Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

Not Applicable

Completed

• Conditions: Adenocarcinoma of the Prostate; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Interventions: Procedure: diffusion-weighted magnetic resonance imaging; Other: laboratory biomarker analysis

• Registration Number: NCT02237612
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Study First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (diffusion-weighted MRI)	diffusion-weighted magnetic resonance imaging	Patients undergo diffusion-weighted MRI of the pelvis.
Diagnostic (diffusion-weighted MRI)	laboratory biomarker analysis	Patients undergo diffusion-weighted MRI of the pelvis.

Primary Outcome Measures

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

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States