Using advanced MRI to study prostate cancer metabolism
Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer
This study is testing a special type of MRI to see if it can safely help men aged 40 to 80 with suspected prostate cancer better understand the cancer's metabolism before they have a biopsy or surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04698564 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the safety and feasibility of using hyperpolarized 13C-pyruvate metabolic magnetic resonance imaging (MRI) in men suspected of having prostate cancer. The study will involve metabolic MRI without randomization or placebo treatment to assess the metabolic activity associated with prostate cancer. Participants will be men aged 40 to 80 who are planning to undergo MRI-targeted biopsy or radical prostatectomy. The goal is to gather insights into the metabolic processes of prostate cancer, which may enhance diagnostic capabilities.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 80 with clinical suspicion of prostate cancer, indicated by elevated PSA levels or abnormal DRE exams.
Not a fit: Patients who cannot undergo MRI scans or receive IV contrast will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved diagnostic accuracy and treatment planning for prostate cancer patients.
How similar studies have performed: While metabolic MRI is a novel approach in this context, similar imaging techniques have shown promise in other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age greater than 40 and less than 80 years 2. Clinical suspicion or history of prostate cancer reflected by one of the following: * PSA \> 4ng/ml * Abnormal DRE exam * Known tissue diagnosis of prostate cancer from prior workup 3. Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment Exclusion Criteria: 1. Inability to undergo MRI scan 2. Inability to receive IV contrast as per institutional protocol.
Where this trial is running
Baltimore, Maryland
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Minhaj Siddiqui, MD
- Email: msiddiqui@som.umaryland.edu
- Phone: 617-939-4823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.