At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)device
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.
Phase II Study of Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
University of Texas Southwestern Medical Center·interventional·Posted Feb 3, 2015·Updated Mar 25, 2022
In Brief
A Phase 2 clinical trial evaluating Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) for Prostate Cancer. Completed, enrolled 44 participants across 2 sites.
Detailed Summary
The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. It is also to determine whether it provides sufficient dosimetric benefits to warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation) related clinical studies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedFeb 2015
Primary CompletionJan 2018
Study CompletionJan 2021
TodayJul 2026
First PostedFeb 3, 2015
Enrollment StartNov 6, 2014
Primary CompletionJan 29, 2018
Study CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.4 years ago
Interventions
Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)device
Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product