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Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer

Not Applicable
Completed
Conditions
Prostate Cancer
Registration Number
NCT00032058
Lead Sponsor
American College of Radiology Imaging Network
Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

🇺🇸

Baltimore, Maryland, United States

UCSF Comprehensive Cancer Center

🇺🇸

San Francisco, California, United States

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

🇺🇸

Rochester, Minnesota, United States

Yale Comprehensive Cancer Center

🇺🇸

New Haven, Connecticut, United States

Abramson Cancer Center of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

M.D. Anderson Cancer Center at University of Texas

🇺🇸

Houston, Texas, United States

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