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Characterize Tumor Hypoxia by Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT03987568
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Tumor Other: Blood draws Diagnostic Test: Magnetic resonance imaging (MRI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (MRI biospecimen collection)
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.
Other: Blood draws
Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.

Diagnostic Test: Magnetic resonance imaging (MRI)
At the beginning of study magnetic resonance imaging MRI will be completed.




Primary Outcome Measures :
  1. Differences in Tumor Hypoxia Scores Between Subgroups [ Time Frame: 30 days ]
    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.

  2. Number of Biomarkers Expressed [ Time Frame: 30 days ]
    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 :
  1. ExoHypoxic Concentrations in Plasma [ Time Frame: 30 days ]
    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.

  2. Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations [ Time Frame: 30 days ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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): NCT03987568


Contacts
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Contact: Jennifer Thomas, RN 336-716-5440 jethomas@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jennifer Thomas, RN         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gagan Dee[, Ph.D Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03987568     History of Changes
Other Study ID Numbers: IRB00059037
WFBCCC 03319 ( Other Identifier: Wake Forest Baptist Comprenhensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

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