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Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
This study has been completed.
Study NCT00032058   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2002   Last Updated: July 22, 2009   History of Changes

March 8, 2002
July 22, 2009
June 2003
June 2006   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00032058 on ClinicalTrials.gov Archive Site
 
 
 
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study

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.

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.

 
Interventional
Diagnostic, Open Label
Prostate Cancer
  • Procedure: magnetic resonance imaging
  • Procedure: magnetic resonance spectroscopic imaging
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
June 2006   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032058
 
CDR0000069254, ACRIN-6659
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Jeffrey Weinreb, MD Yale University
National Cancer Institute (NCI)
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP