NCT05407714

SpaceOAR System RWS in China

Completed NA Results posted Last updated 27 October 2025

What this trial tests

NA trial testing SpaceOAR Treatment in Localized T1-T2 Prostate Cancer in 15 participants. Completed in 6 July 2023.

Timeline

18 August 2022

Primary endpoint
12 June 2023

6 July 2023

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	18 August 2022
Primary completion	12 June 2023
Estimated completion	6 July 2023
Sites	1 location across China

Drugs / interventions tested

• SpaceOAR Treatment

Conditions studied

• Localized T1-T2 Prostate Cancer — all drugs for Localized T1-T2 Prostate Cancer →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

Eligibility, any sex, with Localized T1-T2 Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Effectiveness Endpoint Primary · Within 10 days post spaceOAR hydrogel administration.

The distance between the posterior prostatic capsule and anterior rectal wall,

Group	Value	95% CI
SpaceOAR Treatment Arm	15.1	± 1.8

Primary Safety Endpoint Primary · Within 30 days following procedure

Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed.

Group	Value	95% CI
SpaceOAR Treatment Arm	2

Functional Success Secondary · Within 10 days post spaceOAR hydrogel administration.

Distance Posterior Prostatic Capsule and Anterior Rectal Wall

Group	Value	95% CI
SpaceOAR Treatment Arm	14

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days post procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SpaceOAR Treatment Arm

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (4 terms — click to expand)

Reaction	System	SpaceOAR Treatment Arm
Urinary hesitation	Renal and urinary disorders	—
Urinary retention	Renal and urinary disorders	—
Constipation	Gastrointestinal disorders	—
Influenza	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT05407714 adverse events section.

Sponsor's own description

This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.