Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy (NCT00499421) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy
United States23 participantsStarted 2005-09-14
Plain-language 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. 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.
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. If patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Prostate Position Calculated using both fiducials and CT methods
Timeframe: At time of treatment planning (time 0) and at 24 additional time points during the 8-week course of radiotherapy (3 times per week)
. Patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.
Exclusion criteria
. 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.