NCT00084526

Computed Tomography (CT) Scans Using CT-On-Rails™ to Pinpoint the Location of the Tumor in Treating Patients With Prostate Cancer

Evaluation of Daily CT Scans Using CT on Rails for Localization in the Treatment of Prostate Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: New imaging procedures such as CT-on-rails™ may improve the ability to pinpoint the location of the tumor and decrease radiation therapy damage to healthy tissue. PURPOSE: This phase I/II trial is studying how well computed tomography (CT) scans using CT-on-rails™ work in pinpointing the location of the tumor in patients with prostate cancer.

Detailed description

OBJECTIVES: Primary * Validate the software for CT-on-rails™ by comparing prostate target localization via daily ultrasound vs computed tomography (CT) in patients undergoing radiotherapy for prostate cancer. Secondary * Determine the potential benefit of using fiducials in the prostate of patients undergoing daily CT scans and/or ultrasounds for localization. * Determine the intra- and inter-radiation treatment setup and target position uncertainties, in terms of isocenter coordinates in space, using both the ultrasound and CT scans compared to the coordinates of the isocenter determined at simulation, in these patients. OUTLINE: This is a pilot study. * Phase I: Patients undergo computed tomography (CT) using CT-on-rails™ twice weekly. Patients undergo BAT™ ultrasound daily for prostate localization. Patients undergo concurrent daily radiotherapy off study after imaging. After radiotherapy treatment is complete, patients continue to undergo scanning using CT-on-rails™ twice weekly. * Phase II: Patients undergo local anesthesia and surgical insertion of gold fiducial markers into the prostate. After 1 week, patients undergo a daily CT scan using CT-on-rails™ and bi-weekly BAT™ ultrasound. Patients undergo daily radiotherapy off study after imaging. After radiotherapy treatment is complete, patients continue to undergo scanning using CT-on-rails™ twice weekly. PROJECTED ACCRUAL: A total of 40 patients (20 per study phase) will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	computed tomography
PROCEDURE	ultrasound imaging

Timeline

• Start date: 2003-11-01
• Completion: 2007-02-01
• First posted: 2004-06-11
• Last updated: 2010-02-12

Locations

1 site across 1 country: United States