Clinical trial · Interventional
Characterize Tumor Hypoxia by Magnetic Resonance Imaging
To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Issues in reserving MRI scanner
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Tumor | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draws | Other | — | UNRESOLVED |
| Magnetic resonance imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (MRI biospecimen collection)
- 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.
- interventionNames
- Other: Blood draws
- Diagnostic Test: Magnetic resonance imaging (MRI)
Primary outcomes (2)
- measure
- Differences in Tumor Hypoxia Scores Between Subgroups
- timeFrame
- 30 days
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available