RecruitingNot ApplicableObservational

SpaceOAR post-market registry study

This study is checking the long-term safety of a product called SpaceOAR. SpaceOAR is a special gel placed between the prostate and the back passage (rectum) during prostate cancer radiotherapy. It helps reduce radiation exposure to the rectum, which can lower side effects. While SpaceOAR has been used for years, regulators want more information on its long-term safety. If you're a man aged 18 or over with prostate cancer, having radiotherapy, and are already getting SpaceOAR as part of your treatment, you might be asked to join. The study involves answering questions about your health and quality of life for up to three years, mainly online or by post.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

228

Start

24 Nov 2025

Estimated completion

01 Mar 2027

Prostate cancer

What is this study about?

This study, called the SpaceOAR post-market registry study, is all about understanding the long-term safety of a device used in prostate cancer treatment. When men have radiotherapy for prostate cancer, there's a risk that the radiation might affect nearby healthy organs, like the back passage (rectum). This can lead to unwanted side effects.

To help reduce this risk, a special gel called SpaceOAR (or SpaceOAR Vue) can be used. It's a biodegradable gel, meaning it naturally breaks down over time, and it's placed between the prostate and the rectum. This creates a small space, pushing the rectum away from the prostate so it receives less radiation. While SpaceOAR has been safely used for several years, regulators want to gather more information on its effects over a longer period.

This study aims to collect important information about how men who receive SpaceOAR are doing, both in the short-term and over several years. This data will help doctors and regulators better understand the full picture of SpaceOAR's safety, ensuring it continues to be a good option for future patients undergoing prostate cancer treatment. Your participation would contribute greatly to this important understanding.

Key takeaways

The study investigates the long-term safety of SpaceOAR gel used in prostate cancer radiotherapy.
It's for men aged 18+ with prostate cancer, having radiotherapy, and already receiving SpaceOAR.
Participation involves completing health and quality of life questionnaires for up to 3 years.
Most questionnaires are completed remotely (online or by post).
Hospital follow-up will continue for an extra year compared to standard care.
There are no direct personal benefits or new risks from participating in the study.

Who may be eligible?

This study is for men who have been diagnosed with prostate cancer and are planning to have radiotherapy treatment. To be able to join, you must be aged 18 or older.

Importantly, you can only take part if your medical team has already decided that you will receive a SpaceOAR gel spacer as part of your regular, planned treatment. This study is not about trying out SpaceOAR for the first time, but observing its long-term effects in patients who are already going to have it.

You cannot take part if you are unable to understand the study information or communicate clearly, for example, if you have difficulty understanding spoken English or written materials.

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?
Have you been diagnosed with prostate cancer?
Are you planning to have radiotherapy for your prostate cancer?
Has your doctor recommended that you receive a SpaceOAR or SpaceOAR Vue gel spacer as part of your planned treatment?
Can you understand information about the study in English?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it won't change your medical treatment itself – you'll still receive your SpaceOAR and radiotherapy as planned. What will be different is that you'll be asked to complete some questionnaires over a period of up to three years (36 months) from when you have your SpaceOAR inserted.

These questionnaires will ask about your health and different aspects of your quality of life related to your prostate cancer treatment. Most of the time, you'll be able to complete these questionnaires from home, either online or through the post if you prefer. You'll fill them out when you first agree to join, then again at about 75 days, and at 6, 12, 24, and 36 months after your SpaceOAR is put in.

Another aspect of taking part is that your hospital follow-up appointments, which normally might finish around 24 months after your treatment, would continue for an extra year, up to 36 months. This allows the study to collect more long-term information. The study will end for you after your 36-month visit and when you complete your final questionnaire.

Potential risks and benefits

You won't get any direct physical benefit from taking part in this study. However, by sharing your health journey, you will be helping to improve medical knowledge and potentially benefit future patients who receive SpaceOAR. Taking part will also mean you'll have follow-up appointments for a slightly longer period (up to 3 years) than standard care, which some may see as an added benefit. The good news is that we don't expect any extra risks to you specifically from joining this study. You also have the right to withdraw from the study at any time without affecting your medical care.

Locations (8)

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

Chesterfield Royal Hospital NHS Foundation Trust
City only
Chesterfield, England
Maidstone and Tunbridge Wells NHS Trust
City only
Maidstone, England
East and North Hertfordshire Teaching NHS Trust
City only
Stevenage, England
Royal Free London NHS Foundation Trust
City only
London, England
Guy's and St Thomas' NHS Foundation Trust
City only
London, England
The Clatterbridge Cancer Centre NHS Foundation Trust
Unverified
Wirral, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
Unverified
Norwich, England
Burnley General Hospital
Unverified
Burnley, England

Common questions

What is SpaceOAR?

SpaceOAR is a special gel placed during prostate cancer radiotherapy to protect the back passage (rectum) from radiation, which can help reduce side effects.

Why is this study happening?

Regulators want more information about the safety of SpaceOAR gel over a longer period of time, even though it's been used safely for years.

Will my treatment change if I join?

No, your medical treatment for prostate cancer will stay exactly the same. You'll still receive SpaceOAR and radiotherapy as planned.

How long will I be in the study?

You'll be asked to complete questionnaires and attend follow-up appointments for up to three years (36 months) after your SpaceOAR is inserted.

Do I have to go to extra hospital visits?

Most questionnaires can be done remotely (online or by post). Your hospital follow-up appointments will continue for an extra year, up to 36 months, which is longer than usual care.

How to find out more

Said Ibeggazene

said.ibeggazene@nhs.net +44 (0)1142255562 Official trial record

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