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Trial Title:
Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System
NCT ID:
NCT01589939
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Reduced Planning Target Volume
radiation therapy
Calypso
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Summary:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Madigan Healthcare System
Address:
City:
Tacoma
Zip:
98431
Country:
United States
Start date:
March 2009
Completion date:
August 2017
Lead sponsor:
Agency:
U.S. Army Medical Research Acquisition Activity
Agency class:
U.S. Fed
Collaborator:
Agency:
The Geneva Foundation
Agency class:
Other
Source:
U.S. Army Medical Research Acquisition Activity
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01589939
