Status:
COMPLETED
Positioning and Tracking the Prostate During External Beam Radiation
Lead Sponsor:
Varian, a Siemens Healthineers Company
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy deliv...
Detailed Description
The goal for prostate radiation therapy is to give a high dose of radiation to the prostate and a minimal dose to the healthy tissue around the prostate. It is well known that the prostate moves sligh...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Histologically confirmed diagnosis of prostate cancer
- Intact prostate (minor transurethral resection of the prostate \[TURP\] defects are allowed at the discretion of the investigator)
- Ability to comply with study visit schedule
Exclusion
- Prior treatment for prostate cancer.
- Prostate cancer stage IV (metastatic disease).
- Patients who are not eligible for prostate biopsy.
- Past history of abdominoperineal (A-P) resection.
- Planned course of treatment using brachytherapy (permanent brachytherapy seeds or high dose rate \[HDR\] brachytherapy).
- Allergy to local anesthetics.
- Patients with any permanently implanted medical devices that have an energy source, such as pacemakers, defibrillators, neurostimulators, and drug infusion pumps; this also includes prosthetic implants in the abdomen or pelvis, such as an artificial hip; or vascular implants such as arterial stents or stent-grafts for aortic aneurysms. This does not include surgical clips, staples or coronary stents.
- History of chronic prostatitis.
- Patients with a history of recent acute and/or chronic bleeding disorders.
- Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin.
- Patients for which the maximum anterior-posterior separation through the torso minus the height of the center of the prostate is greater than 23 cm. (Measurements will be made visually with a ruler.)
- Baseline evaluation shows an INR or PTT outside of the normal range for the institution; platelet count \< 75,000 mm3; or creatinine \> 2.0 mg/dl.
- Any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in a clinical trial
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00123838
Start Date
July 1 2005
End Date
September 1 2008
Last Update
April 28 2016
Active Locations (5)
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1
Scottsdale Healthcare - Osborn
Scottsdale, Arizona, United States, 85260
2
Sharp Memorial Hospital
San Diego, California, United States, 92123
3
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
4
The Nebraska Medical Center
Omaha, Nebraska, United States, 68105