SpaceOAR Post-Market Registry Study

NCT07300631 | Recruiting DMC FDA Device

• 2 other identifiers: STH22555IRAS Project ID: 341038
• Study Type: observational
• Target: 320
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Keywords

rectal spacer

Outcome Measures

Primary Outcomes (2)

• Short-term safety of SpaceOAR/SpaceOAR Vue systems.

  Proportion of subjects experiencing any of the following within 30 days post-implantation of SpaceOAR/SpaceOAR Vue hydrogel, as adjudicated by the Independent Clinical Events Committee: * Symptoms (PROMs): Measured using validated patient-reported outcome questionnaires. A subject is counted if any PROM score exceeds the predefined threshold for clinically significant symptoms. * Adverse Events (CTCAE v5.0): Measured as the occurrence of any adverse event graded per CTCAE v5.0. * Abnormal Imaging (MRI/CT): A subject is counted if any abnormality is confirmed by radiology review. \* The study instruments in the French population with include Grade 1 and above events (CTCAEv5.0) * Unit of Measure: Percentage of subjects (%) * Each category will be reported separately.

  30 days post-implantation

• Long-Term Safety of SpaceOAR/SpaceOAR Vue Systems

  Proportion of subjects experiencing Grade ≥2 gastrointestinal or anorectal toxicity (per CTCAE v5.0) within 3 years after completion of radiation therapy. \* The study instruments in the French population with include Grade 1 and above events (CTCAEv5.0) • Unit of Measure: Percentage of subjects (%)

  Up to 3 years post-radiation therapy

Secondary Outcomes (10)

• Proportion of subjects with Grade 2* & above; gastrointestinal, anorectal, genitourinary toxicity at 12, 24 & 36 months.

  12, 24, and 36 months post-radiation therapy

• Physician rating of SpaceOAR/SpaceOAR Vue of Placement Difficulty

  At time of implantation

• Patient Perception of SpaceOAR/SpaceOAR Vue Procedure Compared to Prostate Biopsy

  Within 30 days post-procedure

• Overall Mortality and Cause of Death

  Up to 36 months

• Selection Criteria for SpaceOAR/SpaceOAR Vue Placement

  At enrolment

Study Arms (1)

All participants

Participants receiving prostate cancer care in the UK and France

Device: SpaceOAR / SpaceOAR Vue hydrogel system

Interventions

SpaceOAR / SpaceOAR Vue hydrogel system 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.

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer having radiotherapy with curative intent and having a SpaceOAR as part of standard care.

You may qualify if:

• 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)

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Clinique Pasteur Toulouse: collaborator
• Sheffield Hallam University: collaborator

Study Sites (8)

CHU de Brest

Brest, 29200, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, 31300, France

RECRUITING

Centre de cancérologie Les Dentellières

Valenciennes, 59300, France

NOT YET RECRUITING

Chesterfield Royal Hospital

Chesterfield, S44 5BL, United Kingdom

NOT YET RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L7 8YA, United Kingdom

RECRUITING

Royal Free London

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

Maidstone & Tunbridge Wells NHS Trust

Maidstone, ME16 9QQ, United Kingdom

RECRUITING

Norfolk & Norwich University Hospital NHS Foundation Trust

Norwich, NR 7UY, United Kingdom

RECRUITING

Study Officials

• Derek Rosario

  Sheffield Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 24, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); FR (3)