Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Reduced Planning Target Volume, radiation therapy, Calypso
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 40 Years
Gender: Male
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.
Location
Madigan Healthcare System
Tacoma, Washington, United States
Status: Recruiting
Start Date
March 2009
Completion Date
September 2016
Sponsors
U.S. Army Medical Research Acquisition Activity
Source
U.S. Army Medical Research Acquisition Activity
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page