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

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Trial Information


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.


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Rigid external pelvic immobilization demonstrates a reduction in positioning errors.

Outcome Description:

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.

Outcome Time Frame:

Measured at every treatment fraction for a total of approximately 8.5 weeks

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-15214.1b

NCT ID:

NCT01588938

Start Date:

December 2009

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • radiation therapy
  • Calypso
  • Prostatic Neoplasms

Name

Location

Madigan Healthcare SystemTacoma, Washington  98431