External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Prostate Cancer
- 发起方
- U.S. Army Medical Research Acquisition Activity
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rigid external pelvic immobilization demonstrates a reduction in positioning errors.
- 最后更新
- 9年前
概览
简要总结
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.
详细描述
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.
研究者
Dusten Macdonald, MD
MD, MC
Madigan Army Medical Center
入排标准
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Rigid external pelvic immobilization demonstrates a reduction in positioning errors.
时间窗: Measured at every treatment fraction for a total of approximately 8.5 weeks
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.
次要结局
- 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.(Measured at simluation and every treatment fraction for a total of approximately 10 weeks)
- Positioning of the lymph node target using the combination of rigid external pelvic immobilization and the Calypso system.(Measured at every treatment fraction for a total of approximately 8.5 weeks)