SpaceOAR Post-Market Registry Study (OASIS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Patients Treated by Radiotherapy
• Intervention / Treatment: Device: SpaceOAR / SpaceOAR Vue hydrogel system

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31300
    • Recruiting
    • Clinique Pasteur
    • Contact: Igor Latorzeff; Phone Number: +33 5 62 21 31 31; Email: ilatorzeff@clinique-pasteur.com
  • Valenciennes, France, 59300
    • Recruiting
    • Centre de cancerologie Les Dentellieres
    • Contact: Benjamin Vandendorpe; Phone Number: +33 3 27 09 10 10; Email: bvandendorpe@lesdentellieres.com
• United Kingdom
  • Liverpool, United Kingdom, L7 8YA
    • Recruiting
    • The Clatterbridge Cancer Centre NHS Foundation Trust
    • Principal Investigator: Isabel Syndikus
    • Contact: Isabel Syndikus; Phone Number: 01513344000; Email: isabel.syndikus@nhs.net
  • London, United Kingdom, NW3 2QG
    • Not yet recruiting
    • Royal Free London
    • Contact: Amy Clifford
    • Principal Investigator: Amy Clifford
  • Maidstone, United Kingdom, ME16 9QQ
    • Recruiting
    • Maidstone & Tunbridge Wells NHS Trust
    • Principal Investigator: Albert Edwards
    • Contact: Albert Edwards; Phone Number: +1622729000; Email: albert.edwards@nhs.net
  • Norwich, United Kingdom, NR 7UY
    • Recruiting
    • Norfolk & Norwich University Hospital NHS Foundation Trust
    • Contact: Jenny Nobes; Phone Number: 4416603286286; Email: jenny.nobes@nnuh.nhs.uk
    • Principal Investigator: Jenny Nobes
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Recruiting
      • University Hospitals of Derby & Burton NHS Foundation Trust
      • Contact: Prantik Das; Phone Number: 01332 340131; Email: prantik.das3@nhs.net
      • Principal Investigator: Prantik Das

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; Participants receiving prostate cancer care in the UK and France	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with Grade 2* & above; gastrointestinal, anorectal, genitourinary toxicity at 12, 24 & 36 months.	Proportion of subjects experiencing Grade ≥2 toxicity (as per CTCAE v5.0) in gastrointestinal, anorectal, or genitourinary systems at 12, 24, and 36 months post-radiation therapy. • Unit of Measure: Percentage of subjects (%) Note: For French population, Grade ≥1 events will also be included.	12, 24, and 36 months post-radiation therapy
Physician rating of SpaceOAR/SpaceOAR Vue of Placement Difficulty	Rated on a Likert scale (1 = very difficult, 5 = very easy) immediately after procedure. Unit of Measure: Mean Likert score	At time of implantation
Patient Perception of SpaceOAR/SpaceOAR Vue Procedure Compared to Prostate Biopsy	Measured using a structured questionnaire comparing perceived discomfort and acceptability relative to prostate biopsy. • Unit of Measure: Percentage of subjects reporting "less discomfort," "similar," or "more discomfort	Within 30 days post-procedure
Overall Mortality and Cause of Death	Number and proportion of subjects who die during the study period, with cause adjudicated by Independent Clinical Events Committee. • Unit of Measure: Number of deaths and percentage (%)	Up to 36 months
Selection Criteria for SpaceOAR/SpaceOAR Vue Placement	Analysis of baseline clinical and demographic factors associated with successful placement. • Unit of Measure: Descriptive statistics (frequency, percentage)	At enrolment
Time to Onset of Grade ≥2 Gastrointestinal, Anorectal, and Genitourinary Toxicity	Measured as time (in months) from radiation therapy completion to first occurrence of Grade ≥2 toxicity (per CTCAE v5.0). • Unit of Measure: Median time to onset (months)	Up to 36 months
Impact of treatment on bowel function, urinary function, sexual function and overall quality of life as measured by EPIC-26	The EPIC-26 questionnaire is a preeminent tool extensively characterised to measure health-related quality of life in men with localised prostate cancer across specific domains; Urinary function; Bowel function; Sexual function; Effects of hormone treatment Scores range from 0-100, with higher scores indicating better function or quality of life. Unit of Measure: Mean score change from baseline (points)	Baseline, 12, 24 and 36 months
Impact of treatment on bowel function, urinary function, sexual function and overall quality of life as measured by IPSS	International Prostate Symptom Score (IPSS). IPSS assesses urinary voiding symptoms and bother. For voiding symptoms, a score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms, and the urinary bother scale ranges from 0 (Delighted) to 6 (Terrible). Unit of Measure: Mean score change from baseline (points)	Baseline, 12, 24 and 36 months
Impact of treatment on bowel function as measured by Vaizey incontinence score	The Vaizey Incontinence Score is a general-purpose scale for faecal incontinence that ranges from 0 to 24 with higher scores representing worst incontinence. Unit of Measure: Mean score change from baseline (points)	Baseline, 12, 24 and 36 months
Impact of concomitant prostate cancer treatment usually Androgen Deprivation Therapy (ADT) on the lives of participants as measured by The Symptom Index	The Symptom Index is an un-validated questionnaire which has been developed to capture the impact of the side effects of concomitant prostate cancer treatment (usually ADT} on the lives of participants. The questions capture the quality of life using the scale: 0 - 4, with higher scores indicating worse symptoms or quality of life. Unit of measure: Mean score change from baseline (points)	Baseline, 12, 24, 36 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: Sheffield Hallam University; Clinique Pasteur Toulouse
• Investigators: Study Chair: Derek Rosario, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: rectal spacer
• Other Study ID Numbers: STH22555; IRAS Project ID: 341038 (Other Identifier: HRA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes