MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00963300|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Not yet recruiting
First Posted : August 21, 2009
Last Update Posted : February 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||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||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||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|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2010|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963300
|Principal Investigator:||Robert D. Timmerman, MD||Simmons Cancer Center|