View Clinical Trial (Medical Research Study)
Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT 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 prospective study evaluates the clinical utility of a novel real-time localization
system allowing for smaller volumes of normal tissue to be included in radiation field and
determines dosimetric parameters and adverse effect profiles of radiation therapy using this
technology. Subjects will have beacon transponders implanted into the prostate to more
precisely localize the position of the organ during radiation therapy. Hypothesis: 1.
Treatment with highly targeted radiation therapy can be delivered in a daily treatment time
consistent with routine clinical practice. 2. Highly targeted radiation therapy with
reduced PTV margin will result in a significant decrease in rectal and bladder volume
treated.
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| Study Summary: |
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This study will seek to establish the clinical feasibility of a novel real-time localization
and tracking system for use of reduced PTV margins during intensity modulated radiation
therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during
radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue
during treatment may allow for several future improvements in prostate radiotherapy
including:
- decreased acute and chronic adverse effects with similar local tumor control
- dose escalation to achieve higher cure rates with similar adverse effects to standard
dose treatment
- hypofractionation to shorten the time of, and lower the expense of, treatment without
increased adverse effects.
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| Criteria: |
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Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
- Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or
equal to 15
- Ability to comply with study schedule
- Age 40 or older
- Zubrod PS 0 or 1
- Signed informed consent
Exclusion Criteria:
- Node positive or metastatic prostate cancer
- Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or
brachytherapy
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of HIV infection
- History of chronic prostatitis or chronic cystitis
- History of bleeding disorder or any active anticoagulation (excluding ASA)
- 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 8).
- Prior history of androgen deprivation therapy has been deleted and these patients are
allowed on study.
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| NCT ID: |
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NCT01589939 |
| 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 21, 2013 |
| Modifications to this listing: |
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