Clinical trial · Interventional
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study
- 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)
This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer. Study visits: * Screening * Spacer placement * Treatment planning simulation * End of the radiation treatment * 1, 3, 6, 12, 18 and 24-months FU visits.
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 |
|---|---|---|---|
| BioProtect Balloon Implant™ System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BioProtect Balloon Implant System
- description
- The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone
- interventionNames
- Device: BioProtect Balloon Implant™ System
Primary outcomes (1)
- measure
- Dosimetry
- timeFrame
- 6 months
- description
- Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with prostate cancer ≥ 18 years of age. 2. Patients are in one of the following risk groups: * T1-T3 prostate cancer with no posterior extra capsular extension * Gleason score ≤ 7 3. Planned for radiation treatment with rectal spacer. 4. Ability to understand and the willingness to sign a written informed consent form. Exclusion Criteria: 1. Metastatic disease. 2. Previously treated localized adenocarcinoma of the prostate. 3. Active Inflammatory bowel disease requiring treatment with steroids. 4. Prior total prostatectomy. 5. Current urinary tract infection. 6. Acute or chronic prostatitis.
References
Publications (0)
Data not yet available