Status:
COMPLETED
Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Stage IIA Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (MRI) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts o...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the sensitivity and specificity of diffusion-weighted MRI for pathologic T3 stage prostate cancer using a 3 Tesla (3T) magnet with a surface coil. OUTLINE: Patie...
Eligibility Criteria
Inclusion
- Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:
- Gleason \>= 7
- \> 50% biopsy cores +
- Prostate-specific antigen (PSA) \>= 10
- Interested in undergoing a radical prostatectomy as definitive management for prostate cancer
- No clinical or radiographic evidence for distant metastatic disease
- In subjects with PSA \< 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA \> 20, a bone scan must document lack of concern for bone involvement
Exclusion
- Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor
- History of claustrophobia
- Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria
- Unable to give written informed consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02237612
Start Date
January 1 2009
End Date
March 1 2013
Last Update
September 11 2014
Active Locations (1)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033