Characterize Tumor Hypoxia by Magnetic Resonance Imaging

Not Applicable

Withdrawn

• Conditions: Prostate Tumor; Prostate Cancer
• Interventions: Other: Blood draws; Diagnostic Test: Magnetic resonance imaging (MRI)

• Registration Number: NCT03987568
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Study Start: 2019-07-10
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRI biospecimen collection)	Magnetic resonance imaging (MRI)	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.
Diagnostic (MRI biospecimen collection)	Blood draws	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.