Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment

Completed · Phase 1

Conditions studied: Prostate Cancer, Cancer

In brief

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.

Key facts

Study ID

NCT00061347

Run by

National Cancer Institute (NCI)

People needed

15

Starts

2003-05-23

Expected to finish

2018-04-19

Last updated by the study team

2018-04-23

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with contraindication to transrectal needle placement:
• Bleeding disorder;
• PT/PTT greater than 1.5.times the upper limit of normal;
• Platelets less than 50K;
• Artificial heart valve.
• Patients with contraindications to MRI:
• Patients weighing greater than 136 kg (weight limit for scanner table);
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implanted electronic devices.
• Patients with chronic inflammatory bowel disease.
• Patients with distant metastatic disease.
• Patients with a prior history of pelvic or prostate radiotherapy.
• Cognitively impaired patients who cannot give informed consent.
• Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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