Cone Beam CT for Daily Image Guidance - Prostate Cancer

NCT00188786 | Completed Phase 2

• 1 other identifier: UHN REB 05-0037-C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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.

Interventions

daily Cone Beam CT for imaging guidance for radiotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inflammatory bowel disease or collagen vascular disease

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Charles Catton, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 15, 2011

Record last verified: 2011-02

Locations

CA (1)