Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer

March 29, 2011 updated by: Navotek Medical, Ltd.
The study aims to evaluate the safety and performance of the RTPS in patients with localized prostate cancer.The RTPS is an investigational device and requires permanent implantation of a small radioactive fiducial, called the Blip, in the prostate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The high precision of planned radiotherapy treatments requires accurate positioning of the prostate in order to ensure that the tightly conformed dose distribution does not miss the prostate and result in either significant tumor underdosage, an increased dose to the rectum or bladder, or both. Precise delivery has been addressed using a variety of pre-treatment localization systems. The most direct localization of the prostate involves the use of ultrasound, computed tomography (CT), or radiography of permanently implanted fiducial markers.

In this study the safety and performance of a novel investigational tracking system will be evaluated. The Radiation Therapy Positioning System (RTPS) is a radioactive tracking system integrated into the radiotherapy set-up workflow. The System is composed of the Clinical Positioning System (CPS) and a radioactive soft tissue implanted fiducial (Blip), which is permanently implanted in the prostate. By tracking the implanted Blip, the CPS can monitor positional changes prior to and during the treatment.

The accuracy of the RTPS localization will be compared to the CBCT in at least 5 radiation therapy sessions per patient.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Belgium
      • Leuven, Belgium, B - 3000
        • Leuvens Kankerinstituut
  • Netherlands
      • Tilburg, Netherlands
        • Dr. Bernard Verbeeten Institute

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Diagnosis of adenocarcinoma of the prostate.
  2. Male, age greater than or equal to 45 years.
  3. Intact prostate of at least 30g, as estimated by physical estimation and/or ultrasound.
  4. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
  5. Patients must be planned to have external beam radiation as the definitive treatment for their prostate cancer with treatment set-up verification according to a locally fixed protocol.
  6. Patients must have anatomy that will allow an adequate pelvic imaging by CBCT as well as CT scanning.
  7. Organ confined or locally advanced prostate cancer with clinical N category 0 or x, M category 0 or x.
  8. Ability to comply with study visit schedule.
  9. Patient (or legal guardian) understands the study requirements and the investigational procedure and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

  1. Past history of abdominoperineal (A-P) resection.
  2. Planned course of treatment using brachytherapy (permanent brachytherapy seeds or high dose rate [HDR] brachytherapy).
  3. Allergy to local anesthetics.
  4. History of chronic prostatitis.
  5. Patients with history of recent acute and/or chronic bleeding disorders.
  6. Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin or dipyridamole.
  7. Patients for which the maximum body width or the maximum anterior-posterior depth in the abdomino-pelvic region is greater than 40 cm. (Measurements will be made visually with a ruler.)
  8. Patients with a body habitus that the CT bore of the CT/LINAC treatment machine cannot accommodate.
  9. Patients with a prior history of pelvic or prostate radiotherapy.
  10. Patients who have had prior prostate surgery other than a TUR.
  11. Cognitively impaired patients who cannot give informed consent.
  12. Patients with hip replacement by a metal prosthesis.
  13. Patient has participated in, or is planned to participate in, any investigational drug or device study within the past or next 2 months.
  14. Patient who has more than 1μCi of any injected or implanted radioactive material within his body.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device related adverse events by evaluation of the type, frequency and severity of the device, implantation device and/or implantation procedure related adverse events
Time Frame: 6 months
6 months
International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy.
Time Frame: 3 weeks
3 weeks
Successful implantation of the Blip in the prostate
Time Frame: 1 wk
1 wk
Non migration of the Blip as evaluated by measuring the average absolute change in inter-marker distances measured during and at the end of radiotherapy treatment
Time Frame: 10 weeks
10 weeks
Performance of the RTPS in at least five of approximately 40 radiation therapy sessions
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Record target volume movement during at least 5 radiation therapy sessions
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Navotek Medical, Ltd.

Investigators

  • Principal Investigator: Philip MP Poortmans, MD, PhD, Dr. Bernard Verbeeten Instituut
  • Principal Investigator: Willy JM de Kruijf, PhD, Dr. Bernard Verbeeten Instituut
  • Principal Investigator: Karin Haustermans, MD, Leuvens Kankerinstituut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 15, 2009

First Posted (Estimate)

June 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 30, 2011

Last Update Submitted That Met QC Criteria

March 29, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-14-001

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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