Clinical trial · Interventional
Rectal Spacer for Prostate Cancer Radiation Image Guidance
Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance
NCT05650021CI-TRIAL-00098661completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine if a radiopaque hydrogel rectal spacer, SpaceOAR Vue®, can be used in place of fiducial markers when aligning patients for radiotherapy. The investigator hypothesizes that the alignment of the patient based on the rectal spacer will be similar to the alignment of the patient with fiducial markers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SpaceOAR Vue | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- SpaceOAR Vue and fiducial marker
- description
- After enrollment, patients will be treated per the standard of care, including the use of daily CBCT for image guided radiotherapy. The investigator will review the CBCT on the first day of treatment and align in such a way that the fiducials match up but also that the radio-opaque SpaceOAR lines up to within 5mm. If the SpaceOAR does not line up to within 5mm, the investigator will consider an intervention such as having the patient get off the table to pass gas, have a bowel movement, additional counseling about diet and bowel movement habits, or potentially even re-simulation. These daily CBCT images are aligned to the CT simulation images by way of aligning the fiducial markers on the respective imaging data sets. The CBCT images acquired during their first five fractions of radiotherapy will be imported into MIM software.
- interventionNames
- Device: SpaceOAR Vue
Primary outcomes (1)
- measure
- Cone beam CT alignment
- timeFrame
- 8 weeks
- description
- The radiation oncologist will measure the difference in anterior/posterior, superior/inferior, and lateral shifts between the cone beam CT alignment completed with fiducial markers and the cone beam CT alignment completed with the radiopaque hydrogel rectal spacer.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * To be eligible for the study, you must have already had SpaceOAR and fiducial markers placed before undergoing prostate radiotherapy, or you should have a plan to have them placed. * Untreated cT1 - cT3 prostate cancer Exclusion Criteria: * Extracapsular extension of prostate cancer * Prior prostatectomy
References
Publications (0)
Data not yet available
No reference posted for this study.