The Prostate Immobilization Device Study
|ClinicalTrials.gov Identifier: NCT01408706|
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
|Condition or disease||Intervention/treatment|
|Adenocarcinoma of the Prostate||Device: Miller Air tip Device: Radiadyne Immobilizer|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Prostate Immobilization Device Study|
|Study Start Date :||August 2011|
|Primary Completion Date :||October 2014|
|Study Completion Date :||October 2014|
Active Comparator: Miller enema air tip
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
Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.
Other Name: Miller Enema Air Tip
Active Comparator: Radiadyne Immobilizer
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
Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment
- Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. [ Time Frame: Up to 9 weeks ]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.
- Difficulty of Insertion. [ Time Frame: Up to nine weeks ]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 .
- Patient Expression of Discomfort [ Time Frame: Up to nine weeks ]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 .
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408706
|United States, Wisconsin|
|Wheaton Francsican Cancer Care - All Saints|
|Racine, Wisconsin, United States, 53405|
|Principal Investigator:||James H Taylor, MD||Wheaton Franciscan Cancer Care - All Saints|