NCT07300631: OASIS

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

Recruiting now Last updated 6 May 2026

What this trial tests

trial testing SpaceOAR / SpaceOAR Vue hydrogel system in Prostate Cancer Patients Treated by Radiotherapy in 320 participants. Currently enrolling.

Timeline

31 December 2025

Primary endpoint
1 February 2030

1 February 2030

Quick facts

Lead sponsor	Sheffield Teaching Hospitals NHS Foundation Trust
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	320
Start date	31 December 2025
Primary completion	1 February 2030
Estimated completion	1 February 2030
Sites	7 locations across France, United Kingdom

Drugs / interventions tested

• SpaceOAR / SpaceOAR Vue hydrogel system

Conditions studied

• Prostate Cancer Patients Treated by Radiotherapy — all drugs for Prostate Cancer Patients Treated by Radiotherapy →

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Who can join

18 and older, male only, with Prostate Cancer Patients Treated by Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Short-term safety of SpaceOAR/SpaceOAR Vue systems.
  Time frame: 30 days post-implantation
  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 (
• Long-Term Safety of SpaceOAR/SpaceOAR Vue Systems
  Time frame: Up to 3 years post-radiation therapy
  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 (%)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.