Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Eovist
Intervention description: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Testosterone Membrane Transporter; OATP1B3; Castration Resistant Prostate Cancer; Prostatectomy; Gadolinium-Based Contrast Agent

Summary:

      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.
    

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