently, you might not be eligible either.

Quick self-check

Have you been diagnosed with high-risk bladder cancer that hasn't spread into the muscle?
Are you generally healthy enough to receive both BCG and radiotherapy treatments?
Are you at least 16 years old?
Have you NOT had radiotherapy to your pelvic area before?
Are you NOT currently pregnant or breastfeeding?

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

What does participation involve?

If you decide to join, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive the standard BCG treatment put into the bladder. The other group will receive radiotherapy (X-ray treatment) along with a special drug to improve its effects. The radiotherapy will involve 20 treatment sessions.

All participants will have their health checked regularly for at least two years after treatment to see how well the treatment worked for them.

Potential risks and benefits

Potential benefits of taking part include access to a new treatment approach that might be more effective than current standard care, especially given the challenges with BCG treatment. However, there's no guarantee the new treatment will be better, and like all medical treatments, there are potential risks and side effects associated with both BCG and radiotherapy. Your doctors will explain these thoroughly. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

The Christie
Manchester, United Kingdom

Common questions

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

It means the cancer is in the lining of your bladder and is considered more likely to spread or come back, but it hasn't grown into the deep muscle layer yet.

What is BCG and how is it given?

BCG is a medicine put directly into your bladder through a small tube. It helps your body's immune system fight the cancer cells.

What is 'radiotherapy with radiosensitisation'?

This is treatment using X-rays to kill cancer cells, combined with a special drug that makes the cancer cells more sensitive to the X-rays, making the treatment more effective.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to either the BCG group or the radiotherapy group, like drawing lots. Neither you nor your doctor can choose.

How long will I be followed up after treatment?

You will be monitored by the study team for at least two years after your treatment to check on your progress and the treatment's effectiveness.

How to find out more

Amber B Cole

train@soton.ac.uk 023 8120 5154 Official trial record

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