This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

The Prostate Immobilization Device Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Taylor, Wheaton Franciscan Healthcare
ClinicalTrials.gov Identifier:
NCT01408706
First received: July 25, 2011
Last updated: June 13, 2017
Last verified: June 2017
  Purpose
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 Intervention
Adenocarcinoma of the Prostate Device: Miller Air tip Device: Radiadyne Immobilizer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prostate Immobilization Device Study

Further study details as provided by James Taylor, Wheaton Franciscan Healthcare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 .


Enrollment: 60
Study Start Date: August 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408706

Locations
United States, Wisconsin
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
  More Information

Responsible Party: James Taylor, James Taylor, MD, Wheaton Franciscan Healthcare
ClinicalTrials.gov Identifier: NCT01408706     History of Changes
Other Study ID Numbers: 11-019-ASH
Study First Received: July 25, 2011
Results First Received: October 24, 2016
Last Updated: June 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 19, 2017