Diffusion-Weighted MRI in Staging Patients With Localized Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (diffusion-weighted MRI)

Patients undergo diffusion-weighted MRI of the pelvis.

Group Type EXPERIMENTAL

diffusion-weighted magnetic resonance imaging

Intervention Type PROCEDURE

Undergo diffusion-weighted MRI

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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diffusion-weighted magnetic resonance imaging

Undergo diffusion-weighted MRI

Intervention Type PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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diffusion-weighted MRI

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No