Clinical trial · Interventional
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding
A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device
NCT00114985CI-TRIAL-00066135completedPhase 2ClinicalTrials.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)
During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.
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 |
|---|---|---|---|
| Prostate Immobilization Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rectal toxicity at six month intervals
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Quality of Life
- timeFrame
- 2 years
- measure
- urinary symptoms
- timeFrame
- 2 years
- measure
- sexual dysfunction at six month intervals
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 31 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven prostate cancer * Clinical Stage T1 - T4 * Negative bone scan * PSA and routine blood work * \>30 years of age * ECOG Performance 0,1, or 2 * No prior pelvic radiation * No pacemaker Exclusion Criteria: * Inflammatory bowel disease (Crohns, or Ulcerative Colitis) * Prostatic rectal fistula * Stricture of anal canal
References
Publications (1)
- BACKGROUNDWoel R, Beard C, Chen MH, Hurwitz M, Loffredo M, McMahon E, Ching J, Lopes L, D'Amico AV. Acute gastrointestinal, genitourinary, and dermatological toxicity during dose-escalated 3D-conformal radiation therapy (3DCRT) using an intrarectal balloon for prostate gland localization and immobilization. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):392-6. doi: 10.1016/j.ijrobp.2004.10.003. PMID 15890580