SpaceOAR Post-Market Registry for Rectal Hydrogel Spacers

OASIS: SpaceOAR PoSt - Market Registry Study: Assessing the Safety & Acceptability of SpaceOAR Use With Prostate Radiotherapy

This project will see how safe SpaceOAR and SpaceOAR Vue rectal hydrogel spacers are by collecting short- and long-term side-effect information from men receiving radiotherapy for prostate cancer in the UK and France.

Quick facts

• Study type: Observational
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (Academic / other)
• Locations: 7 sites (Toulouse and 6 other locations)
• Trial ID: NCT07300631 on ClinicalTrials.gov

What this trial studies

This observational post-market registry will collect clinical and safety data from men who receive SpaceOAR or SpaceOAR Vue as part of routine radiotherapy care at participating centres in the UK and France. Data will be obtained from medical records and treating clinicians, and participants will be asked to complete questionnaires about side effects and their experiences. The registry will capture baseline clinical characteristics, physician-rated performance of the spacer insertion procedure, short-term complications, and long-term safety outcomes. No additional interventions are required beyond usual care and enrollment follows local consent procedures.

Who should consider this trial

Good fit: Ideal candidates are men with prostate cancer planned for curative-intent radiotherapy who are receiving a SpaceOAR or SpaceOAR Vue spacer as part of routine care, are 18 or older, and can give informed consent under local procedures.

Not a fit: Men who do not receive a SpaceOAR spacer, are treated outside participating centres, or lack capacity to consent are not eligible and would not benefit from this registry's data collection.

Why it matters

Potential benefit: If successful, the registry could clarify long-term safety and side-effect risks of SpaceOAR devices and help patients and clinicians make better-informed treatment decisions.

How similar studies have performed: Randomized and observational studies have shown hydrogel spacers can reduce rectal radiation dose and short-term rectal toxicity, but long-term safety data remain limited, prompting this post-market follow-up.

Eligibility criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

\- 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 this trial is running

Toulouse and 6 other locations

• Clinique Pasteur — Toulouse, France (Recruiting)
• Centre de cancérologie Les Dentellières — Valenciennes, France (Recruiting)
• University Hospitals of Derby & Burton NHS Foundation Trust — Derby, Derbyshire, United Kingdom (Recruiting)
• The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, United Kingdom (Recruiting)
• Royal Free London — London, United Kingdom (Not_yet_recruiting)
• Maidstone & Tunbridge Wells NHS Trust — Maidstone, United Kingdom (Recruiting)
• Norfolk & Norwich University Hospital NHS Foundation Trust — Norwich, United Kingdom (Recruiting)

Conditions Prostate Cancer Patients Treated by Radiotherapy; rectal spacer