The Prostate Immobilization Device Study

Adenocarcinoma of the Prostate Clinical Trial

Official title:

The Prostate Immobilization Device Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408706
• Other study ID #: 11-019-ASH
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: April 13, 2015
• Start date: August 2011
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Wheaton Franciscan Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Wheaton Francsican Cancer Care - All Saints	Racine	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
James Taylor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deviation of the prostate rectal interface from its position at time of simulation.		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.	No
Secondary	Ease of utilization and patient tolerance of the device.		Results will be measured at every treatment. Data will be presented for the duration of a course of radiation therapy, up to nine weeks.	No
Secondary	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.		Documented at each treatment. Data will be presented for the duration of a course of radiation therapy, up to nine weeks.	No