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

Study Overview
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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.

Official Title
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Hypoxia Assessment in Localized Prostate Cancer: A Companion Protocol to a Phase II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: blood-oxygen-level-dependent functional magnetic resonance imaging
* Procedure: dynamic contrast-enhanced magnetic resonance imaging
* Procedure: magnetic resonance spectroscopic imaging
* Procedure: tissue-oxygen-level-dependent functional magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood-oxygen-level-dependent functional magnetic resonance imaging|nan|
|Procedure: dynamic contrast-enhanced magnetic resonance imaging|nan|
|Procedure: magnetic resonance spectroscopic imaging|nan|
|Procedure: tissue-oxygen-level-dependent functional magnetic resonance imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of global hypoxia within the prostate as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI |  |  | 
| Tumor vasculature and metabolism within the prostate as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging |  |  | 
| Correlation of prostate and normal tissue hypoxia before treatment with clinical outcomes after treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer