Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Navotek Medical, Ltd.
ClinicalTrials.gov Identifier:
NCT00921193
First received: June 15, 2009
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Prostate Cancer
 Device: Radiation Therapy Positioning System (RTPS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Navotek Medical, Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Successful implantation of the Blip in the prostate [ Time Frame: 1 wk ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Performance of the RTPS in at least five of approximately 40 radiation therapy sessions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Record target volume movement during at least 5 radiation therapy sessions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921193

Locations
Belgium
Leuvens Kankerinstituut
Leuven, Belgium, B - 3000
Netherlands
Dr. Bernard Verbeeten Institute
Tilburg, Netherlands
Sponsors and Collaborators
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
  More Information

Additional Information:
sponsor's website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tal Shchory, COO, Navotek Medical ltd
ClinicalTrials.gov Identifier: NCT00921193     History of Changes
Other Study ID Numbers: 20-14-001
Study First Received: June 15, 2009
Last Updated: March 29, 2011
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Navotek Medical, Ltd.:
Prostate
fiducials
radiation Therapy
Tracking
Localization

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

ClinicalTrials.gov processed this record on May 19, 2013