Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 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, MD, U.S. Army Medical Research Acquisition Activity
ClinicalTrials.gov Identifier:
NCT01589939
First received: April 26, 2012
Last updated: May 1, 2012
Last verified: May 2012

April 26, 2012
May 1, 2012
March 2009
August 2012   (final data collection date for primary outcome measure)
Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use [ Time Frame: Approximately 8.5 weeks (43 fractions per pt.) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01589939 on ClinicalTrials.gov Archive Site
  • Analyze dosimetric characteristics of treatment planning [ Time Frame: usually within the first 2 weeks after beacon placement (done at simulation CT) ] [ Designated as safety issue: No ]

    Standard methods vs. reduced planning target volume expansions will be analyzed:

    1. Dose Volume Histogram (DVH), bladder and rectum
    2. Volume receiving 77.4Gy by the prescription dose (V77.4Gy), V70Gy, and V50Gy of bladder and rectum
  • Assess incidence of acute bladder and rectal toxicity [ Time Frame: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up) ] [ Designated as safety issue: Yes ]
    toxicity is based on the RTOG/NCI CTC and EPIC quality of life survey.
Same as current
Not Provided
Not Provided
 
Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System
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 prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with localized prostate cancer for whom definitive radiation therapy is planned to the prostate only or prostate and seminal vesicle only, without ajuvant or neoadjuvant hormornal therpy will be referred by the radiation oncololgists and urologists.

Prostate Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2014
August 2012   (final data collection date for primary outcome measure)

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.
Male
40 Years and older
Yes
Contact: Stephanie Ninneman, RN 253-968-2134 stephanie.ninneman@us.army.mil
United States
 
NCT01589939
W81XWH-08-2-0174, A-15214.1a, 207111
Yes
Dusten Macdonald, MD, U.S. Army Medical Research Acquisition Activity
Dusten Macdonald, MD
The Geneva Foundation
Principal Investigator: Dusten Macdonald, MD Department of the Army
U.S. Army Medical Research Acquisition Activity
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP