Positioning and Tracking the Prostate During External Beam Radiation

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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 delivery. The clinical study involves using an investigational device, the Calypso® 4D Localization System, and requires permanent implantation of three small sensors called Beacon® transponders in the prostate.

Key facts

Study ID

NCT00123838

Run by

Varian, a Siemens Healthineers Company

People needed

43

Starts

2005-07-01

Expected to finish

2008-09-01

Last updated by the study team

2016-04-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scottsdale Healthcare - Osborn — Scottsdale, Arizona, United States
• Sharp Memorial Hospital — San Diego, California, United States
• M.D. Anderson Cancer Center Orlando — Orlando, Florida, United States
• The Nebraska Medical Center — Omaha, Nebraska, United States
• The Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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