Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
RATIONALE: Imaging procedures such as magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) may improve the ability to detect the extent of prostate cancer. It is not yet known if MRI combined with MRSI is more effective than MRI alone in detecting the extent of prostate cancer.
PURPOSE: Diagnostic trial to compare the effectiveness of combining MRI with MRSI to that of MRI alone in determining the extent of prostate cancer in patients who are scheduled to undergo surgery to remove the prostate gland.
Procedure: magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study|
|Study Start Date:||June 2003|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
- Compare the accuracy of MRI vs MRI combined with magnetic resonance spectroscopic imaging (MRSI) for the localization of prostate cancer prior to radical prostatectomy in patients with stage I or II adenocarcinoma of the prostate.
- Compare the incremental benefit of these tests on diagnostic accuracy in these patients.
- Compare the incremental benefit of MRSI for interobserver agreement vs MRI alone in the localization of prostate cancer in these patients.
- Compare the accuracy of combined MRSI with that of other available information on tumor extent derived from digital rectal exam, PSA level, Gleason score, and Partin nomogram in these patients.
OUTLINE: This is a multicenter study.
At least 6 weeks after biopsy, patients undergo MRI and magnetic resonance spectroscopic imaging (MRSI) over approximately 1 hour. Within 6 months of MRI/MRSI, patients undergo radical prostatectomy.
PROJECTED ACCRUAL: A total of 134 patients will be accrued for this study within 7 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032058
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94143-0628|
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Jeffrey Weinreb, MD||Yale University|