Adenocarcinoma of the Prostate
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEMiller Air tip
Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.
DEVICERadiadyne Immobilizer
Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment
Sponsors
James Taylor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulty of Insertion. | 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 | 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 . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Miller Enema Air Tip Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy. | 30 |
| Radiadyne Immobilizer Treatment Device Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy
Prostate gland immobilization with rectal balloon: Device: Prostate gland immobilization with rectal balloon (Miller enema air tip or Radiadyne Prostate Immobilizer Treatment Device) to fix prostate location and displace rectal tissue during radiation therapy. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Miller Enema Air Tip | Radiadyne Immobilizer Treatment Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 23 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Clinically localized T1-3, NO, MO adenocarcinoma of the prostate | 30 participants | 30 participants | 60 participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Up to 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Miller Enema Air Tip | Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. | .319 CENTIMETERS | Standard Deviation 0.603 |
| Radiadyne Immobilizer Treatment Device | Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation. | .095 CENTIMETERS | Standard Deviation 0.202 |
Secondary
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 .
Time frame: Up to nine weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Miller Enema Air Tip | Difficulty of Insertion. | 1.083808 units on a scale |
| Radiadyne Immobilizer Treatment Device | Difficulty of Insertion. | 1.067535 units on a scale |
Secondary
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 .
Time frame: Up to nine weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Miller Enema Air Tip | Patient Expression of Discomfort | 1.138237 units on a scale |
| Radiadyne Immobilizer Treatment Device | Patient Expression of Discomfort | 1.087719 units on a scale |