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SpaceOAR Post-Market Registry Study

NCT ID: NCT07300631

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2030-02-28

Brief Summary

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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 they receive a spacer, the physician-rated clinical performance of the spacer insertion procedure, their radiotherapy treatment plan and details of the other treatments they are also receiving which could influence the types and extent of side effects they experience. Data collection will span eight time points: pre-spacer insertion, spacer insertion, the start of radiotherapy, post-radiotherapy follow-up, 6-month follow-up, 12-month follow-up, 24-month follow-up \& 36-month follow-ups. Outside of these timepoints treatment-related adverse event data will be concurrently reported and collated. Participants' treatments will not be changed as a result of their participation in this study. Data from this study will be used to summarise the characteristics of this study population, physicians' perceptions of the spacer implantation procedure, the radiotherapy treatments plans made, and the types, extent and timing of treatment-related adverse events and side effects.

Detailed Description

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Conditions

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Prostate Cancer Patients Treated by Radiotherapy

Keywords

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rectal spacer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Participants receiving prostate cancer care in the UK and France

SpaceOAR / SpaceOAR Vue hydrogel system

Intervention Type DEVICE

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.

Interventions

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SpaceOAR / SpaceOAR Vue hydrogel system

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Pasteur Toulouse

OTHER

Sponsor Role collaborator

Sheffield Hallam University

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Derek Rosario

Role: STUDY_CHAIR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Chesterfield Royal Hospital

Chesterfield, , United Kingdom

Site Status NOT_YET_RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Free Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Maidstone & Tunbridge Wells NHS Trust

Maidstone, , United Kingdom

Site Status NOT_YET_RECRUITING

Norfolk & Norwich University Hospital NHS Foundation Trust

Norwich, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Omar Din

Role: primary

Isabel Syndikus

Role: primary

Amy Clifford

Role: primary

Albert Edwards

Role: primary

Jenny Nobes

Role: primary

Other Identifiers

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IRAS Project ID: 341038

Identifier Type: OTHER

Identifier Source: secondary_id

STH22555

Identifier Type: -

Identifier Source: org_study_id