The Prostate Immobilization Device Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigator assessed the device position and location of the interface between rectum and prostate weekly during the course of treatment. This information was obtained using a conebeam CT scan on the treatment couch prior to a regularly scheduled radiation treatment. The conebeam CT scan is a standard tool for monitoring patient position and radiation treatment accuracy. Prior to each radiation treatment, the patient was placed in a vaclock immobilization device, then aligned with room lasers to skin tattoos. On board portal imaging was then employed using the KvKv match technique to place isocenter as simulated. For intact prostate treatment, alignment was made to implanted gold fiducial markers. For post prostatectomy patients, the alignment was to pelvic bony anatomy. After patient alignment was complete, a conebeam CT scan was obtained. The position of the anterior rectal wall and the interface between prostate and rectum was compared to the position of these structures at the time of simulation. Measurement was taken in the midline of the prostate gland between its base and apex of the maximum deviation of the rectum prostate interface from its position at the time of simulation. For post prostatectomy patients, a measurement was taken of the maximum deviation from simulation of interface between the rectum and the prostate bed/bladder. These measurements were recorded weekly by the treating radiation oncologist on the Physician Data Sheet. The difficulty of device insertion, positioning and inflation was recorded daily by the treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(unable to insert). These results were summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary. Patient expression of discomfort during device placement was recorded daily by treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(intolerable). These responses will be summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.

Official Title
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The Prostate Immobilization Device Study

Conditions
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Adenocarcinoma of the Prostate

Intervention / Treatment
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* Device: Miller Air tip
* Device: Radiadyne Immobilizer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Miller enema air tip<br>The Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy. | Device: Miller Air tip<br>* Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.<br>* Other names: Miller Enema Air Tip;|
| Active Comparator: Radiadyne Immobilizer<br>The Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy | Device: Radiadyne Immobilizer<br>* Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. | Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment. An average value will be determined for each patient. An average of individual patient values will be determined for each immobilization device. | Up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty of Insertion. | Difficulty of device insertion was scored for each treatment by the treating radiation therapist on a scale from 1(easiest) to 5(most difficult). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient . | Up to nine weeks | 
| Patient Expression of Discomfort | Patient expression of discomfort was scored for each insertion by the treating radiation therapist on a scale from 1(none) to 5(intolerable). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient . | Up to nine weeks |