OASIS: SpaceOAR post-market registry study

In recruitment.

The study expected to run until January 2030.

Funded by Boston Scientific Corporation.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust.

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.

Studies have shown these can lead to a reduced dose of radiation to the rectum and therefore reduce side effects from radiation. These spacers have been used in cancer treatment centres in the UK, as well as Europe and other countries, for over 6 years.

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.

Full information on patient recruitment is available on the UK Clinical Study Registry.

To document the safety, acceptability and long-term outcomes of SpaceOAR and SpaceOAR Vue hydrogel rectal spacers in subjects undergoing radiation therapy (External Beam Radiotherapy or brachytherapy) to treat prostate cancer.

This observational multi-centre, multi-national study uses a prospective cohort design. This design was chosen because the study is intended to act as an enhanced form of post-marketing surveillance for the SpaceOAR rectal spacer system with the primary purpose of assessing the safety of the system in usual care. This device is currently under a NICE special arrangements recommendation and collection of further safety data is warranted.

Pending.

Dr Grace Price: grace.price@shu.ac.uk

Dr Saïd Ibeggazene: s.Ibeggazene@shu.ac.uk.