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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00032058
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Not Applicable

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Masking: None (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
Actual Primary Completion Date : June 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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)



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No cardiac pacemakers


  • 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


Biologic therapy:

  • No prior BCG for bladder cancer


  • Not specified

Endocrine therapy:

  • No prior androgen-deprivation therapy


  • No prior prostatic or rectal radiotherapy


  • See Disease Characteristics
  • No prior cryosurgery
  • No prior surgery for prostate cancer
  • No prior transurethral resection of the prostate (TURP)
  • No prior rectal surgery


  • No prior complementary alternative medicine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Jeffrey Weinreb, MD Yale University Identifier: NCT00032058     History of Changes
Other Study ID Numbers: CDR0000069254
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: April 2005

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases