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

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood-oxygen-level-dependent functional magnetic resonance imaging
dynamic contrast-enhanced magnetic resonance imaging
magnetic resonance spectroscopic imaging
tissue-oxygen-level-dependent functional magnetic resonance imaging
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

    Outcomes

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2009
    Last Updated
    November 21, 2018
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00963300
    Brief Title
    MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Project Never Initiated - no human subjects were enrolled and no data regarding humans was collected or studied
    Study Start Date
    September 2009 (Anticipated)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    blood-oxygen-level-dependent functional magnetic resonance imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    dynamic contrast-enhanced magnetic resonance imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    magnetic resonance spectroscopic imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    tissue-oxygen-level-dependent functional magnetic resonance imaging
    Primary Outcome Measure Information:
    Title
    Status of global hypoxia within the prostate as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI
    Title
    Tumor vasculature and metabolism within the prostate as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging
    Title
    Correlation of prostate and normal tissue hypoxia before treatment with clinical outcomes after treatment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert D. Timmerman, MD
    Organizational Affiliation
    Simmons Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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