MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy

NCT ID: NCT00963300

Last Updated: 2018-11-26

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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RATIONALE: Diagnostic procedures, such as MRI, may help measure oxygen levels in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying how well MRI works in assessing hypoxia in patients with localized prostate cancer undergoing stereotactic body radiation therapy.

Detailed Description

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OBJECTIVES:

* To characterize the status of global hypoxia within the prostate before stereotactic body radiotherapy (SBRT) as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI.
* To characterize tumor vasculature and metabolism within the prostate before SBRT as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging, respectively.
* Correlate prostate and normal tissue hypoxia before SBRT with clinical outcomes (toxicity and biochemical \[PSA\] control) after SBRT.

OUTLINE: Within 1-3 weeks before beginning stereotactic body radiotherapy, patients undergo T2-weighted anatomic MRI, magnetic resonance spectroscopic imaging, blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI, and dynamic contrast-enhanced MRI.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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blood-oxygen-level-dependent functional magnetic resonance imaging

Intervention Type PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type PROCEDURE

magnetic resonance spectroscopic imaging

Intervention Type PROCEDURE

tissue-oxygen-level-dependent functional magnetic resonance imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Biopsy proven adenocarcinoma of the prostate

* Localized disease
* Scheduled to undergo treatment with stereotactic body radiotherapy (SBRT) on a phase II clinical trial

* Has not yet started SBRT

PATIENT CHARACTERISTICS:

* Serum creatinine ≤ 1.2 mg/dL
* No claustrophobia
* No other contraindication to MRI (e.g., implanted pacemaker device)
* No known allergy to MRI contrast

PRIOR CONCURRENT THERAPY:

* No prior treatment for prostate cancer (e.g., hormonal therapy or chemotherapy)
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert D. Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Other Identifiers

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CDR0000652306

Identifier Type: REGISTRY

Identifier Source: secondary_id

SCCC-062009-014

Identifier Type: -

Identifier Source: org_study_id

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