The Prostate Immobilization Device Study

• Sponsor: James Taylor (Other)
• Overall Status: Completed
• CT.gov ID: NCT01408706
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Prostate	Device: Miller Air tip; Device: Radiadyne Immobilizer	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Prostate Immobilization Device Study
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 .

2. 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 .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wheaton Francsican Cancer Care - All Saints	Racine	Wisconsin	United States	53405

Sponsors and Collaborators

• James Taylor

Investigators

• Principal Investigator: James H Taylor, MD, Wheaton Franciscan Cancer Care - All Saints

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James Taylor, James Taylor, MD, Wheaton Franciscan Healthcare
• ClinicalTrials.gov Identifier: NCT01408706
• Other Study ID Numbers: 11-019-ASH
• First Posted: Aug 3, 2011
• Last Update Posted: Jun 29, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

Participant Flow

Arm/Group Title	Miller Enema Air Tip	Radiadyne Immobilizer Treatment Device
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	30	30
COMPLETED	29	30
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Miller Enema Air Tip	Radiadyne Immobilizer Treatment Device	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 23.3%	7 23.3%	14 23.3%
>=65 years	23 76.7%	23 76.7%	46 76.7%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	30 100%	30 100%	60 100%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%
Clinically localized T1-3, NO, MO adenocarcinoma of the prostate (participants) [Number]
Number [participants]	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Miller Enema Air Tip	Radiadyne Immobilizer Treatment Device
Arm/Group Description	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.	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.
Measure Participants	29	30
Mean (Standard Deviation) [CENTIMETERS]	.319 (.603)	.095 (.202)

2. Secondary Outcome

Title	Difficulty of Insertion.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Miller Enema Air Tip	Radiadyne Immobilizer Treatment Device
Arm/Group Description	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.	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.
Measure Participants	29	30
Mean (Full Range) [units on a scale]	1.083808	1.067535

3. Secondary Outcome

Title	Patient Expression of Discomfort
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Miller Enema Air Tip	Radiadyne Immobilizer Treatment Device
Arm/Group Description	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.	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
Measure Participants	29	30
Mean (Full Range) [units on a scale]	1.138237	1.087719

Adverse Events

Time Frame	up to nine weeks
Adverse Event Reporting Description	Investigator interviews patient weekly during treatment with exam as needed to assess for adverse events.
Arm/Group Title	Miller Enema Air Tip		Radiadyne Immobilizer Treatment Device
Arm/Group Description	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.		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.
All Cause Mortality
	Miller Enema Air Tip		Radiadyne Immobilizer Treatment Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Miller Enema Air Tip		Radiadyne Immobilizer Treatment Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Miller Enema Air Tip		Radiadyne Immobilizer Treatment Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.