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Characterize Tumor Hypoxia by Magnetic Resonance Imaging

Primary Purpose

Prostate Cancer, Prostate Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood draws
Magnetic resonance imaging (MRI)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The minimum age for this study is men 40 years and older. Prostate cancer mainly affects men over the age of 40.
  • Patients with Caucasian and African American race
  • Patients with pathology-proven prostate cancer (Gleason 6 or higher)
  • Patients who have not yet undergone therapy (systemic drugs, radiation, or prostatectomy)
  • Patients who will have a radical prostatectomy as standard of care.
  • Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

  • Patients who have already received some form of treatment or are not planning to undergo radical prostatectomy for treatment.
  • Patients with any other cancer along with prostate cancer.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (MRI biospecimen collection)

    Arm Description

    Patients undergo MRI over 15 minutes before standard of care surgery. Patients also undergo collection of blood samples during MRI and at the time of surgery.

    Outcomes

    Primary Outcome Measures

    Differences in Tumor Hypoxia Scores Between Subgroups
    Using MRI parameters including apparent diffusion coefficient and fractional blood value four race/score combination groups (African-Americans with Gleason score 6; African-Americans with Gleason score greater than or equal to 7; Caucasians with Gleason score 6; and Caucasian with Gleason score greater than or equal to 7) to calculate the correlation coefficients estimates between hypoxic scores using Pearson correlation coefficient and Spearman's rank correlation coefficient.
    Number of Biomarkers Expressed
    Expression of proliferation biomarkers (Ki-67 and PCNA) to calculate the correlation coefficients estimates between expression of proliferation biomarkers using Pearson correlation coefficient and Spearman's rank correlation coefficient.

    Secondary Outcome Measures

    ExoHypoxic Concentrations in Plasma
    The associations between hypoxic score and candidate biomarkers for ExoHypoxic concentration (number per milliliter plasma) will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.
    Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations
    The associations between hypoxic score and fatty acid synthase expression will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.

    Full Information

    First Posted
    June 13, 2019
    Last Updated
    December 19, 2022
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03987568
    Brief Title
    Characterize Tumor Hypoxia by Magnetic Resonance Imaging
    Official Title
    To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Issues in reserving MRI scanner
    Study Start Date
    July 10, 2019 (Actual)
    Primary Completion Date
    November 15, 2021 (Actual)
    Study Completion Date
    November 15, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this research study is to measure the hypoxia (low oxygen condition) in prostate cancers and its effect in survival. In this study, investigators will assess hypoxia by magnetic resonance imaging (MRI) and create a hypoxia score. Investigators will study the hypoxia score and how it correlates (if any) to the disease aggressiveness as well as its effect on the treatment outcomes.
    Detailed Description
    Primary Objective(s): To assess hypoxia in primary prostate tumors by magnetic resonance imaging. To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression). Secondary Objective(s): To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient. To correlate hypoxic score with fatty acid synthase (FASN) expression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Prostate Tumor

    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

    Arm Title
    Diagnostic (MRI biospecimen collection)
    Arm Type
    Experimental
    Arm Description
    Patients undergo MRI over 15 minutes before standard of care surgery. Patients also undergo collection of blood samples during MRI and at the time of surgery.
    Intervention Type
    Other
    Intervention Name(s)
    Blood draws
    Intervention Description
    Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Magnetic resonance imaging (MRI)
    Intervention Description
    At the beginning of study magnetic resonance imaging MRI will be completed.
    Primary Outcome Measure Information:
    Title
    Differences in Tumor Hypoxia Scores Between Subgroups
    Description
    Using MRI parameters including apparent diffusion coefficient and fractional blood value four race/score combination groups (African-Americans with Gleason score 6; African-Americans with Gleason score greater than or equal to 7; Caucasians with Gleason score 6; and Caucasian with Gleason score greater than or equal to 7) to calculate the correlation coefficients estimates between hypoxic scores using Pearson correlation coefficient and Spearman's rank correlation coefficient.
    Time Frame
    30 days
    Title
    Number of Biomarkers Expressed
    Description
    Expression of proliferation biomarkers (Ki-67 and PCNA) to calculate the correlation coefficients estimates between expression of proliferation biomarkers using Pearson correlation coefficient and Spearman's rank correlation coefficient.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    ExoHypoxic Concentrations in Plasma
    Description
    The associations between hypoxic score and candidate biomarkers for ExoHypoxic concentration (number per milliliter plasma) will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.
    Time Frame
    30 days
    Title
    Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations
    Description
    The associations between hypoxic score and fatty acid synthase expression will be estimated using partial Spearman's rank correlation coefficient where the race/score combination groups are adjusted.
    Time Frame
    30 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The minimum age for this study is men 40 years and older. Prostate cancer mainly affects men over the age of 40. Patients with Caucasian and African American race Patients with pathology-proven prostate cancer (Gleason 6 or higher) Patients who have not yet undergone therapy (systemic drugs, radiation, or prostatectomy) Patients who will have a radical prostatectomy as standard of care. Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: Patients who have already received some form of treatment or are not planning to undergo radical prostatectomy for treatment. Patients with any other cancer along with prostate cancer. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gagan Deep, Ph.D
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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