RecruitingOBSERVATIONAL

Selecting Hypoxic Tumours for Treatment Modification

This research is looking into how we treat certain bladder and prostate cancers. About half of cancer patients have radiotherapy, but some tumours are 'hypoxic' – meaning they have low oxygen levels – and don't respond well. Doctors want to find these hypoxic tumours early so they can give a stronger or different type of treatment, like adding oxygen-rich air or certain medicines, to make the radiotherapy work better. Currently, there isn't a good test to find these specific tumours. Our team has developed new tests based on studying genes in cancer cells, and we want to show that these tests can accurately predict which patients will benefit from these special treatments in real-time, helping more people get the most effective care.

At a glance

Status

Recruiting

Sponsor

University of Manchester

Enrolment target

Start

16 Oct 2024

Estimated completion

30 May 2028

Bladder (Urothelial, Transitional Cell) Cancer Prostate Cancer

What is this study about?

You might be reading this because you, or someone you know, has been diagnosed with bladder or prostate cancer. Often, one of the main treatments for cancer is radiotherapy, which uses high-energy rays to kill cancer cells. While radiotherapy works very well for many people, we know that some tumours don't respond as well as others. This can be due to a characteristic called 'hypoxia', which means the tumour has areas with very low oxygen levels. These hypoxic tumours are tougher to treat and can unfortunately lead to poorer outcomes for patients.

Researchers are working hard to find better ways to identify these hypoxic tumours. If doctors know a tumour is hypoxic, they can potentially change the treatment plan to make it more effective. This could involve things like giving special oxygen-enriched air to breathe, using certain medications that make cancer cells more sensitive to radiotherapy, or giving a slightly higher dose of radiation. These modified treatments have been shown to significantly improve how well the tumour responds to radiotherapy. However, the challenge is that we don't currently have a standard, reliable test to easily identify which tumours are hypoxic.

That's where this study comes in. Our team has developed new tests that look at the genes within a tumour. These 'gene-expression signature' tests can spot the patterns that indicate a tumour is hypoxic. We've already shown that these tests work on stored tumour samples for several cancer types, including bladder and prostate cancer, and that the bladder test can even predict who might benefit from modified treatments. The main goal of this study is to prove that these new gene-based tests can accurately identify hypoxic tumours in patients right now, as part of their care, so doctors can quickly make the best treatment choices and give patients the best chance of successful treatment.

Key takeaways

This study aims to improve radiotherapy for bladder and prostate cancers.
It focuses on finding 'hypoxic' (low oxygen) tumours that are often harder to treat.
Researchers are testing a new gene-based test to identify these tumours.
The goal is to help doctors choose the most effective treatment for each patient.
Participation involves an MRI scan and tissue sample (often from routine care).

Who may be eligible?

This study is looking for adult patients who have bladder or prostate cancer and are planning to have radiotherapy at The Christie NHS Foundation Trust.

To be considered, you must be aged 18 or older and be able to have an MRI scan. You'll also need to be able to understand the study and agree to take part by signing a consent form.

There are also some reasons why you might not be able to join. These include if you have any issues that would make an MRI scan unsafe for you (like certain metal implants), or if you wouldn't be able to stay still for the scan. If you are pregnant, you would also not be able to take part.

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 18 years old or older?
Do you have bladder or prostate cancer?
Are you planning to have radiotherapy at The Christie NHS Foundation Trust?
Are you able to have an MRI scan?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your planned radiotherapy treatment at The Christie NHS Foundation Trust. The main part of your involvement will be having an MRI scan. We will also need to get a sample of your tumour tissue. This might be a biopsy that is already planned as part of your normal care, or a small additional sample might be taken. This tissue will be used for the gene-expression tests that help us understand if your tumour is hypoxic. The study team will explain everything in detail, including how long each part will take and what to expect during any scans or procedures. You won't be given any new treatments purely for this study; the aim is to use the new test to help guide existing treatment options. The total length of your participation will depend on your individual treatment plan and follow-up.

Potential risks and benefits

Taking part in this study could potentially help us learn more about tailoring cancer treatments, which might benefit future patients. For you, the main benefit is that if the new test identifies your tumour as hypoxic, your doctor might be able to adjust your treatment to make it more effective. The main risks involved relate to the MRI scan (for example, slight discomfort or rare reactions if contrast dye is used, though safety checks are done) and obtaining a tumour tissue sample, which carries small risks of bleeding or infection, similar to any biopsy. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What does 'hypoxic tumour' mean?

It means the tumour has areas with very low oxygen levels, which can make it harder for radiotherapy to work effectively.

Will taking part change my cancer treatment?

The aim is for the new test to help your doctors decide if a modified treatment approach would be better for your specific tumour. It won't mean you get an experimental treatment.

What is a 'gene-expression signature'?

It's a special test that looks at the patterns of activity in certain genes within your tumour cells to identify specific characteristics, like being hypoxic.

Do I have to live near The Christie NHS Foundation Trust to take part?

Yes, you need to be receiving your radiotherapy treatment at The Christie NHS Foundation Trust to be eligible for this study.

Is the new test safe?

The gene-expression test uses a small tissue sample, similar to regular biopsies. The research aims to make this test a standard, safe part of future care.

How to find out more

Rachel Reed, MSc

rachel.reed@manchester.ac.uk 01619184780 Official trial record

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