Characterize Tumor Hypoxia by Magnetic Resonance Imaging

Prostate Cancer Clinical Trial

Official title:

To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03987568
• Other study ID #: IRB00059037
• Secondary ID: WFBCCC 03319P30C
• Status: Withdrawn
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: November 15, 2021

Study information

• Verified date: December 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Prostate Cancer
• Prostate Tumor
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Tumor Hypoxia Scores Between Subgroups	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.	30 days
Primary	Number of Biomarkers Expressed	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.	30 days
Secondary	ExoHypoxic Concentrations in Plasma	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.	30 days
Secondary	Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations	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.	30 days