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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnetic resonance imaging
magnetic resonance spectroscopic imaging
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center
  • Yale Comprehensive Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Brigham and Women's Hospital
  • Mayo Clinic Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania
  • M.D. Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
February 18, 2011
Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00032058
Brief Title
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
Official Title
MR Imaging And MR Spectroscopic Imaging Of Prostate Cancer Prior To Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Weinreb, MD
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0628
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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

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