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Cone Beam CT for Daily Image Guidance - Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
daily Cone Beam CT for imaging guidance for radiotherapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate Patient undergoing dose escalated conformal external beam radiation therapy Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score <8, Clinical T category <T3, Clinical N category 0 or X, M category 0 or X Age 18 years or older ECOG performance status 0 or 1 Informed consent Exclusion Criteria: Inflammatory bowel disease or collagen vascular disease

Sites / Locations

  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer.

Secondary Outcome Measures

To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia.
To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia.
To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models.

Full Information

First Posted
September 12, 2005
Last Updated
February 11, 2011
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00188786
Brief Title
Cone Beam CT for Daily Image Guidance - Prostate Cancer
Official Title
A Phase II Feasibility Study of Cone Beam Computed Tomography for Daily Image Guidance in Patients Receiving Dose Escalated Conformal Radiation Therapy for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

5. Study Description

Brief Summary
Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
daily Cone Beam CT for imaging guidance for radiotherapy
Primary Outcome Measure Information:
Title
To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer.
Secondary Outcome Measure Information:
Title
To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia.
Title
To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia.
Title
To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate Patient undergoing dose escalated conformal external beam radiation therapy Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score <8, Clinical T category <T3, Clinical N category 0 or X, M category 0 or X Age 18 years or older ECOG performance status 0 or 1 Informed consent Exclusion Criteria: Inflammatory bowel disease or collagen vascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Catton, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Cone Beam CT for Daily Image Guidance - Prostate Cancer

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