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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Radiation Therapy Positioning System (RTPS)

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate, fiducials, radiation Therapy, Tracking, Localization

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of adenocarcinoma of the prostate.
Male, age greater than or equal to 45 years.
Intact prostate of at least 30g, as estimated by physical estimation and/or ultrasound.
ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
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.
Patients must have anatomy that will allow an adequate pelvic imaging by CBCT as well as CT scanning.
Organ confined or locally advanced prostate cancer with clinical N category 0 or x, M category 0 or x.
Ability to comply with study visit schedule.
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:

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.
History of chronic prostatitis.
Patients with history of recent acute and/or chronic bleeding disorders.
Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin or dipyridamole.
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.)
Patients with a body habitus that the CT bore of the CT/LINAC treatment machine cannot accommodate.
Patients with a prior history of pelvic or prostate radiotherapy.
Patients who have had prior prostate surgery other than a TUR.
Cognitively impaired patients who cannot give informed consent.
Patients with hip replacement by a metal prosthesis.
Patient has participated in, or is planned to participate in, any investigational drug or device study within the past or next 2 months.
Patient who has more than 1μCi of any injected or implanted radioactive material within his body.

Sites / Locations

Leuvens Kankerinstituut
Dr. Bernard Verbeeten Institute

Outcomes

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

International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy.

Successful implantation of the Blip in the prostate

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

Performance of the RTPS in at least five of approximately 40 radiation therapy sessions

Secondary Outcome Measures

Record target volume movement during at least 5 radiation therapy sessions

Full Information

NCT ID

NCT00921193

First Posted

June 15, 2009

Last Updated

March 29, 2011

Sponsor

Navotek Medical, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00921193

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Navotek Medical, Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate, fiducials, radiation Therapy, Tracking, Localization

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Radiation Therapy Positioning System (RTPS)

Primary Outcome Measure Information:

Title

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

Title

International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy.

Time Frame

3 weeks

Title

Successful implantation of the Blip in the prostate

Time Frame

1 wk

Title

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

Title

Performance of the RTPS in at least five of approximately 40 radiation therapy sessions

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Record target volume movement during at least 5 radiation therapy sessions

Time Frame

8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate. Male, age greater than or equal to 45 years. Intact prostate of at least 30g, as estimated by physical estimation and/or ultrasound. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1. 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. Patients must have anatomy that will allow an adequate pelvic imaging by CBCT as well as CT scanning. Organ confined or locally advanced prostate cancer with clinical N category 0 or x, M category 0 or x. Ability to comply with study visit schedule. 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: 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. History of chronic prostatitis. Patients with history of recent acute and/or chronic bleeding disorders. Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin or dipyridamole. 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.) Patients with a body habitus that the CT bore of the CT/LINAC treatment machine cannot accommodate. Patients with a prior history of pelvic or prostate radiotherapy. Patients who have had prior prostate surgery other than a TUR. Cognitively impaired patients who cannot give informed consent. Patients with hip replacement by a metal prosthesis. Patient has participated in, or is planned to participate in, any investigational drug or device study within the past or next 2 months. Patient who has more than 1μCi of any injected or implanted radioactive material within his body.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip MP Poortmans, MD, PhD

Organizational Affiliation

Dr. Bernard Verbeeten Instituut

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Willy JM de Kruijf, PhD

Organizational Affiliation

Dr. Bernard Verbeeten Instituut

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Karin Haustermans, MD

Organizational Affiliation

leuvens kankerinstituut

Official's Role

Principal Investigator

Facility Information:

Facility Name

Leuvens Kankerinstituut

City

Leuven

ZIP/Postal Code

B - 3000

Country

Belgium

Facility Name

Dr. Bernard Verbeeten Institute

City

Tilburg

Country

Netherlands

12. IPD Sharing Statement

Links:

URL

http://www.navotek.com

Description

sponsor's website

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

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