Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

A Clinical Study of X-ray Volume Imaging to Evaluate the Daily Set-up Accuracy of Conformal Prostate Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188799
• Other study ID #: UHN REB 03-0483-CE
• Secondary ID: Abbott-CARO Uro-
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 15, 2015
• Start date: November 2003
• Est. completion date: November 2004

Study information

• Verified date: July 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• daily Xray volume imaging for planning radiotherapy

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Association of Radiation Oncology, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate he feasibility of daily X-ray volume imaging during conformal radiotherapy.
Secondary	To provide preliminary data concerning the relative utility of daily X-ray volume image matching compared to fiducial marker image matching.