The Prostate Immobilization Device Study

NCT01408706 | Completed Results

• 1 other identifier: 11-019-ASH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 9 weeks

Secondary Outcomes (2)

• Difficulty of Insertion.

  Up to nine weeks

• Patient Expression of Discomfort

  Up to nine weeks

Study Arms (2)

Miller enema air tip

ACTIVE COMPARATOR

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

Radiadyne Immobilizer

ACTIVE COMPARATOR

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

Interventions

Miller Air tip DEVICE

Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.

Also known as: Miller Enema Air Tip

Miller enema air tip

Radiadyne Immobilizer DEVICE

Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment

Radiadyne Immobilizer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate
• Planned definitive radiation therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• James Taylor: lead

Study Sites (1)

Wheaton Francsican Cancer Care - All Saints

Racine, Wisconsin, 53405, United States

Location

Results Point of Contact

• Title: Dr. James Taylor
• Organization: Wheaton Franciscan Healthcare - All Saints

james.taylor@wfhc.org

262-687-5000

Study Officials

• James H Taylor, MD

  Wheaton Franciscan Cancer Care - All Saints

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: James Taylor, MD

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: August 3, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)