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Daily Target Guided Radiation Therapy Using the Calypso 4D Localization System in Patients Who Have Had a Prostatectomy for Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Dusten Macdonald, MD, Madigan Army Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624623
First Posted: June 20, 2012
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dusten Macdonald, MD, Madigan Army Medical Center
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Dusten Macdonald, MD, Madigan Army Medical Center:

Primary Outcome Measures:
  • Interfraction prostate bed motion [ Time Frame: Approximately 7.5 weeks (36-39 fractions per pt.) ]

    For each fraction, measurements from the registered CTV (clinical target volume) at the midline will be obtained to structures at 3 points to assess for the degree of motion.

    1. Inferior (defined as 8 mm below VUA)
    2. Superior (top of seminal vesicle remnant or superior most CTV slice)
    3. Middle (defined as the slice equally distant from the inferior and superior slices above)

  • Intrafraction prostate bed motion [ Time Frame: Approximately 7.5 weeks (36-39 fractions per pt.) ]
    Calypso session reports measuring intrafraction motion in x,y,z axis will be recorded and analyzed.


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include high risk patients referred for adjuvant or salvage radiation therapy after radical prostatectomy based upon the presence of unfavorable characteristics after prostatectomy, which include positive surgical margins, extracapsular extension of disease, or immediately detectable PSA.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624623


Locations
United States, Washington
Madigan Healthcare System
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
U.S. Army Medical Research Acquisition Activity
Investigators
Principal Investigator: Dusten Macdonald, MD Department of the Army
  More Information

Responsible Party: Dusten Macdonald, MD, MD, MC, Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT01624623     History of Changes
Other Study ID Numbers: W81XWH-08-2-0174, A-15214.3
210016 ( Other Identifier: Madigan Army IRB )
First Submitted: June 18, 2012
First Posted: June 20, 2012
Last Update Posted: September 11, 2015
Last Verified: September 2015

Keywords provided by Dusten Macdonald, MD, Madigan Army Medical Center:
radiation
Calypso
prostatectomy

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