N/A
Completed N=60
The Prostate Immobilization Device Study
Source: ClinicalTrials.gov NCT01408706 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. — .319; .095 CENTIMETERS
Summary
The purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. |
.319; .095 | — |
| SECONDARY Difficulty of Insertion. |
1.083808; 1.067535 | — |
| SECONDARY Patient Expression of Discomfort |
1.138237; 1.087719 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate
- Planned definitive radiation therapy
Exclusion Criteria
- Prior proctectomy
- Rectal surgery within one year
- Proctitis
- Rectal carcinoma
- Anal Stenosis
- History of inflammatory bowel disease
- Scleroderma
- Systemic sclerosis
- Refusal of treatment with immobilization device
Data sourced from ClinicalTrials.gov (NCT01408706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.