Prostate CancerNCT00499421
Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to evaluate a system for localizing (targeting for treatment) the prostate for external beam radiation therapy. The system will be used to locate the prostate before treatment and to measure movement of the prostate during treatment. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Computed Tomography (CT) Scan
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2005to 26 Jan 2023
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants with prostate cancer that will be treated with external beam radiation therapy.
Who may be able to join
- Patients with pathologic diagnosis of prostate cancer.
- Patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.
- Patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.
- Patients must be able to tolerate frequent (e.g. three CT scans per week) CT scanning.
- Patients must be able to lie flat and still for the duration of the fiducial-based localization and CT scanning sessions.
- Patients must have anatomy that will allow an adequate pelvic image on portal imaging and CT scanning.
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- If patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.
- Patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.
- Patients must understand and sign informed consent.
Who cannot join
- Patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.
- Patients with an estimated prostate volume of less than 20 cc.
- Patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.
- Patients who have had previous radiation therapy to the pelvis.
- Patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).
- Patients with a body habitus that the CT bore of the CT/Linac treatment machine cannot accommodate (i.e. height greater than 6' 3" or body weight greater than 300 pounds).
- Patients on anticoagulant medication (e.g., coumadin, clopidogrel, low-molecular weight heparin) other than aspirin will not be eligible. Patients on aspirin should discontinue aspirin 7 days prior to fiducial placement and for 5 days afterward.
- Patients with hip prostheses will not be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Evaluation of Intraprostatic Fiducial Markers For Targeting of External Beam Radiation Therapy
The goal of this clinical research study is to evaluate a system for localizing (targeting for treatment) the prostate for external beam radiation therapy. The system will be used to locate the prostate before treatment and to measure movement of the prostate during treatment. The data collected with the system will be compared to CT images taken during the course of your radiation therapy treatment. Researchers will try to use this information to verify the performance of the system, which could lead to improved positioning and tracking of the prostate during treatment.
Read the detailed description
The prostate may change position on a day-to-day basis due to differences in positioning, muscle tone, rectal filling, and bladder filling. Soft tissue like the prostate is not usually visible with normal x-rays, but certain metals like gold are visible. Many institutions are using an FDA-approved system (fiducial system), the one being used in this study, which involves implanting small gold markers to locate the prostate on a daily basis. This system allows the prostate to be located before treatment, which may improve radiation delivery to the prostate and decrease radiation exposure to normal tissue such as the rectum and bladder. The ability of this system to provide information on the location of the prostate before treatment should allow for more precise and accurate radiation treatment of prostate cancer.
The small implanted gold markers are 3 mm long and 1 mm wide (about the size of a grain of rice). If you agree to take part in this study, 3 markers will be permanently implanted into your prostate using a needle similar to the biopsy needle used to diagnose your cancer.
Treatment for prostate cancer during this research study will not be different from the MD Anderson standard of care. You will have intensity-modulated radiation therapy (IMRT) treatment for the prostate cancer performed using the CT-Linac treatment machine (ExaCT, Varian Medical Systems, Palo Alto, CA). This machine will have the same IMRT capabilities as other treatment machines in the Radiation Oncology Department.
During the study, the position of the gold markers seen on x-ray will be used to make adjustments to the position of your prostate for your radiation therapy treatment. The positions reported by the fiducial system will be recorded and used for daily treatment.
Three (3) times per week, you will have a CT scan of your prostate. The CT scans will be performed just before the delivery of radiation. Radiotherapists will assist you onto the treatment table and position it for your treatment. The treatment table will then be rotated 180 degrees from the treatment machine and the CT scan of your prostate will be performed. After the CT scan, which will take about 5-8 minutes, the couch will be rotated back to the original position.
A trans-abdominal ultrasound of your prostate will also be performed twice per week for the first two weeks and then once a week from then on while you are on study. The MD Anderson staff and researchers will analyze the changes in prostate movement during radiation therapy using the scanned CT images and ultrasound images and compare them with positional changes displayed by the fiducial-based system.
Targeting of your prostate on a daily basis will be performed using the fiducial-based system. This will involve performing a pair of x-rays before your treatment. A shift will be made if needed using the implanted prostate markers. The position of the seeds after the shift will be routinely verified with another pair of x-rays. After alignment has occurred, a radiation treatment will then be delivered.
This is an investigational study. The fiducial-based system is FDA-approved. A total of 20 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Computed Tomography (CT) Scan
- Keywords
- Prostate Cancer, External Beam Radiation Therapy, Fiducial Markers, Acculoc System, Center Of Mass, EBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography (CT) ScanProcedure or surgery
CT scan of the prostate three times a week, just before the delivery of radiation.
| Study group | Role | What they receive |
|---|---|---|
| CT Scan | CT Scan with Fiducial markers + external beam radiation therapy Receives: Procedure: Computed Tomography (CT) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Prostate Position Calculated using both fiducials and CT methods
Prostate position determined by center of mass (COM) of prostate. COM calculated by planning system based on contours of prostate on each CT slice. Prostate position assessed as the mean position of the three implanted fiducial markers (MPIF), which is computed using software provided by the commercial fiducial system. These two points (COM and MPIF) expressed using same coordinate system, whose origin is positioned treatment isocenter. Difference between the two points (COM and MPIF) defines a vector in 3-dimensional space. The three dimensions correspond to the right-left (RL), anterior-posterior (AP), and superior-inferior (SI) directions.
Measured: At time of treatment planning (time 0) and at 24 additional time points during the 8-week course of radiotherapy (3 times per week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study start14 Sep 2005
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seungtaek Choi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499421
- Sponsor's protocol ID
- 2004-0428
- Status last verified
- Mar 2023
- First submitted
- 10 Jul 2007
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraprostatic Fiducial Markers For Targeting of External Beam Radiation Therapy
- ClinicalTrials.gov ID
- NCT00499421
- Acronym / sponsor ID
- 2004-0428
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, External Beam Radiation Therapy, Fiducial Markers, Acculoc System, Center Of Mass, EBRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Sep 2005 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 11 Jul 2007 (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 goal of this clinical research study is to evaluate a system for localizing (targeting for treatment) the prostate for external beam radiation therapy. The system will be used to locate the prostate before treatment and to measure movement of the prostate during treatment. The data collected with the system will be compared to CT images taken during the course of your radiation therapy treatment. Researchers will try to use this information to verify the performance of the system, which could lead to improved positioning and tracking of the prostate during treatment.
Detailed description
The prostate may change position on a day-to-day basis due to differences in positioning, muscle tone, rectal filling, and bladder filling. Soft tissue like the prostate is not usually visible with normal x-rays, but certain metals like gold are visible. Many institutions are using an FDA-approved system (fiducial system), the one being used in this study, which involves implanting small gold markers to locate the prostate on a daily basis. This system allows the prostate to be located before treatment, which may improve radiation delivery to the prostate and decrease radiation exposure to normal tissue such as the rectum and bladder. The ability of this system to provide information on the location of the prostate before treatment should allow for more precise and accurate radiation treatment of prostate cancer.
The small implanted gold markers are 3 mm long and 1 mm wide (about the size of a grain of rice). If you agree to take part in this study, 3 markers will be permanently implanted into your prostate using a needle similar to the biopsy needle used to diagnose your cancer.
Treatment for prostate cancer during this research study will not be different from the MD Anderson standard of care. You will have intensity-modulated radiation therapy (IMRT) treatment for the prostate cancer performed using the CT-Linac treatment machine (ExaCT, Varian Medical Systems, Palo Alto, CA). This machine will have the same IMRT capabilities as other treatment machines in the Radiation Oncology Department.
During the study, the position of the gold markers seen on x-ray will be used to make adjustments to the position of your prostate for your radiation therapy treatment. The positions reported by the fiducial system will be recorded and used for daily treatment.
Three (3) times per week, you will have a CT scan of your prostate. The CT scans will be performed just before the delivery of radiation. Radiotherapists will assist you onto the treatment table and position it for your treatment. The treatment table will then be rotated 180 degrees from the treatment machine and the CT scan of your prostate will be performed. After the CT scan, which will take about 5-8 minutes, the couch will be rotated back to the original position.
A trans-abdominal ultrasound of your prostate will also be performed twice per week for the first two weeks and then once a week from then on while you are on study. The MD Anderson staff and researchers will analyze the changes in prostate movement during radiation therapy using the scanned CT images and ultrasound images and compare them with positional changes displayed by the fiducial-based system.
Targeting of your prostate on a daily basis will be performed using the fiducial-based system. This will involve performing a pair of x-rays before your treatment. A shift will be made if needed using the implanted prostate markers. The position of the seeds after the shift will be routinely verified with another pair of x-rays. After alignment has occurred, a radiation treatment will then be delivered.
This is an investigational study. The fiducial-based system is FDA-approved. A total of 20 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Scan | – | Procedure: Computed Tomography (CT) ScanCT Scan with Fiducial markers + external beam radiation therapy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants with prostate cancer that will be treated with external beam radiation therapy.
Key inclusion criteria (9 listed)
- Patients with pathologic diagnosis of prostate cancer.
- Patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.
- Patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.
- Patients must be able to tolerate frequent (e.g. three CT scans per week) CT scanning.
- Patients must be able to lie flat and still for the duration of the fiducial-based localization and CT scanning sessions.
Key exclusion criteria (8 listed)
- Patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.
- Patients with an estimated prostate volume of less than 20 cc.
- Patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.
- Patients who have had previous radiation therapy to the pelvis.
- Patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).
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 |
|---|---|---|
| Computed Tomography (CT) ScanCT scan of the prostate three times a week, just before the delivery of radiation. | Procedure or surgery | CT Scan |
Primary outcome
Patient Prostate Position Calculated using both fiducials and CT methods
Time frame: At time of treatment planning (time 0) and at 24 additional time points during the 8-week course of radiotherapy (3 times per week)
Prostate position determined by center of mass (COM) of prostate. COM calculated by planning system based on contours of prostate on each CT slice. Prostate position assessed as the mean position of the three implanted fiducial markers (MPIF), which is computed using software provided by the commercial fiducial system. These two points (COM and MPIF) expressed using same coordinate system, whose origin is positioned treatment isocenter. Difference between the two points (COM and MPIF) defines a vector in 3-dimensional space. The three dimensions correspond to the right-left (RL), anterior-posterior (AP), and superior-inferior (SI) directions.
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 24 Mar 2023.
- University of Texas MD Anderson Cancer CenterLink 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.
Seungtaek Choi, MD principal investigator
M.D. Anderson Cancer Center
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 M.D. Anderson Cancer Center 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 9 inclusion and 8 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 24 Mar 2023. 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?
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?
Patient Prostate Position Calculated using both fiducials and CT methods (time frame: At time of treatment planning (time 0) and at 24 additional time points during the 8-week course of radiotherapy (3 times per week)). 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 24 Mar 2023.