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Cone Beam CT for Daily Image Guidance - Prostate Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00188786
Collaborator
Princess Margaret Hospital, Canada (Other)
30
Enrollment
1
Location
60
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: daily Cone Beam CT for imaging guidance for radiotherapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Outcome Measures

Primary Outcome Measures

  1. 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

  1. To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia. []

  2. To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia. []

  3. To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto
  • Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Charles Catton, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00188786
Other Study ID Numbers:
  • UHN REB 05-0037-C
First Posted:
Sep 16, 2005
Last Update Posted:
Feb 15, 2011
Last Verified:
Feb 1, 2011
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Feb 15, 2011