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Characterize Tumor Hypoxia by Magnetic Resonance Imaging

NCT ID: NCT03987568

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2021-11-15

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Prostate Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Blood draws

Intervention Type OTHER

Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.

Magnetic resonance imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

At the beginning of study magnetic resonance imaging MRI will be completed.

Interventions

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Blood draws

Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.

Intervention Type OTHER

Magnetic resonance imaging (MRI)

At the beginning of study magnetic resonance imaging MRI will be completed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gagan Deep, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Countries

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United States

Other Identifiers

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WFBCCC 03319

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2019-04690

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00059037

Identifier Type: -

Identifier Source: org_study_id