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

NCT ID: NCT00032058

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

magnetic resonance imaging

Intervention Type: PROCEDURE

magnetic resonance spectroscopic imaging

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

American College of Radiology Imaging Network

NETWORK

Sponsor Role: lead

Principal Investigators

Jeffrey Weinreb, MD

Role: STUDY_CHAIR

Yale University

Locations

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

Other Identifiers

ACRIN-6659

Identifier Type: -

Identifier Source: secondary_id

CDR0000069254

Identifier Type: -

Identifier Source: org_study_id