Protocol Details

Trans-Rectal Placement of Prostatic Fiducial Markers under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	03-C-0190
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male Min Age: 18 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Female; Children
Special Instructions	Currently Not Provided
Keywords	Prostate Cancer; Radiation Therapy; MRI; Fiducial Marker
Recruitment Keyword(s)	Prostate Cancer
Condition(s)	Prostatic Neoplasms
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	Drug: Levofloxacin Procedure/Surgery: MRI
Supporting Site	National Cancer Institute

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.

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Eligibility

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

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Citations:

Yu KK, Hricak H. Imaging prostate cancer. Radiol Clin North Am. 2000 Jan;38(1):59-85, viii.

Knopp MV, Weiss E, Sinn HP, Mattern J, Junkermann H, Radeleff J, Magener A, Brix G, Delorme S, Zuna I, van Kaick G. Pathophysiologic basis of contrast enhancement in breast tumors. J Magn Reson Imaging. 1999 Sep;10(3):260-6.

Kurhanewicz J, Vigneron DB, Hricak H, Narayan P, Carroll P, Nelson SJ. Three-dimensional H-1 MR spectroscopic imaging of the in situ human prostate with high (0.24-0.7-cm3) spatial resolution. Radiology. 1996 Mar;198(3):795-805.

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Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Kevin A. Camphausen, M.D. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 3-3940 10 Center Drive Bethesda, Maryland 20892 (301) 496-4164 kebebewe@mail.nih.gov	Sharon L. Smith, R.N. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 4-3740 10 Center Drive Bethesda, Maryland 20892 (301) 402-4395 gesuwank2@mail.nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937

Clinical Trials Number:

NCT00061347

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