Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Testosterone Membrane Transporter, OATP1B3, Castration Resistant Prostate Cancer, Prostatectomy, Gadolinium-Based Contrast Agent
Eligibility Criteria
- INCLUSION CRITERIA:
2.1.1.1 Subject is greater than or equal to 18 years old.
2.1.1.2 Subjects with clinically localized prostate cancer (outside pathology is acceptable) must have image guided biopsy confirmed prostate cancer and sufficient tissue available (obtained before or after 20 weeks of Eovist injection) for organic anion-transporting polypeptide 1B3 (OATP1B3) expression.
2.1.1.3 Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue (obtained before or after 20 weeks of Eovist injection) from a soft tissue lesion (measuring greater than or equal to 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for OATP1B3 expression.
or
2.1.1.4 Subjects, for whom tissue is not available, must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
2.1.1.5 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
2.1.1.6 Serum creatinine within 3 weeks prior to Eovist MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 30 ml/min/1.73m(2).
2.1.1.7 Patients must have normal liver function as defined below:
- total bilirubin less than 2 times normal institutional limits or greater than 3.0 mg/dl in patients with Gilberts syndrome
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times institutional upper limit of normal
2.1.1.8 Ability of subject to sign a written informed consent document
EXCLUSION CRITERIA:
2.1.2.1 Subjects with known hypersensitivity and allergy to gadolinium contrast agents
2.1.2.2 Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
2.1.2.3 Subjects with severe claustrophobia unresponsive to oral anxiolytics
2.1.2.4 Subjects with contraindications to magnetic resonance imaging (MRI)
2.1.2.5 Subjects weighing greater than 136 kg (weight limit for scanner table)
2.1.2.6 Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
2.1.2.7 Subjects with other medical conditions deemed by the principle investigator (or associates) to make the subject ineligible for protocol procedures
2.1.2.8 Subjects who will have a delay in clinically indicated radiation therapy due to the interval between Eovist MRI imaging and biopsy
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Participants with Advanced Disease
Participants with Localized Disease
Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.