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Cone Beam CT for Daily Image Guidance - Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00188786
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 15, 2011
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

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
Prostatic Neoplasms Procedure: daily Cone Beam CT for imaging guidance for radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2005
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188786

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Charles Catton, MD Princess Margaret Hospital, Canada

Responsible Party: Dr Charles Catton, Staff Radiation Oncologist, University Health Network, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00188786     History of Changes
Other Study ID Numbers: UHN REB 05-0037-C
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases