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SpaceOAR Post-Market Registry Study

Recruitingn/aAges 18 Years - anyMaleSheffield Teaching Hospitals NHS Foundation Trust
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • SpaceOAR / SpaceOAR Vue hydrogel system
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Where

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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