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Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Abbott-CARO Uro-Oncologic Radiation Award
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188799
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Prostatic Neoplasms
 Procedure: daily Xray volume imaging for planning radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

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

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

Estimated Enrollment: 30
Study Start Date: November 2003
Estimated Study Completion Date: November 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188799

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Abbott-CARO Uro-Oncologic Radiation Award
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Charles Catton, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188799     History of Changes
Other Study ID Numbers: UHN REB 03-0483-CE, Abbott-CARO Uro-OncologicAward
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 16, 2013