Tracking the safety of a rectal hydrogel spacer used with prostate cancer radiotherapy
Collects safety and side-effect information from men receiving a spacer during prostate radiotherapy.
Key facts
- Who runs it
- Sheffield Teaching Hospitals NHS Foundation Trust
- Where
- Brest, Toulouse, and Valenciennes, FranceSee the 3 sitesAlso in 1 other country, 5 sites
- Trial code
- Registry title
- SpaceOAR Post-Market Registry Study
- Status
- Recruiting
- People taking part
- 320 people, planned
- Started
- 31 Dec 2025
- Expected to end
- Feb 2030
- Type of study
- Observational
- Treatments tested
- SpaceOAR / SpaceOAR Vue hydrogel system
- Record updated
- 30 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer who will have radiotherapy treatment meant to remove all of the disease, and who are getting a SpaceOAR rectal hydrogel spacer as part of usual care at selected sites in the UK and France.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer diagnosed by a doctor, with radiotherapy planned to remove all of the disease.
- Earlier treatment
- A SpaceOAR spacer is planned as part of usual care.
Main reasons for not taking part
- Patients who cannot give informed consent (verbal consent by phone in the UK, written consent in France)
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- All patients with a clinical diagnosis of prostate cancer planned to undergo treatment with curative intent at selected sites in the UK \& France subject to a SpaceOAR being used as usual care
- 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, informed consent over telephone as documented on the study informed consent form by the Researchers (UK only); written, informed consent by signature of the study informed consent form (France only)
- Patient covered by social security scheme (France only)
Who cannot take part
- Patients lacking the capacity to provide
- informed consent as documented on the study informed consent form by the - Researchers (UK only)
- written, informed consent by signature of the study informed consent form (France only)
Where in France
Also in 1 other country, 5 sites
- CHU de Brest, Boulevard de Tanguy PrigentBrest, FranceContact: Ulrike Pr SCHICKTaking people
- Clinique PasteurToulouse, FranceContact: Igor LatorzeffTaking people
- Centre de cancerologie les DentellieresValenciennes, FranceContact: Benjamin VandendorpeTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- All participants
Participants receiving prostate cancer care in the UK and France
Treatment: SpaceOAR / SpaceOAR Vue hydrogel system
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- OASIS: SpaceOAR PoSt - Market Registry Study: Assessing the Safety & Acceptability of SpaceOAR Use With Prostate Radiotherapy
- Plain-language title
- Tracking the safety of a rectal hydrogel spacer used with prostate cancer radiotherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 July 2026