Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System
Verified December 2014 by U.S. Army Medical Research Acquisition Activity
The Geneva Foundation
Information provided by (Responsible Party):
Dusten Macdonald, MD, Madigan Army Medical Center
First received: April 26, 2012
Last updated: December 1, 2014
Last verified: December 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||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
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:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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.
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
|Madigan Healthcare System
|Tacoma, Washington, United States, 98431 |
U.S. Army Medical Research Acquisition Activity
The Geneva Foundation
||Dusten Macdonald, MD
||Department of the Army
No publications provided
||Dusten Macdonald, MD, MD, MC, Madigan Army Medical Center
History of Changes
|Other Study ID Numbers:
||W81XWH-08-2-0174, A-15214.1a, 207111
|Study First Received:
||April 26, 2012
||December 1, 2014
||United States: Federal Government
Keywords provided by U.S. Army Medical Research Acquisition Activity:
Reduced Planning Target Volume
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 05, 2015
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site