Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188799
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 16, 2015
Princess Margaret Hospital, Canada
Canadian Association of Radiation Oncology
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH for intermediate risk patients with localised disease in 1997. This technique provides a much smaller margin of error for treatment set-up and delivery than with conventional techniques. One way to ensure the accuracy of treatment delivery is to image the prostate position daily, prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are implanted into the prostate under guided ultrasound (a standard procedure at PMH). However, there are disadvantages in using imaging markers which include added time to the treatment planning process, and an invasive procedure with a potential for discomfort, bleeding and infection. This study will investigate and compare X-ray volume imaging to the gold standard imaging markers.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: daily Xray volume imaging for planning radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of X-ray Volume Imaging to Evaluate the Daily Set-up Accuracy of Conformal Prostate Radiotherapy
Study Start Date : November 2003
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Primary Outcome Measures :
  1. To evaluate he feasibility of daily X-ray volume imaging during conformal radiotherapy.

Secondary Outcome Measures :
  1. To provide preliminary data concerning the relative utility of daily X-ray volume image matching compared to fiducial marker image matching.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the prostate
  • Patient undergoing escalated dose conformal external beam radiotherapy.
  • Patient has low or intermediate risk prognostic factors: all of PSA <21, Gleason score <8, clinical T category <T3, clinical N category 0 or X, M category 0 or X.
  • Informed consent

Exclusion Criteria:

  • No diagnosis of adenocarcinoma of the prostate
  • Patient not undergoing escalated dose conformal radiotherapy
  • Patient does not have low or intermediate risk prognostic factors

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 identifier (NCT number): NCT00188799

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

Responsible Party: University Health Network, Toronto Identifier: NCT00188799     History of Changes
Other Study ID Numbers: UHN REB 03-0483-CE
Abbott-CARO Uro-OncologicAward
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

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