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Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00188799
Collaborator
Princess Margaret Hospital, Canada (Other), Canadian Association of Radiation Oncology (Industry)
30
Enrollment
1
Location
12
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: daily Xray volume imaging for planning radiotherapy
 Phase 2

Study Design

Study Type:
Interventional
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 :
Nov 1, 2003
Study Completion Date :
Nov 1, 2004

Outcome Measures

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. []

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 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

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
  • Canadian Association of Radiation Oncology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188799
Other Study ID Numbers:
  • UHN REB 03-0483-CE
  • Abbott-CARO Uro-OncologicAward
First Posted:
Sep 16, 2005
Last Update Posted:
Jul 16, 2015
Last Verified:
Jul 1, 2015
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 16, 2015