Prostate Cancer Clinical Trial

Characterize Tumor Hypoxia by Magnetic Resonance Imaging

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.

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Full 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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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.

Study is for people with:

Prostate Cancer

Study ID:

NCT03987568

Recruitment Status:

Withdrawn

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Study ID:

NCT03987568

Recruitment Status:

Withdrawn

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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