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Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diffusion-weighted magnetic resonance imaging
laboratory biomarker analysis
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenocarcinoma of the Prostate

Eligibility Criteria

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

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • USC Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (diffusion-weighted MRI)

Arm Description

Patients undergo diffusion-weighted MRI of the pelvis.

Outcomes

Primary Outcome Measures

Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2014
Last Updated
September 9, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02237612
Brief Title
Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer
Official Title
Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 of the body. New imaging techniques, such as diffusion-weighted MRI, may be a less invasive way of predicting the stage and grade of prostate cancer.
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: Patients undergo diffusion-weighted MRI of the pelvis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (diffusion-weighted MRI)
Arm Type
Experimental
Arm Description
Patients undergo diffusion-weighted MRI of the pelvis.
Intervention Type
Procedure
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Undergo diffusion-weighted MRI
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of patients found to have extracapsular extension and seminal vesicle involvement using Diffusion-Weighted MRI
Description
Patients will be imaged using diffusion-weighted MR. Findings will be correlated with histopathologic findings at biopsy and/or prostatectomy.
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Dorff
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

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