SpaceOAR Post-Market Registry Study
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci zdiagnozowani z rakiem prostaty, którzy będą leczeni radioterapią z zastosowaniem żelu SpaceOAR.
- •Osoby w wieku 18 lat lub starsze.
- •Pacjenci wyrażający zgodę na udział w badaniu i posiadający zdolność do jej udzielenia.
- •Pacjenci objęci ubezpieczeniem społecznym (tylko we Francji).
✗ Disqualifies
- •Pacjenci, którzy nie mogą udzielić świadomej zgody na udział w badaniu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 30, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (8)
CHU de Brest, Boulevard de Tanguy Prigent
Brest, France
Clinique Pasteur
Toulouse, France
Centre de cancérologie Les Dentellières
Valenciennes, France
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Royal Free London
London, United Kingdom
Maidstone & Tunbridge Wells NHS Trust
Maidstone, United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom
Trial contact
Ulrike Pr SCHICK
Ulrike Schick
PRINCIPAL_INVESTIGATOR
Igor Latorzeff
Benjamin Vandendorpe
Prantik Das
Prantik Das
PRINCIPAL_INVESTIGATOR
Isabel Syndikus
Isabel Syndikus
PRINCIPAL_INVESTIGATOR
Amy Clifford
Amy Clifford
PRINCIPAL_INVESTIGATOR
Albert Edwards
Albert Edwards
PRINCIPAL_INVESTIGATOR
Jenny Nobes
Jenny Nobes
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.
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