Status:
UNKNOWN
An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
Lead Sponsor:
John Chang, MD
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
Brief Summary
This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained fr...
Detailed Description
The investigators will also be assessing the following: 1. Whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers. 2. Whether polymer-b...
Eligibility Criteria
Inclusion
- Histologically confirmed prostate adenocarcinoma
- diagnosis of low risk or intermediate risk prostate cancer
- approved for proton therapy treatment at CDH ProCure Proton Therapy Center
- prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure
- capable of receiving an MRI of the pelvis region for prostate localization
- the prostate gland of eligible patients must be capable of imaging from an anterior trans-abdominal ultrasound as determined by the treating investigator
- must be fluent in the English language; must be able to provide written study consent
Exclusion
- Evidence of a large TURP defect per investigator discretion
- previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery
- previous pelvic radiation for prostate cancer
- current grade 2 or above incontinence
- history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area
- prior permanent placement of any metallic or high density material within the prostate
- known allergy to ultrasonic gel
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01478412
Start Date
December 1 2011
Last Update
December 7 2011
Active Locations (1)
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1
ProCure Proton Therapy Center
Warrenville, Illinois, United States, 60555