Cone Beam CT for Daily Image Guidance - Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

A Phase II Feasibility Study of Cone Beam Computed Tomography for Daily Image Guidance in Patients Receiving Dose Escalated Conformal Radiation Therapy for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188786
• Other study ID #: UHN REB 05-0037-C
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: February 11, 2011
• Start date: April 2005
• Est. completion date: April 2010

Study information

• Verified date: February 2011
• 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 radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of adenocarcinoma of the prostate

• Patient undergoing dose escalated conformal external beam radiation therapy

• Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score <8, Clinical T category <T3, Clinical N category 0 or X, M category 0 or X

• Age 18 years or older

• ECOG performance status 0 or 1

• Informed consent

Exclusion Criteria:

• Inflammatory bowel disease or collagen vascular disease

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 Cone Beam CT for imaging guidance for radiotherapy

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer.
Secondary	To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia.
Secondary	To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia.
Secondary	To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models.