OASIS: SpaceOAR Post-Market Registry Study
Research type
Research Study
Full title
OASIS: SpaceOAR Post-Market Registry Study: assessing the safety & acceptability of SpaceOAR use with prostate radiotherapy
IRAS ID
341038
Contact name
Derek J P Rosario
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
4 years, 4 months, 28 days
Research summary
Rectal spacers are gel-like implants placed between the prostate and rectum to temporarily shift the rectal wall away from the prostate during radiation therapy for prostate cancer. Made from a biodegradable material, these spacers naturally dissolve over time and do not require removal. By increasing the distance between the prostate and rectum, rectal spacers help protect healthy rectal tissue from radiation exposure, thereby reducing the risk of side effects and damage to surrounding healthy cells.
In the UK in February 2023, NICE, the body that provides guidance for health, concluded that there were uncertainties about how well rectal spacers work and how safe they are. Similar concerns were raised by the French National Authority for Health.
This study aims to provide independent information about the long-term safety of rectal spacers and if patients find them acceptable. This information will be shared with the health regulatory authorities to inform future decisions. We are specifically assessing the CE-marked SpaceOAR and SpaceOAR Vue systems as most of the information we already have is based on these rectal spacers.
Cancer treatment centres across the UK will participate in the study. Eligible participants will be patients who are due to receive a rectal spacer as part of their standard radiotherapy care for prostate cancer. This is an observational study and does not involve any experimental interventions, changes to treatment planning, or additional medical procedures.
Participation involves providing informed consent for the collection of safety data from medical records and completing quality of life questionnaires from the time of consent up to 36 months following spacer implantation.REC name
East of Scotland Research Ethics Service REC 1
REC reference
25/ES/0073
Date of REC Opinion
3 Sep 2025
REC opinion
Further Information Favourable Opinion