Positioning and Tracking the Prostate During External Beam Radiation

April 26, 2016 updated by: Varian, a Siemens Healthineers Company

Beacon® Transponder Implantation and Localization in the Prostate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 slightly within the pelvis and that its position varies a few millimeters from day to day. There are several methods used to position the body and the prostate accurately at the beginning of each radiation therapy session.

One of the standard methods is to permanently implant small markers (gold spheres or cylinders) in the prostate and use x-rays in the radiation therapy treatment room to determine whether the markers are in the correct position. If the markers are in the correct position, then the assumption is that the prostate also is in the correct position. If the markers are not in the correct position on the x-ray, then the table that the patient lies on can be shifted so that the markers are in the right place.

In this study the Beacon® transponder will be used in place of the standard gold marker. During the radiation therapy visits, the patient position in the treatment room will be corrected using the Beacon transponder with an investigational system, called the Calypso® 4D Localization System. The Calypso system consists of a flat panel, placed over the pelvis and connected to a computer, which monitors the position of the Beacon transponders within the prostate. During five radiation therapy appointments and one extra visit, the position of the markers in the prostate will be confirmed with x-rays.

The Beacon transponder is a small glass cylinder that contains a tiny electrical circuit. The glass vial is completely sealed and separates the internal components (i.e., the electrical circuit) from the rest of the body. The glass vial is approximately one-third of one inch long and one-tenth of one inch in diameter. Three Beacon transponders will be implanted in the prostate. They will be permanently implanted.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Healthcare - Osborn
    • California
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center Orlando
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • The Nebraska Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44192
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group Assignment
Calypso® 4D Localization System
Device: Calypso® 4D Localization System
Localization of prostate irradiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic verification of at least five of approximately 40 radiation treatment days
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Preference Questionnaire and SF 36 Health Survey at five radiation treatment days
Time Frame: 8 week
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Varian, a Siemens Healthineers Company

Investigators

  • Study Director: Lisa Levine, Ph.D., Varian, a Siemens Healthineers Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 22, 2005

First Submitted That Met QC Criteria

July 22, 2005

First Posted (Estimate)

July 26, 2005

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prostate Stage 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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