Clinical trial · Interventional
Protection of Rectum From High Radiation Doses Using a Spacer
Protection of Rectum From High Radiation Doses During Prostate Cancer Low-dose Brachytherapy Using Diluted or Non-diluted DuraSeal as a Spacer
NCT01918605CI-TRIAL-00030085terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient enrollment.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the usefulness of diluted and non-diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasms, Male | — | UNRESOLVED | — |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Urogenital Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diluted spacer | Device | — | UNRESOLVED |
| Non-diluted spacer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diluted spacer
- description
- Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
- interventionNames
- Device: Diluted spacer
- type
- ACTIVE_COMPARATOR
- label
- Non-diluted spacer
- description
- Single dose of DuraSeal product injected between rectum and prostate
- interventionNames
- Device: Non-diluted spacer
Primary outcomes (1)
- measure
- Change in spacer volume
- timeFrame
- 1 day, 4 weeks, 8 weeks, 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * prostate cancer patients with planned low-dose brachytherapy for the treatment of prostate cancer Exclusion Criteria: * not willing to participate this study
References
Publications (0)
Data not yet available
No reference posted for this study.