Characterize Tumor Hypoxia by Magnetic Resonance Imaging

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03987568
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location
1
Arm
28.2
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Blood draws
  • Diagnostic Test: Magnetic resonance imaging (MRI)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
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
Actual Study Start Date :
Jul 10, 2019
Actual Primary Completion Date :
Nov 15, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Differences in Tumor Hypoxia Scores Between Subgroups [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth CarolinaUnited States27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gagan Deep, Ph.D, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03987568
Other Study ID Numbers:
  • IRB00059037
  • WFBCCC 03319
  • P30CA012197
  • NCI-2019-04690
First Posted:
Jun 17, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021