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External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by U.S. Army Medical Research Acquisition Activity.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Geneva Foundation
Information provided by (Responsible Party):
Dusten Macdonald, U.S. Army Medical Research Acquisition Activity
ClinicalTrials.gov Identifier:
NCT01588938
First received: April 26, 2012
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research Acquisition Activity:

Primary Outcome Measures:
  • Rigid external pelvic immobilization demonstrates a reduction in positioning errors. [ Time Frame: Measured at every treatment fraction for a total of approximately 8.5 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: Measured at simluation and every treatment fraction for a total of approximately 10 weeks ] [ Designated as safety issue: No ]
    During each radiation treatment fraction, therapists will record these timepoints and number/duaration of treatment inverventions.

  • Positioning of the lymph node target using the combination of rigid external pelvic immobilization and the Calypso system. [ Time Frame: Measured at every treatment fraction for a total of approximately 8.5 weeks ] [ Designated as safety issue: No ]
    This will be analyzed in the subset of high-risk patients.


Estimated Enrollment: 20
Study Start Date: December 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This study will include patients with prostate cancer for whom definitive radiation therapy is planned to the prostate. Patients will be referred from Urology and Radiation Oncology.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588938

Contacts
Contact: Stephanie Ninneman, RN 253-968-2134 stephanie.ninneman@us.army.mil

Locations
United States, Washington
Madigan Healthcare System Recruiting
Tacoma, Washington, United States, 98431
Principal Investigator: Dusten Macdonald, MD,MC         
Sponsors and Collaborators
Dusten Macdonald
The Geneva Foundation
Investigators
Principal Investigator: Dusten Macdonald, MD Department of the Army
  More Information

No publications provided

Responsible Party: Dusten Macdonald, MD, MC, U.S. Army Medical Research Acquisition Activity
ClinicalTrials.gov Identifier: NCT01588938     History of Changes
Other Study ID Numbers: W81XWH-08-2-0174, A-15214.1b, W81XWH-08-2-0174, 209099
Study First Received: April 26, 2012
Last Updated: April 27, 2012
Health Authority: United States: Federal Government

Keywords provided by U.S. Army Medical Research Acquisition Activity:
radiation therapy
Calypso

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014