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
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research Acquisition Activity:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589939

Contacts
Contact: Stephanie Ninneman, RN 253-968-2134 stephanie.ninneman@us.army.mil

Locations
United States, Washington
Madigan Healthcare System Recruiting
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Dusten Macdonald, MD
The Geneva Foundation
Investigators
Principal Investigator: Dusten Macdonald, MD Department of the Army
  More Information

No publications provided

Responsible Party: Dusten Macdonald, MD, MD, MC, U.S. Army Medical Research Acquisition Activity
ClinicalTrials.gov Identifier: NCT01589939     History of Changes
Other Study ID Numbers: W81XWH-08-2-0174, A-15214.1a, 207111
Study First Received: April 26, 2012
Last Updated: May 1, 2012
Health Authority: United States: Federal Government

Keywords provided by U.S. Army Medical Research Acquisition Activity:
Reduced Planning Target Volume
radiation therapy
Calypso

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

ClinicalTrials.gov processed this record on October 23, 2014