Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-25 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 12:00 AM
NCT ID: NCT00032058
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.
Study: NCT00032058
Study Brief:
Protocol Section: NCT00032058