Computed Tomography (CT) Scans Using CT-On-Rails™ to Pinpoint the Location of the Tumor in Treating Patients With Prostate Cancer
NCT ID: NCT00084526
Last Updated: 2010-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2003-11-30
2007-02-28
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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DIAGNOSTIC
Interventions
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computed tomography
ultrasound imaging
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of definitive prostate cancer
* Radiotherapy planned as treatment
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* Not specified
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Principal Investigators
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Steven Feigenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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FCCC-03005
Identifier Type: -
Identifier Source: secondary_id
CDR0000365453
Identifier Type: -
Identifier Source: org_study_id
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