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

45 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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

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.

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

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 1╬╝Ci of any injected or implanted radioactive material
within his body.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Device related adverse events by evaluation of the type, frequency and severity of the device, implantation device and/or implantation procedure related adverse events

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Philip MP Poortmans, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dr. Bernard Verbeeten Instituut


Netherlands: Dutch Health Care Inspectorate

Study ID:




Start Date:

May 2009

Completion Date:

January 2011

Related Keywords:

  • Prostate Cancer
  • Prostate
  • fiducials
  • radiation Therapy
  • Tracking
  • Localization
  • Prostatic Neoplasms