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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00963300
First Posted: August 21, 2009
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Simmons Cancer Center
Investigators
Principal Investigator: Robert D. Timmerman, MD Simmons Cancer Center
  More Information

Responsible Party: Robert Dale Timmerman, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
ClinicalTrials.gov Identifier: NCT00963300     History of Changes
Other Study ID Numbers: CDR0000652306
SCCC-062009-014
First Submitted: August 20, 2009
First Posted: August 21, 2009
Last Update Posted: February 21, 2011
Last Verified: August 2009

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Hypoxia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms