Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

September 9, 2014 updated by: University of Southern California

Diffusion-Weighted MRI for Staging in Localized Prostate Cancer: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (diffusion-weighted MRI)
Patients undergo diffusion-weighted MRI of the pelvis.
Other: laboratory biomarker analysis
Correlative studies
Procedure: diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Names:
  • diffusion-weighted MRI

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Tanya Dorff, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4P-08-4 (Other Identifier: USC Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2014-01848 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • HS-08-00413-CR004
  • HS-08-00413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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