At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 222 enrolled
Drug / intervention
SpaceOAR Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SpaceOAR System for Prostate Cancer. Completed, enrolled 222 participants across 20 sites.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsAugmenix, Inc.
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedFeb 2012
Primary CompletionJul 2014
TodayJul 2026
First PostedFeb 24, 2012
Enrollment StartJan 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.4 years ago
Interventions
SpaceOAR Systemdevice
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.