Clinical trial · Interventional
Protection of Rectum From High Radiation Doses
NCT01601691CI-TRIAL-00016068completedN/AResults postedClinicalTrials.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 this study is to evaluate the usefulness of diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy.
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 |
|---|---|---|---|
| DuraSeal | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Spacer
- description
- Subjects with spacer injection
- interventionNames
- Device: DuraSeal
Primary outcomes (1)
- measure
- Spacer Volume Half Life
- timeFrame
- 1 day, 4 weeks, 8 weeks, up-to 16 weeks
- description
- Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.
Secondary outcomes (2)
- measure
- Side Effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 76 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 (1)
- DERIVEDHeikkila VP, Karna A, Vaarala MH. DuraSeal as a spacer to reduce rectal doses in low-dose rate brachytherapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):233-6. doi: 10.1016/j.radonc.2014.08.012. Epub 2014 Sep 4. PMID 25201125