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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00963300
First received: August 20, 2009
Last updated: February 18, 2011
Last verified: August 2009
  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 [ Designated as safety issue: No ]
  • Tumor vasculature and metabolism within the prostate as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging [ Designated as safety issue: No ]
  • Correlation of prostate and normal tissue hypoxia before treatment with clinical outcomes after treatment [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00963300

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

Additional Information:
No publications provided

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
Study First Received: August 20, 2009
Last Updated: February 18, 2011
Health Authority: Unspecified

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
Anoxia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014