SpaceOAR Post-Market Registry for Rectal Hydrogel Spacers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Brest, Boulevard de Tanguy Prigent
  Brest, France Recruiting
• 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 Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.