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NCT02353832 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT02353832: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT02353832 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02353832, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study 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.
Primary Outcome
The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects
Interventions
- DEVICE Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-11-06 |
| Est. Completion | 2021-01-05 |
| Phase | Phase 2 |
What the finished NCT02353832 record still lists
NCT02353832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) is the first listed.
NCT02353832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02353832 about?
NCT02353832 is a clinical study titled "Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer". 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 clinic...
What is the current status of trial NCT02353832?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2014-11-06. Estimated completion is 2021-01-05.
What interventions are being tested in trial NCT02353832?
The interventions under investigation include: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) (DEVICE).
Who is sponsoring clinical trial NCT02353832?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02353832's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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