NCT04905069: SABRE

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

Active, enrolled NA Last updated 11 May 2026

What this trial tests

NA trial testing SpaceOAR Vue System in Prostate Cancer in 500 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 December 2021

Primary endpoint
1 April 2027

1 April 2030

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	500
Start date	21 December 2021
Primary completion	1 April 2027
Estimated completion	1 April 2030
Sites	30 locations across United States, Australia, France, Germany, Ireland, Italy, Spain, Switzerland

Drugs / interventions tested

• SpaceOAR Vue System

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. 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.

• Late Gastrointestinal (GI) Toxicity
  Time frame: 3 to 24 months post-SBRT initiation
  Proportion of subjects experiencing late GI toxicity after SBRT treatment with or without placement of the SpaceOAR Vue System hydrogel. Late GI toxicity is defined as the occurrence of a Grade 2 or greater GI adverse event (NCI CTCAE v4) between 3- and 24-months post-SBRT initiation

Sponsor's own description

To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comprehensive review of the use of hydrogel spacers prior to radiation therapy for prostate cancer.
   Harvey M, Ong WL, Chao M, Udovicich C, et al · · 2023 · cited 23× · PMID 35689413 · DOI 10.1111/bju.15821
2. Hydrogel Spacer Insertion Prior to Stereotactic Body Radiation Therapy to the Prostate: A Comparative Study.
   Lutsyk M, Landman Y, Fenig E. · · 2026 · PMID 41536342 · DOI 10.1016/j.adro.2025.101966