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Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT 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

Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study


This study will seek to establish the clinical feasibility of a novel real-time localization
and tracking system for use of reduced PTV margins during intensity modulated radiation
therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during
radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue
during treatment may allow for several future improvements in prostate radiotherapy
including:

- decreased acute and chronic adverse effects with similar local tumor control

- dose escalation to achieve higher cure rates with similar adverse effects to standard
dose treatment

- hypofractionation to shorten the time of, and lower the expense of, treatment without
increased adverse effects.


Inclusion Criteria:



- Histologically confirmed adenocarcinoma of the prostate

- Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10

- Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or
equal to 15

- Ability to comply with study schedule

- Age 40 or older

- Zubrod PS 0 or 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 HIV infection

- History of chronic prostatitis or chronic cystitis

- History of bleeding disorder or any active anticoagulation (excluding ASA)

- 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 8).

- Prior history of androgen deprivation therapy has been deleted and these patients are
allowed on study.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use

Outcome Description:

During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.

Outcome Time Frame:

Approximately 8.5 weeks (43 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-15214.1a

NCT ID:

NCT01589939

Start Date:

March 2009

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • Reduced Planning Target Volume
  • radiation therapy
  • Calypso
  • Prostatic Neoplasms

Name

Location

Madigan Healthcare SystemTacoma, Washington  98431