Characterize Tumor Hypoxia by Magnetic Resonance Imaging

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Prostate Tumor; Prostate Cancer

Treatments: Other: Blood draws; Diagnostic Test: Magnetic resonance imaging (MRI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03987568

P30CA012197 (U.S. NIH Grant/Contract)

IRB00059037

NCI-2019-04690 (Other Identifier)

WFBCCC 03319 (Other Identifier)

Details and patient eligibility

About

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.

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.

Sex: Male

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Diagnostic (MRI biospecimen collection)

Experimental group

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.

Treatment:

Other: Blood draws

Diagnostic Test: Magnetic resonance imaging (MRI)