The Prostate Immobilization Device Study

This study is currently recruiting participants.
Verified January 2014 by Wheaton Franciscan Healthcare
Sponsor:
Information provided by (Responsible Party):
James Taylor, Wheaton Franciscan Healthcare
ClinicalTrials.gov Identifier:
NCT01408706
First received: July 25, 2011
Last updated: January 22, 2014
Last verified: January 2014
  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: Prostate gland immobilization with rectal balloon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Prostate Immobilization Device Study

Resource links provided by NLM:


Further study details as provided by Wheaton Franciscan Healthcare:

Primary Outcome Measures:
  • Deviation of the prostate rectal interface from its position at time of simulation. [ Time Frame: Measurments will be taken for at least 5 points on a weekly basis during each course of treatment. Data will be presented for the duration of a course of radiation therapy, up to nine weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of utilization and patient tolerance of the device. [ Time Frame: Results will be measured at every treatment. Data will be presented for the duration of a course of radiation therapy, up to nine weeks. ] [ Designated as safety issue: No ]
  • Calculated dose of radiation to the rectum of the two immobilization devices will be measured and documented after the radiation treatment plan has been approved. [ Time Frame: Documented at each treatment. Data will be presented for the duration of a course of radiation therapy, up to nine weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Miller enema air tip
Use of Miller enema air tip to fix prostate location and displace rectal tissue during radiation therapy.
Device: 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.
Other Names:
  • Miller Enema Air Tip
  • Radiadyne Prostate Immobilizer Treatment Device
Active Comparator: Radiadyne Immobilizer Treatment Device
Use of Radiadyne Immobilizer Treatment Device to fix prostate location and displace rectal tissue during radiation therapy
Device: 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.
Other Names:
  • Miller Enema Air Tip
  • Radiadyne Prostate Immobilizer Treatment Device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408706

Contacts
Contact: Sandra Georgeson, RN, CCRP 262-687-5057 sandra.georgeson@wfhc.org

Locations
United States, Wisconsin
Wheaton Francsican Cancer Care - All Saints Recruiting
Racine, Wisconsin, United States, 53405
Contact: Sandra Georgeson, RN, CCRP    262-687-5057      
Sponsors and Collaborators
James Taylor
Investigators
Principal Investigator: James H Taylor, MD Wheaton Franciscan Cancer Care - All Saints
  More Information

No publications provided

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
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

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 April 23, 2014