External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2009 |
| End Date: | August 2016 |
This prospective study at MAMC evaluates the utility of a rigid pelvic external
immobilization compared to limited immobilization using a novel real-time localization
system of the prostate. The sample population will include patients referred to the
radiation oncology services of both facilities for definitive treatment of prostate cancer.
The study will enroll 20 subjects from MAMC and evaluate data on 860 radiation therapy
fractions.
Subjects will have Beacon® Transponders implanted into the prostate to more precisely
localize the position of the organ during radiation therapy. They will be randomized to
rigid pelvic immobilization using a Vac-Lok® system or limited immobilization with a band
around the patient's feet. They will then undergo radiation therapy planning with standard
planning target margins. The Calypso® 4D Localization System will monitor, in real time, the
position of the prostate target and adjust radiation treatments as required to ensure
accurate treatment of the prostate gland. The time of, the number, and extent of adjustments
will be recorded for analysis.
Hypothesis: 1. When treating only the prostate, treatment with rigid pelvic immobilization
is not necessary when using real-time, state-of-the-art motion tracking of the prostate.
immobilization compared to limited immobilization using a novel real-time localization
system of the prostate. The sample population will include patients referred to the
radiation oncology services of both facilities for definitive treatment of prostate cancer.
The study will enroll 20 subjects from MAMC and evaluate data on 860 radiation therapy
fractions.
Subjects will have Beacon® Transponders implanted into the prostate to more precisely
localize the position of the organ during radiation therapy. They will be randomized to
rigid pelvic immobilization using a Vac-Lok® system or limited immobilization with a band
around the patient's feet. They will then undergo radiation therapy planning with standard
planning target margins. The Calypso® 4D Localization System will monitor, in real time, the
position of the prostate target and adjust radiation treatments as required to ensure
accurate treatment of the prostate gland. The time of, the number, and extent of adjustments
will be recorded for analysis.
Hypothesis: 1. When treating only the prostate, treatment with rigid pelvic immobilization
is not necessary when using real-time, state-of-the-art motion tracking of the prostate.
Medical application: This study will seek to determine the utility of rigid external pelvic
immobilization in patients who are set up using real-time, state-of-the-art motion tracking
of the prostate. External immobilization devices have been criticized for being expensive,
uncomfortable, time-consuming to make, occupying a lot of space in the treatment area,
creating difficulties at the time of CT simulation, challenging for obese patients and
obscuring skin marks that can help confirm patient set up. Omitting these devices (if found
to be unnecessary) would potentially decrease treatment costs, improve patient comfort
during treatment, and reduce overall treatment time. In high risk patients, gaining a better
understanding of lymph node positioning relative to Calypso immobilization may allow for
decreased PTV margins and therefore decreased normal tissue irradiated during radiation
therapy.
Objective(s) of the investigation: This study will look at the efficacy of external pelvic
immobilization in definitive radiation therapy of prostate cancer using a unique organ
tracking system.
A. Primary Objective: To determine if rigid external pelvic immobilization demonstrates a
reduction in positioning errors. This will be assessed by determining the median, mean and
range of shifts performed in all 3 dimensions as part of initial isocenter set-up and during
treatment using the Calypso system.
B. Secondary Objectives: The study will determine the simulation time, set up time,
treatment time, total time and number of treatment interventions (repositioning/pausing)
caused by organ/target motion beyond planning target volume (PTV) margin using real time
localization. In the subset of high-risk patients, this study will assess positioning of the
lymph node target using the combination of rigid external pelvic immobilization and the
Calypso system.
immobilization in patients who are set up using real-time, state-of-the-art motion tracking
of the prostate. External immobilization devices have been criticized for being expensive,
uncomfortable, time-consuming to make, occupying a lot of space in the treatment area,
creating difficulties at the time of CT simulation, challenging for obese patients and
obscuring skin marks that can help confirm patient set up. Omitting these devices (if found
to be unnecessary) would potentially decrease treatment costs, improve patient comfort
during treatment, and reduce overall treatment time. In high risk patients, gaining a better
understanding of lymph node positioning relative to Calypso immobilization may allow for
decreased PTV margins and therefore decreased normal tissue irradiated during radiation
therapy.
Objective(s) of the investigation: This study will look at the efficacy of external pelvic
immobilization in definitive radiation therapy of prostate cancer using a unique organ
tracking system.
A. Primary Objective: To determine if rigid external pelvic immobilization demonstrates a
reduction in positioning errors. This will be assessed by determining the median, mean and
range of shifts performed in all 3 dimensions as part of initial isocenter set-up and during
treatment using the Calypso system.
B. Secondary Objectives: The study will determine the simulation time, set up time,
treatment time, total time and number of treatment interventions (repositioning/pausing)
caused by organ/target motion beyond planning target volume (PTV) margin using real time
localization. In the subset of high-risk patients, this study will assess positioning of the
lymph node target using the combination of rigid external pelvic immobilization and the
Calypso system.
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Stage T1 -T3a, N0 or NX, M0
- 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
- Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or
brachytherapy
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of inflammatory bowel disease or connective tissue disease
- History of HIV infection
- History of chronic prostatitis or chronic cystitis
- History of bleeding disorder or any active anticoagulation (excluding ASA) which
cannot be safely discontinued for beacon 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).
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