Cone Beam CT for Daily Image Guidance - Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188786
First received: September 12, 2005
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Procedure: daily Cone Beam CT for imaging guidance for 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 Phase II Feasibility Study of Cone Beam Computed Tomography for Daily Image Guidance in Patients Receiving Dose Escalated Conformal Radiation Therapy for Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer.

Secondary Outcome Measures:
  • To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia.
  • To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia.
  • To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models.

Estimated Enrollment: 30
Study Start Date: April 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188786

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Charles Catton, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Dr Charles Catton, Staff Radiation Oncologist, University Health Network, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00188786     History of Changes
Other Study ID Numbers: UHN REB 05-0037-C
Study First Received: September 12, 2005
Last Updated: February 11, 2011
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 August 18, 2014