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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921193
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : March 30, 2011
Information provided by:
Navotek Medical, Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Radiation Therapy Positioning System (RTPS) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer
Study Start Date : May 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 ]
  2. International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy. [ Time Frame: 3 weeks ]
  3. Successful implantation of the Blip in the prostate [ Time Frame: 1 wk ]
  4. 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 ]
  5. Performance of the RTPS in at least five of approximately 40 radiation therapy sessions [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Record target volume movement during at least 5 radiation therapy sessions [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00921193

Leuvens Kankerinstituut
Leuven, Belgium, B - 3000
Dr. Bernard Verbeeten Institute
Tilburg, Netherlands
Sponsors and Collaborators
Navotek Medical, Ltd.
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

Responsible Party: Tal Shchory, COO, Navotek Medical ltd Identifier: NCT00921193     History of Changes
Other Study ID Numbers: 20-14-001
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: March 30, 2011
Last Verified: March 2011

Keywords provided by Navotek Medical, Ltd.:
radiation Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases