At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SpaceOAR / SpaceOAR Vue hydrogel system (device)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- SpaceOAR / SpaceOAR Vue hydrogel system — device: Space OAR/SpaceOAR Vue Systems are biodegradable medical devices that are implanted between the prostate and rectum to temporarily move part of the rectal wall away from the prostate during radiation therapy for prostate cancer.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study collects information from prostate cancer patients in the UK and France who are having radiotherapy (a cancer treatment using radiation) as part of their usual care, where a product called SpaceOAR is being used. The study is run by Sheffield Teaching Hospitals NHS Foundation Trust. It aims to gather routine information rather than test a new treatment.
Who can take part
- Adults aged 18 or over
- People with a diagnosis of prostate cancer who are due to have treatment aiming to cure the cancer, at selected hospitals in the UK and France, where SpaceOAR is used as part of usual care
- Patients who agree to take part and, in their medical team's view, can give informed consent — verbally over the phone in the UK, or in writing in France
- Patients covered by a social security scheme (France only)
Who may not be able to
- People who cannot give informed consent — verbally over the phone in the UK, or in writing in France
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 320
- Started
- 2025-12-31
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer patients treated by radiotherapy
- • Clinical study - 320 participants
- • Recently, concerns have been raised by regulators that there is little data about the long-term safety of rectal hydrogel spacers for use in conjunction with radiotherapy treatment for prostate cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer patients treated by radiotherapy
- • Male only
Where?
- • Derby - University Hospitals of Derby & Burton NHS Foundation Trust
- • Liverpool - The Clatterbridge Cancer Centre NHS Foundation Trust
- • London - Royal Free London
- • Maidstone - Maidstone & Tunbridge Wells NHS Trust
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Recently, concerns have been raised by regulators that there is little data about the long-term safety of rectal hydrogel spacers for use in conjunction with radiotherapy treatment for prostate cancer. To address this, this study will collect data about the short-term side-effects and long-term safety of SpaceOAR and SpaceOAR Vue rectal hydrogel spacers in men who receive them in the UK and France. Men who have agreed to receive these spacers as part of their standard medical care will be asked to take part in the study whereby data about their treatment and health will be collected from their medical records and from members of the clinical team who deliver their treatment. Additionally, men will be asked to consent to completing questionnaires about their experiences of side effects from their treatment. Further information will be collected about their clinical characteristics before they receive a spacer, the physician-rated clinical performance of the spacer insertion procedure, their radiotherapy treatment plan and details of the other treatments they are also receiving which could influence the types and extent of side effects they experience. Data collection will span eight time points: pre-spacer insertion, spacer insertion, the start of radiotherapy, post-radiotherapy follow-up, 6-month follow-up, 12-month follow-up, 24-month follow-up \& 36-month follow-ups. Outside of these timepoints treatment-related adverse event data will be concurrently reported and collated. Participants' treatments will not be changed as a result of their participation in this study. Data from this study will be used to summarise the characteristics of this study population, physicians' perceptions of the spacer implantation procedure, the radiotherapy treatments plans made, and the types, extent and timing of treatment-related adverse events and side effects.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
What the study is looking for
- ✓All patients with a clinical diagnosis of prostate cancer planned to undergo treatment with curative intent at...
- ✓Aged 18 years old or above.
- ✓Patients who agrees to participate and has been deemed by their medical team to have capacity to provide;
- ✓verbal, agreement to take part over telephone as documented on the study agreement to take part form by the Researchers (UK only)
- ✓written, agreement to take part by signature of the study agreement to take part form (France only)
Who cannot take part
- ✗\- Patients lacking the capacity to provide;
- ✗agreement to take part as documented on the study agreement to take part form by the - Researchers (UK only)
- ✗written, agreement to take part by signature of the study agreement to take part form (France only)
See the full criteria
Where Is This Study? (5 UK sites)
University Hospitals of Derby & Burton NHS Foundation Trust
Derby DE22 3NE, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool L7 8YA, United Kingdom
Royal Free London
London NW3 2QG, United Kingdom
Maidstone & Tunbridge Wells NHS Trust
Maidstone ME16 9QQ, United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust
Norwich NR 7UY, United Kingdom