Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

Background: \- Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast agent used to help identify damaged liver tissue, can help tell these types of prostate cancer apart. It may be able to identify if a man has a type of prostate cancer for which hormone therapy may not work as well. Objectives: \- To see if gadoxetate can help identify different types of prostate cancers during imaging studies. Eligibility: \- Men at least 18 years of age who have prostate cancer. Participants will be having surgery to either remove the prostate or take tumor tissue samples. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. * Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They will receive gadoxetate during the MRI scan. * Participants who have surgery will have a sample of their tumor cells collected. Those who have a biopsy will provide cells from this biopsy for study. * Treatment will not be provided as part of this study.

Key facts

Study ID

NCT01867424

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2013-05-14

Expected to finish

2016-12-08

Last updated by the study team

2020-07-08

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• 1.2.1 Subjects with known hypersensitivity and allergy to gadolinium contrast agents
• 1.2.2 Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
• 1.2.3 Subjects with severe claustrophobia unresponsive to oral anxiolytics
• 1.2.4 Subjects with contraindications to magnetic resonance imaging (MRI)
• 1.2.5 Subjects weighing greater than 136 kg (weight limit for scanner table)
• 1.2.6 Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
• 1.2.7 Subjects with other medical conditions deemed by the principle investigator (or associates) to make the subject ineligible for protocol procedures
• 1.2.8 Subjects who will have a delay in clinically indicated radiation therapy due to the interval between Eovist MRI imaging and biopsy

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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