Prostate CancerNCT01624623
Daily Target Guided Radiation Therapy Using the Calypso 4D Localization System in Patients Who Have Had a Prostatectomy for Prostate Cancer
An observational study of Prostate Cancer, run by U.S. Army Medical Research Acquisition Activity at 1 site in United States.
Trial summary
This study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2016
- Phase
- Observational
- 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include high risk patients referred for adjuvant or salvage radiation therapy after radical prostatectomy based upon the presence of unfavorable characteristics after prostatectomy, which include positive surgical margins, extracapsular extension of disease, or immediately detectable PSA.
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate initially managed with prostatectomy with a detectable PSA, positive surgical margins, or extra-prostatic extension.
- Ability to comply with study schedule
- Age 40 or older
- Zubrod PS 0 or 1 (appendix 1)
- Signed informed consent
Who cannot join
- Node positive or metastatic prostate cancer
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of inflammatory bowel disease or connective tissue disease
- History of bleeding disorder or any active anticoagulant or anti-platelet medication which cannot be discontinued safely for transponder placement.
- PT or INR outside normal range for institution
Show all 10Show fewer
- Active implanted devices such as cardiac pacemakers and automatic defibrillators.
- Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
- Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 5).
- History of HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
This study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer.
Improved coverage of the target volume with radiotherapy could result in improved cancer control rates and decreased coverage of surrounding structures potentially decreasing treatment toxicity.
Read the detailed description
This prospective study evaluates the clinical utility of a novel real-time localization system of the prostate bed during adjuvant or salvage radiotherapy after radical prostatectomy. This study will also determine positioning errors using daily cone-beam computed tomography in patients set up with the Calypso 4D Localization System. Subjects will have Beacon® Transponders implanted into the prostate bed. The Calypso 4D Localization System will localize the position of the prostate bed. Cone beam CT will be used daily to measure inter-transponder distance. The Calypso system will also track the prostate bed position in real time during the entire radiation treatment. The treatments will be adjusted as required to ensure accurate treatment of the clinical target volume. The time of, the number, and extent of adjustments will be recorded for analysis.
Daily cone-beam computed tomography images will also be retrospectively analyzed to assess for adequate target coverage. The analysis will be performed retrospectively through manual 3-D registration of the cone-beam CT dataset with the treatment planning CT scan. This information will determine the margins necessary for the PTV using the Calypso 4D Localization System and potentially may allow a reduction in the PTV volumes on future studies.
- Conditions
- Prostate Cancer
- Keywords
- radiation, Calypso, prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Interfraction prostate bed motion
For each fraction, measurements from the registered CTV (clinical target volume) at the midline will be obtained to structures at 3 points to assess for the degree of motion.
- Inferior (defined as 8 mm below VUA)
- Superior (top of seminal vesicle remnant or superior most CTV slice)
- Middle (defined as the slice equally distant from the inferior and superior slices above)
Measured: Approximately 7.5 weeks (36-39 fractions per pt.)
Intrafraction prostate bed motion
Calypso session reports measuring intrafraction motion in x,y,z axis will be recorded and analyzed.
Measured: Approximately 7.5 weeks (36-39 fractions per pt.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startMar 2010
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research Acquisition Activity
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dusten Macdonald, MD, Madigan Army Medical Center
- Investigators
- Dusten Macdonald, MD, Principal investigator, Department of the Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624623
- Sponsor's protocol ID
- W81XWH-08-2-0174, A-15214.3
- Other IDs
- 210016
- Status last verified
- Sep 2015
- First submitted
- 18 Jun 2012
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01624623
- Acronym / sponsor ID
- W81XWH-08-2-0174, A-15214.3
- Conditions
- Prostate Cancer
- Keywords
- radiation, Calypso, prostatectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research Acquisition ActivityUS federal agency
- Study start
- Mar 2010
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 20 Jun 2012 (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.
This study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer.
Improved coverage of the target volume with radiotherapy could result in improved cancer control rates and decreased coverage of surrounding structures potentially decreasing treatment toxicity.
Detailed description
This prospective study evaluates the clinical utility of a novel real-time localization system of the prostate bed during adjuvant or salvage radiotherapy after radical prostatectomy. This study will also determine positioning errors using daily cone-beam computed tomography in patients set up with the Calypso 4D Localization System. Subjects will have Beacon® Transponders implanted into the prostate bed. The Calypso 4D Localization System will localize the position of the prostate bed. Cone beam CT will be used daily to measure inter-transponder distance. The Calypso system will also track the prostate bed position in real time during the entire radiation treatment. The treatments will be adjusted as required to ensure accurate treatment of the clinical target volume. The time of, the number, and extent of adjustments will be recorded for analysis.
Daily cone-beam computed tomography images will also be retrospectively analyzed to assess for adequate target coverage. The analysis will be performed retrospectively through manual 3-D registration of the cone-beam CT dataset with the treatment planning CT scan. This information will determine the margins necessary for the PTV using the Calypso 4D Localization System and potentially may allow a reduction in the PTV volumes on future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include high risk patients referred for adjuvant or salvage radiation therapy after radical prostatectomy based upon the presence of unfavorable characteristics after prostatectomy, which include positive surgical margins, extracapsular extension of disease, or immediately detectable PSA.
Key inclusion criteria (5 listed)
- Histologically confirmed adenocarcinoma of the prostate initially managed with prostatectomy with a detectable PSA, positive surgical margins, or extra-prostatic extension.
- Ability to comply with study schedule
- Age 40 or older
- Zubrod PS 0 or 1 (appendix 1)
- Signed informed consent
Key exclusion criteria (10 listed)
- Node positive or metastatic prostate cancer
- History of prior pelvic radiotherapy
- History of abdominoperineal resection
- History of inflammatory bowel disease or connective tissue disease
- History of bleeding disorder or any active anticoagulant or anti-platelet medication which cannot be discontinued safely for transponder placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interfraction prostate bed motion
Time frame: Approximately 7.5 weeks (36-39 fractions per pt.)
For each fraction, measurements from the registered CTV (clinical target volume) at the midline will be obtained to structures at 3 points to assess for the degree of motion. 1. Inferior (defined as 8 mm below VUA) 2. Superior (top of seminal vesicle remnant or superior most CTV slice) 3. Middle (defined as the slice equally distant from the inferior and superior slices above)
Intrafraction prostate bed motion
Time frame: Approximately 7.5 weeks (36-39 fractions per pt.)
Calypso session reports measuring intrafraction motion in x,y,z axis will be recorded and analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
Dusten Macdonald, MD principal investigator
Department of the Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by U.S. Army Medical Research Acquisition Activity at 1 site 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Interfraction prostate bed motion (time frame: Approximately 7.5 weeks (36-39 fractions per pt.)). The study lists 2 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 11 Sep 2015.