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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032058
• Other study ID #: CDR0000069254
• Secondary ID: ACRIN-6659
• Status: Completed
• Phase: N/A
• First received: March 8, 2002
• Last updated: February 18, 2011
• Start date: June 2003

Study information

• Verified date: April 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• magnetic resonance imaging

• magnetic resonance spectroscopic imaging

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
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	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,