SABRE; version D 21JAN2022
Research type
Research Study
Full title
Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body RadiothErapy SABRE
IRAS ID
312768
Contact name
Suneil Jain
Contact email
Sponsor organisation
Boston Scientific Corporation SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 6 months, 3 days
Research summary
This study would like to investigate the efficacy of the medical device SpaceOAR. The SpaceOAR Vue System is a hydrogel that positions the rectum away from the prostate which may help to minimize cancer radiation therapy side effects.
The prostate is next to the rectum and naturally separated by a small space called the perirectal space. The SpaceOAR Vue System hydrogel is placed with a needle in the space between the rectum and the prostate. Due to the closeness, prostate radiation therapy can unintentionally cause damage to the rectum, which can lead to issues with bowel function. By acting as a spacer, the hydrogel temporarily moves the rectum away from the prostate. By separating the rectum from the prostate, the SpaceOAR Vue System reduces the amount of radiation received by the rectum and may decrease damage to the rectum.
Patients will be placed in one of two groups by a computer program, approximately 333 subjects will receive the SpaceOAR Vue System hydrogel and will be considered part of the treatment group and approximately 167 will not receive the SpaceOAR Vue System hydrogel and will be considered part of the control group.
The treatment group as well as the control group may also receive fiducial markers to aid with the delivery of radiation therapy. The fiducial markers are placed at the discretion of the doctor. Stereotactic Body Radiotherapy (SBRT) will then be administered.
Data will be collected and recorded before, during and after the SBRT treatment.
Visits will occur 3, 6, 12, 18, 24, 36, 48, and 60 months after initiation of radiation therapy. Participation in the study will be completed after 5 years.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0079
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Favourable Opinion