Active not recruitingOBSERVATIONAL

Using Breath, Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT

This research wants to make radiotherapy for prostate cancer as effective and gentle as possible. Currently, everyone gets a similar dose, but people respond differently. This study explores new ways to predict how each person's body and cancer will react to treatment in real-time. Over a 5-day course of a special type of radiotherapy called SBRT, we'll be looking at three things: chemicals in your breath, tiny bits of DNA in your blood, and detailed scans of your rectum. The idea is that these 'biomarkers' could help doctors choose the best dose for you, aiming to destroy the cancer while minimising side effects. We'll compare these new methods with standard ways of checking progress, like PSA levels and patient-reported well-being, over two years.

At a glance

Status

Active not recruiting

Sponsor

NHS Lothian

Enrolment target

Start

11 Oct 2018

Estimated completion

30 Jun 2026

Prostate Cancer Radiotherapy Side Effects Volatile Organic Compounds DNA Damage

What is this study about?

When you have radiotherapy for prostate cancer, the aim is to kill cancer cells, but it can sometimes affect healthy tissues nearby. Currently, the dose of radiotherapy is generally the same for everyone, but we know that each person's body responds differently. This can mean that some people experience more side effects, while for others, the treatment might not be as effective as it could be.

This study is trying to find ways to make radiotherapy much more personal. The idea is to understand how your body and the cancer are reacting to treatment as it's happening, so that in the future, doctors could adjust the treatment specifically for you. This could mean a better chance of getting rid of the cancer and fewer side effects. We're focusing on a type of radiotherapy called Stereotactic Body Radiotherapy (SBRT), which is given in just 5 short treatment sessions.

To do this, we're exploring three different approaches. Firstly, we're looking at your breath – we believe tiny chemical signals in your breath could give us clues about how your body is responding to the treatment. Secondly, we'll examine small fragments of DNA in your blood, which could tell us about both the cancer's reaction and how your healthy tissues are coping. Finally, we'll use advanced computer analysis on routine scans taken before and after each treatment to look for early signs of how your rectum, which is near the prostate, is responding. All these methods will be compared with standard ways of tracking your progress, such as PSA blood tests and surveys about your quality of life, over a period of up to two years.

Key takeaways

Aims to make prostate radiotherapy more personalised.
Looks at breath, DNA, and scans to predict treatment response.
Focuses on a 5-day course of Stereotactic Body Radiotherapy (SBRT).
Goal is to improve cure rates and reduce side effects.
Involves collecting extra breath and blood samples, and analysing scans.
Follow-up for up to 2 years to track progress and side effects.

Who may be eligible?

This study is looking for men aged between 18 and 80 who have been diagnosed with prostate cancer. Your cancer should be either low-risk or intermediate-risk, meaning it hasn't spread widely and has specific PSA and Gleason scores.

To be suitable, you need to generally be in good health, with an acceptable 'WHO performance status'. We also need to check your prostate size, how well you empty your bladder (measured by 'International Prostate Symptom Score' and 'peak urinary flow rate'), and if you have any leftover urine after peeing.

There are also some things that would mean you couldn't join. For example, if you've had certain bowel conditions like inflammatory bowel disease, or if you've had specific prostate procedures like a 'Trans Urethral Resection of the Prostate (TURP)' or previous radiotherapy to your pelvis, or a history of urinary retention. You also shouldn't have received previous hormone treatment for your prostate cancer.

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 between 18 and 80?
Do you have low-risk or intermediate-risk prostate cancer?
Are you generally in good health?
Have you *not* had inflammatory bowel disease or previous pelvic radiotherapy?
Have you *not* had specific prostate surgery (TURP) or previous hormone therapy?
Are you able to provide informed consent?

Answer every question to see your result.

What does participation involve?

If you agree to take part, you will receive 5 short radiotherapy treatments as part of this study. During each treatment session, we will collect a breath sample using a special device. We will also take blood samples at the start, during, and after your treatment course. Regular scans (called Cone Beam CTs) that are normally taken during SBRT to check the treatment area will also be analysed for the study. After your treatment, you will have follow-up appointments, where we will check your PSA levels and ask you to complete questionnaires about your quality of life and any side effects. These follow-up assessments will continue for up to 24 months (2 years) after your radiotherapy ends. The total duration of your involvement will be from the start of your treatment until your final follow-up at 2 years.

Potential risks and benefits

Taking part in this study could potentially help us learn more about tailoring prostate cancer treatment, which could benefit future patients by making radiotherapy more effective and reducing side effects. However, there's no guarantee it will directly benefit you personally. You will have additional breath and blood samples taken beyond your standard care. While these procedures are generally safe, there are minor risks associated with blood draws, such as bruising or discomfort. All radiotherapy treatments carry potential side effects, and while this study aims to understand and reduce them, these risks remain. Please remember that participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your standard medical care.

Locations (1)

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

Edinburgh Cancer Centre, Western General Hospital
Verified postcode
Edinburgh, United Kingdom

Common questions

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's an advanced type of radiation treatment that delivers very high doses of radiation to a precise area, like the prostate, over fewer treatment sessions compared to traditional radiotherapy.

What are 'volatile organic compounds'?

These are tiny chemical signals that are naturally released in your breath. Scientists believe they can act like a 'fingerprint' that tells us about what's happening inside your body, including how it's responding to treatment.

What is 'cell-free DNA'?

Cell-free DNA are small pieces of DNA that circulate freely in your bloodstream. Both healthy cells and cancer cells release DNA when they die, and by looking at these fragments, we might learn about how the cancer and your normal tissues are reacting to radiotherapy.

Will my treatment be different if I join the study?

Your radiotherapy treatment (SBRT) will be delivered as planned by your medical team. The study involves collecting extra information, such as breath samples and blood samples, and analysing routine scans in a new way, but it will not change the actual radiation you receive during this pilot phase.

How long will I be involved in the study?

Your active involvement with treatment and sample collection will be during your 5-day SBRT course. After that, we'll continue to check your progress with follow-up appointments, including PSA tests and questionnaires, for up to 2 years.