Characterize Tumor Hypoxia by Magnetic Resonance Imaging

NCT03987568 | Withdrawn DMC FDA Device

• 4 other identifiers: IRB00059037WFBCCC 03319P30CA012197NCI-2019-04690
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer; Prostate Tumor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• ExoHypoxic Concentrations in Plasma

  30 days

• Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations

  30 days

Study Arms (1)

Diagnostic (MRI biospecimen collection)

EXPERIMENTAL

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.

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

Interventions

Blood draws OTHER

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

Diagnostic (MRI biospecimen collection)

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

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

Diagnostic (MRI biospecimen collection)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging

Study Officials

• Gagan Deep, Ph.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: July 10, 2019
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share