SpaceOAR Post-Market Registry Study
This study is gathering important information about the SpaceOAR and SpaceOAR Vue hydrogel systems used by men undergoing radiotherapy treatment for prostate cancer. Medical experts want to understand the short-term side effects and long-term safety of these spacers, especially since more data is needed for regulators. If you're receiving one of these spacers as part of your usual care in the UK or France, you might be asked to take part. Researchers will collect details from your medical records and ask you to complete questionnaires about your experiences. This will help them learn about how the spacer works in real-world settings, how well it's inserted, and any side effects you might have. Your treatment won't change if you join the study.
At a glance
What is this study about?
You might be aware that treatment for prostate cancer often includes radiotherapy. Sometimes, a special gel called a hydrogel spacer, like SpaceOAR or SpaceOAR Vue, is used during this treatment. This gel is placed between the prostate and the rectum to help protect the rectum from the radiation, which can help reduce side effects.
Recently, there have been questions raised by health regulators who want to see more information about how safe these hydrogel spacers are over a long period. This study aims to answer those questions. It will collect information from men who are already having the SpaceOAR or SpaceOAR Vue hydrogel spacer as part of their standard prostate cancer treatment in the UK and France. The aim is to understand both the immediate side effects and the long-term safety of these spacers.
By gathering this information, researchers hope to get a clearer picture of how these spacers perform in everyday medical practice. This will help doctors and patients understand what to expect and ensure that these treatments are as safe and effective as possible for future patients.
Key takeaways
- This study evaluates SpaceOAR/SpaceOAR Vue hydrogel safety for prostate cancer patients.
- It collects data on short-term side effects and long-term safety over 3 years.
- Participation involves sharing medical records and completing questionnaires.
- Your treatment will not change if you take part.
- The study helps improve understanding for future patients.
- It's for men aged 18+ receiving these spacers in the UK or France.
Who may be eligible?
This study is looking for men aged 18 or older who have prostate cancer and are planning to have radiotherapy with the SpaceOAR or SpaceOAR Vue hydrogel spacer. You must be receiving this spacer as part of your normal treatment plan at one of the hospitals taking part in the study in the UK or France.
In the UK, you'll need to be able to understand the study and agree to take part by giving your permission over the phone. In France, you'll need to give written permission by signing a form and also be covered by your country's social security scheme.
If you are unable to understand the study or give your agreement to take part, then you wouldn't be able to join. The medical team will determine if you are able to give consent.
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?
- Do you have prostate cancer and are you planning to have radiotherapy?
- Are you scheduled to have a SpaceOAR or SpaceOAR Vue hydrogel spacer as part of your treatment?
- Are you receiving your treatment at a hospital taking part in this study in the UK or France?
- Are you able to understand the study and provide your agreement to take part?
What does participation involve?
If you decide to take part in this study, your involvement will be quite straightforward because your treatment won't change. Researchers will gather information from your existing medical records. This will include details about your health before the spacer was put in, how the spacer was inserted, your radiotherapy plan, and any other treatments you're receiving.
You will also be asked to complete questionnaires about your experiences and any side effects you have noticed from your treatment. This information will be collected at several points: before the spacer is inserted, when it's put in, at the start of radiotherapy, after radiotherapy, and then at 6 months, 12 months, 24 months, and 36 months after your treatment. Throughout this period, any new side effects related to your treatment will also be noted.
Potential risks and benefits
Locations (7)
- Clinique PasteurVerified postcodeToulouse, France· Recruiting
- Centre de cancérologie Les DentellièresVerified postcodeValenciennes, France· Recruiting
- University Hospitals of Derby & Burton NHS Foundation TrustVerified postcodeDerby, United Kingdom· Recruiting
- The Clatterbridge Cancer Centre NHS Foundation TrustVerified postcodeLiverpool, United Kingdom· Recruiting
- Royal Free LondonVerified postcodeLondon, United Kingdom· Not yet recruiting
- Maidstone & Tunbridge Wells NHS TrustVerified postcodeMaidstone, United Kingdom· Recruiting
- Norfolk & Norwich University Hospital NHS Foundation TrustVerified postcodeNorwich, United Kingdom· Recruiting
Common questions
What is the SpaceOAR hydrogel system?
It's a special gel doctors can put between your prostate and back passage (rectum) before radiotherapy for prostate cancer. It helps protect the rectum from radiation.
Will my treatment change if I join this study?
No, your prostate cancer treatment and how the hydrogel spacer is used will not change at all if you take part in this study.
What kind of information will you collect?
Researchers will look at your medical records and ask you to fill out questionnaires about your health, treatment, and any side effects you experience.
How long will the study follow me?
The study will collect information from you over about three years (36 months) after your treatment, at set times.
Can I stop participating if I change my mind?
Yes, you can decide to stop being part of the study at any time. It will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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