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Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
daily Xray volume imaging for planning radiotherapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Hospital

Outcomes

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.

Full Information

First Posted
September 12, 2005
Last Updated
July 15, 2015
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada, Canadian Association of Radiation Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00188799
Brief Title
Xray Volume Imaging (Cone Beam CT) - Prostate Cancer
Official Title
A Clinical Study of X-ray Volume Imaging to Evaluate the Daily Set-up Accuracy of Conformal Prostate Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada, Canadian Association of Radiation Oncology

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
daily Xray volume imaging for planning radiotherapy
Primary Outcome Measure Information:
Title
To evaluate he feasibility of daily X-ray volume imaging during conformal radiotherapy.
Secondary Outcome Measure Information:
Title
To provide preliminary data concerning the relative utility of daily X-ray volume image matching compared to fiducial marker image matching.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Catton, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

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