Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy

NCT00499421 | Completed

• 1 other identifier: 2004-0428
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; External Beam Radiation Therapy; Fiducial Markers; Acculoc System; Center Of Mass; EBRT

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of treatment planning (time 0) and at 24 additional time points during the 8-week course of radiotherapy (3 times per week)

Study Arms (1)

CT Scan

CT Scan with Fiducial markers + external beam radiation therapy

Procedure: Computed Tomography (CT) Scan

Interventions

Computed Tomography (CT) Scan PROCEDURE

CT scan of the prostate three times a week, just before the delivery of radiation.

CT Scan

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants with prostate cancer that will be treated with external beam radiation therapy.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Seungtaek Choi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: September 14, 2005
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

US (1)