Prostate CancerNCT00123838
Positioning and Tracking the Prostate During External Beam Radiation
A study testing Calypso® 4D Localization System in people with Prostate Cancer, run by Varian, a Siemens Healthineers Company at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Calypso® 4D Localization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2005to Sep 2008
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Histologically confirmed diagnosis of prostate cancer
- Intact prostate (minor transurethral resection of the prostate [TURP] defects are allowed at the discretion of the investigator)
- Ability to comply with study visit schedule
Who cannot join
- Prior treatment for prostate cancer.
- Prostate cancer stage IV (metastatic disease).
- Patients who are not eligible for prostate biopsy.
- 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.
Show all 13Show fewer
- Patients with any permanently implanted medical devices that have an energy source, such as pacemakers, defibrillators, neurostimulators, and drug infusion pumps; this also includes prosthetic implants in the abdomen or pelvis, such as an artificial hip; or vascular implants such as arterial stents or stent-grafts for aortic aneurysms. This does not include surgical clips, staples or coronary stents.
- History of chronic prostatitis.
- Patients with a history of recent acute and/or chronic bleeding disorders.
- Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin.
- Patients for which the maximum anterior-posterior separation through the torso minus the height of the center of the prostate is greater than 23 cm. (Measurements will be made visually with a ruler.)
- Baseline evaluation shows an INR or PTT outside of the normal range for the institution; platelet count < 75,000 mm3; or creatinine > 2.0 mg/dl.
- Any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in a clinical trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Cleveland Clinic
Cleveland, Ohio, 44192
The Nebraska Medical Center
Omaha, Nebraska, 68105
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806
Sharp Memorial Hospital
San Diego, California, 92123
Scottsdale Healthcare - Osborn
Scottsdale, Arizona, 85260
About this study
Official title: Beacon® Transponder Implantation and Localization in the Prostate
The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy delivery. The clinical study involves using an investigational device, the Calypso® 4D Localization System, and requires permanent implantation of three small sensors called Beacon® transponders in the prostate.
Read the detailed description
The goal for prostate radiation therapy is to give a high dose of radiation to the prostate and a minimal dose to the healthy tissue around the prostate. It is well known that the prostate moves slightly within the pelvis and that its position varies a few millimeters from day to day. There are several methods used to position the body and the prostate accurately at the beginning of each radiation therapy session.
One of the standard methods is to permanently implant small markers (gold spheres or cylinders) in the prostate and use x-rays in the radiation therapy treatment room to determine whether the markers are in the correct position. If the markers are in the correct position, then the assumption is that the prostate also is in the correct position. If the markers are not in the correct position on the x-ray, then the table that the patient lies on can be shifted so that the markers are in the right place.
In this study the Beacon® transponder will be used in place of the standard gold marker. During the radiation therapy visits, the patient position in the treatment room will be corrected using the Beacon transponder with an investigational system, called the Calypso® 4D Localization System. The Calypso system consists of a flat panel, placed over the pelvis and connected to a computer, which monitors the position of the Beacon transponders within the prostate. During five radiation therapy appointments and one extra visit, the position of the markers in the prostate will be confirmed with x-rays.
The Beacon transponder is a small glass cylinder that contains a tiny electrical circuit. The glass vial is completely sealed and separates the internal components (i.e., the electrical circuit) from the rest of the body. The glass vial is approximately one-third of one inch long and one-tenth of one inch in diameter. Three Beacon transponders will be implanted in the prostate. They will be permanently implanted.
- Conditions
- Prostate Cancer
- Being tested
- Calypso® 4D Localization System
- Keywords
- Prostate, Cancer, Radiotherapy, Neoplasm, Localization, Tracking, Cancer of Prostate, Neoplasms, Prostate
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calypso® 4D Localization SystemDevice
Localization of prostate irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | Calypso® 4D Localization System Receives: Device: Calypso® 4D Localization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic verification of at least five of approximately 40 radiation treatment days
Measured: 8 weeks
Secondary outcomes (1)
Patient Preference Questionnaire and SF 36 Health Survey at five radiation treatment days
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionSep 2008
- Study completionSep 2008
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Levine, Ph.D., Study director, Varian, a Siemens Healthineers Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123838
- Sponsor's protocol ID
- Prostate Stage 3
- Status last verified
- Apr 2016
- First submitted
- 22 Jul 2005
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beacon® Transponder Implantation and Localization in the Prostate
- ClinicalTrials.gov ID
- NCT00123838
- Acronym / sponsor ID
- Prostate Stage 3
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Radiotherapy, Neoplasm, Localization, Tracking, Cancer of Prostate, Neoplasms, Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 Jul 2005 (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 purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy delivery. The clinical study involves using an investigational device, the Calypso® 4D Localization System, and requires permanent implantation of three small sensors called Beacon® transponders in the prostate.
Detailed description
The goal for prostate radiation therapy is to give a high dose of radiation to the prostate and a minimal dose to the healthy tissue around the prostate. It is well known that the prostate moves slightly within the pelvis and that its position varies a few millimeters from day to day. There are several methods used to position the body and the prostate accurately at the beginning of each radiation therapy session.
One of the standard methods is to permanently implant small markers (gold spheres or cylinders) in the prostate and use x-rays in the radiation therapy treatment room to determine whether the markers are in the correct position. If the markers are in the correct position, then the assumption is that the prostate also is in the correct position. If the markers are not in the correct position on the x-ray, then the table that the patient lies on can be shifted so that the markers are in the right place.
In this study the Beacon® transponder will be used in place of the standard gold marker. During the radiation therapy visits, the patient position in the treatment room will be corrected using the Beacon transponder with an investigational system, called the Calypso® 4D Localization System. The Calypso system consists of a flat panel, placed over the pelvis and connected to a computer, which monitors the position of the Beacon transponders within the prostate. During five radiation therapy appointments and one extra visit, the position of the markers in the prostate will be confirmed with x-rays.
The Beacon transponder is a small glass cylinder that contains a tiny electrical circuit. The glass vial is completely sealed and separates the internal components (i.e., the electrical circuit) from the rest of the body. The glass vial is approximately one-third of one inch long and one-tenth of one inch in diameter. Three Beacon transponders will be implanted in the prostate. They will be permanently implanted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Device: Calypso® 4D Localization SystemCalypso® 4D Localization System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Histologically confirmed diagnosis of prostate cancer
- Intact prostate (minor transurethral resection of the prostate [TURP] defects are allowed at the discretion of the investigator)
- Ability to comply with study visit schedule
Key exclusion criteria (13 listed)
- Prior treatment for prostate cancer.
- Prostate cancer stage IV (metastatic disease).
- Patients who are not eligible for prostate biopsy.
- Past history of abdominoperineal (A-P) resection.
- Planned course of treatment using brachytherapy (permanent brachytherapy seeds or high dose rate [HDR] brachytherapy).
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 |
|---|---|---|
| Calypso® 4D Localization SystemLocalization of prostate irradiation. | Device | Single Group Assignment |
Primary outcome
Radiographic verification of at least five of approximately 40 radiation treatment days
Time frame: 8 weeks
1 secondary outcome
Patient Preference Questionnaire and SF 36 Health Survey at five radiation treatment days
Time frame: 8 week
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 28 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Lisa Levine, Ph.D. study director
Varian, a Siemens Healthineers Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calypso® 4D Localization System in people with Prostate Cancer, run by Varian, a Siemens Healthineers Company at 5 sites in United States.
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 4 inclusion and 13 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Radiographic verification of at least five of approximately 40 radiation treatment days (time frame: 8 weeks). 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 28 Apr 2016.