Prostate CancerNCT00921193
Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer
A study testing Radiation Therapy Positioning System (RTPS) in people with Prostate Cancer, run by Navotek Medical, Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation Therapy Positioning System (RTPS)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Radiation Therapy Positioning System (RTPS)
- Keywords
- Prostate, fiducials, radiation Therapy, Tracking, Localization
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Therapy Positioning System (RTPS)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related adverse events by evaluation of the type, frequency and severity of the device, implantation device and/or implantation procedure related adverse events
Measured: 6 months
International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy.
Measured: 3 weeks
Successful implantation of the Blip in the prostate
Measured: 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
Measured: 10 weeks
Performance of the RTPS in at least five of approximately 40 radiation therapy sessions
Measured: 8 weeks
Secondary outcomes (1)
Record target volume movement during at least 5 radiation therapy sessions
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navotek Medical, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip MP Poortmans, MD, PhD, Principal investigator, Dr. Bernard Verbeeten InstituutWilly JM de Kruijf, PhD, Principal investigator, Dr. Bernard Verbeeten InstituutKarin Haustermans, MD, Principal investigator, Leuvens Kankerinstituut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921193
- Sponsor's protocol ID
- 20-14-001
- Status last verified
- Mar 2011
- First submitted
- 15 Jun 2009
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radiation Therapy Positioning System (RTPS) in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00921193
- Acronym / sponsor ID
- 20-14-001
- Conditions
- Prostate Cancer
- Keywords
- Prostate, fiducials, radiation Therapy, Tracking, Localization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Navotek Medical, Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation Therapy Positioning System (RTPS) | Device | – |
Primary outcome
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
International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy.
Time frame: 3 weeks
Successful implantation of the Blip in the prostate
Time frame: 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
Performance of the RTPS in at least five of approximately 40 radiation therapy sessions
Time frame: 8 weeks
1 secondary outcome
Record target volume movement during at least 5 radiation therapy sessions
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2011.
- sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip MP Poortmans, MD, PhD principal investigator
Dr. Bernard Verbeeten Instituut
Willy JM de Kruijf, PhD principal investigator
Dr. Bernard Verbeeten Instituut
Karin Haustermans, MD principal investigator
Leuvens Kankerinstituut
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy Positioning System (RTPS) in people with Prostate Cancer, run by Navotek Medical, Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2011.