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	Treatment or Intervention
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer	Procedure: diagnostic test  Procedure: magnetic resonance imaging  Procedure: magnetic resonance spectroscopic imaging

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143-0628,  United States; Recruiting
Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520,  United States; Recruiting
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States; Recruiting
Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting

Study chairs or principal investigators

Jeffrey Weinreb, MD,  Study Chair,  Yale University   

Study ID Numbers:  CDR0000069254; ACRIN-6659; NCT00032058
Record last reviewed:  December 2003
Last Updated:  March 28, 2005
Record first received:  March 8, 2002
ClinicalTrials.gov Identifier:  NCT00032058
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08