View Clinical Trial (Medical Research Study)
Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
| City: |
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Tacoma |
| State: |
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Washington |
| Zip Code: |
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98431 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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This study will evaluate the daily use of a unique daily organ tracking system on target
localization in patients treated with radiation therapy after radical prostatectomy for
prostate cancer.
Improved coverage of the target volume with radiotherapy could result in improved cancer
control rates and decreased coverage of surrounding structures potentially decreasing
treatment toxicity.
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| Study Summary: |
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This prospective study evaluates the clinical utility of a novel real-time localization
system of the prostate bed during adjuvant or salvage radiotherapy after radical
prostatectomy. This study will also determine positioning errors using daily cone-beam
computed tomography in patients set up with the Calypso 4D Localization System. Subjects
will have Beacon® Transponders implanted into the prostate bed. The Calypso 4D Localization
System will localize the position of the prostate bed. Cone beam CT will be used daily to
measure inter-transponder distance. The Calypso system will also track the prostate bed
position in real time during the entire radiation treatment. The treatments will be adjusted
as required to ensure accurate treatment of the clinical target volume. The time of, the
number, and extent of adjustments will be recorded for analysis.
Daily cone-beam computed tomography images will also be retrospectively analyzed to assess
for adequate target coverage. The analysis will be performed retrospectively through manual
3-D registration of the cone-beam CT dataset with the treatment planning CT scan. This
information will determine the margins necessary for the PTV using the Calypso 4D
Localization System and potentially may allow a reduction in the PTV volumes on future
studies.
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| Criteria: |
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Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate initially managed with
prostatectomy with a detectable PSA, positive surgical margins, or extra-prostatic
extension.
- Ability to comply with study schedule
- Age 40 or older
- Zubrod PS 0 or 1 (appendix 1)
- Signed informed consent
Exclusion Criteria:
- Node positive or metastatic prostate cancer
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of inflammatory bowel disease or connective tissue disease
- History of bleeding disorder or any active anticoagulant or anti-platelet medication
which cannot be discontinued safely for transponder placement.
- PT or INR outside normal range for institution
- Active implanted devices such as cardiac pacemakers and automatic defibrillators.
- Prosthetic implants in the pelvic region that contain metal or conductive materials
(eg., an artificial hip).
- Patients with maximum anterior-posterior separation through the torso minus the
height of the center of the prostate greater than 17 cm (technical reason for Calypso
System, see appendix 5).
- History of HIV infection
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| NCT ID: |
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NCT01624623 |
| Primary Contact: |
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Principal Investigator
Dusten Macdonald, MD
Department of the Army
Stephanie Ninneman, RN
Phone: 253-968-2134
Email: stephanie.ninneman@us.army.mil
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tacoma, Washington 98431
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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