NCT01538628

SpaceOAR System Pivotal Study

Evaluation of SpaceOAR™ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

Detailed description

The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure to the anterior rectum.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	SpaceOAR System	Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-02-24
• Last updated: 2021-03-19
• Results posted: 2021-03-19

Locations

20 sites across 1 country: United States