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Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study


N/A
40 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study


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 BeaconĀ® 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Interfraction prostate bed motion

Outcome Description:

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

Outcome Time Frame:

Approximately 7.5 weeks (36-39 fractions per pt.)

Safety Issue:

No

Principal Investigator

Dusten Macdonald, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of the Army

Authority:

United States: Federal Government

Study ID:

W81XWH-08-2-0174, A-15214.3

NCT ID:

NCT01624623

Start Date:

March 2010

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • radiation
  • Calypso
  • prostatectomy
  • Prostatic Neoplasms

Name

Location

Madigan Healthcare SystemTacoma, Washington  98431