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

Study Overview
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Brief Summary
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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
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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.

Official Title
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MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: magnetic resonance imaging
* Procedure: magnetic resonance spectroscopic imaging


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage I-II adenocarcinoma of the prostate At least 6 weeks since prior biopsy Scheduled to undergo radical prostatectomy within 6 months of MRI and magnetic resonance spectroscopic imaging (MRSI) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No cardiac pacemakers Other: Must be willing and able to undergo MRI/MRSI No allergy to latex No contraindications to MRI such as non-compatible intracranial vascular clips No metallic hip implant or any other metallic implant or device that would compromise quality of MRI/MRSI No contraindications to or intolerance of endorectal coil insertion (e.g., prior abdominoperineal resection of the rectum or Crohn's disease) No general medical or psychiatric condition or physiologic status unrelated to prostate cancer that would preclude valid informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: No prior BCG for bladder cancer Chemotherapy: Not specified Endocrine therapy: No prior androgen-deprivation therapy Radiotherapy: No prior prostatic or rectal radiotherapy Surgery: See Disease Characteristics No prior cryosurgery No prior surgery for prostate cancer No prior transurethral resection of the prostate (TURP) No prior rectal surgery Other: No prior complementary alternative medicine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: magnetic resonance imaging|nan|
|Procedure: magnetic resonance spectroscopic imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer