Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study
Abstract
To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles.
Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy.
Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.
Conditions: Prostate Cancer, Cancer.
Primary outcome: To test the hypothesis that MRI guidance allows for accurate fiducial marker placement within the prostate; To determine the toxicity of MR-Guided fiducial marker placement.
Enrollment:…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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