Trial Outcomes & Findings for The Prostate Immobilization Device Study (NCT NCT01408706)
NCT ID: NCT01408706
Last Updated: 2017-06-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Up to 9 weeks
Results posted on
2017-06-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
The Prostate Immobilization Device Study
Baseline characteristics by cohort
| Measure |
Miller Enema Air Tip
n=30 Participants
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.
|
Radiadyne Immobilizer Treatment Device
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Clinically localized T1-3, NO, MO adenocarcinoma of the prostate
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 9 weeksMeasurements 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.
Outcome measures
| Measure |
Miller Enema Air Tip
n=29 Participants
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.
|
Radiadyne Immobilizer Treatment Device
n=30 Participants
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.
|
|---|---|---|
|
Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.
|
.319 CENTIMETERS
Standard Deviation .603
|
.095 CENTIMETERS
Standard Deviation .202
|
SECONDARY outcome
Timeframe: Up to nine weeksDifficulty 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 .
Outcome measures
| Measure |
Miller Enema Air Tip
n=29 Participants
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.
|
Radiadyne Immobilizer Treatment Device
n=30 Participants
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.
|
|---|---|---|
|
Difficulty of Insertion.
|
1.083808 units on a scale
Interval 1.0 to 5.0
|
1.067535 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to nine weeksPatient 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 .
Outcome measures
| Measure |
Miller Enema Air Tip
n=29 Participants
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.
|
Radiadyne Immobilizer Treatment Device
n=30 Participants
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.
|
|---|---|---|
|
Patient Expression of Discomfort
|
1.138237 units on a scale
Interval 1.0 to 3.0
|
1.087719 units on a scale
Interval 1.0 to 3.0
|
Adverse Events
Miller Enema Air Tip
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Radiadyne Immobilizer Treatment Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Taylor
Wheaton Franciscan Healthcare - All Saints
Phone: 262-687-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place