Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      BACKGROUND:

        -  Prostate cancer is the most common non-cutaneous malignancy among men in the western
           world. Prognostic biomarkers would be useful in stratifying patients to different
           treatments.

        -  The expression of a testosterone membrane transporter, organic anion-transporting
           polypeptide 1B3 (OATP1B3), is associated with shorter time to progression after hormonal
           ablation therapy and shorter overall survival in prostate cancer patients. 52% of
           localized prostate cancer lesions express OATP1B3, while 92% of prostate cancer
           metastases requiring hormonal ablation treatment, express OATP1B3 in soft tissue
           lesions. Expression of OATP1B3 also correlates with Gleason grade.

        -  Current imaging methods cannot predict treatment failure or resistance.

        -  Gadoxetate disodium (Gd-EOB-DTPA) (Eovist , Bayer HealthCare Pharmaceuticals Inc.
           Pittsburgh, PA) is an MR imaging agent which is FDA-approved gadolinium chelate for
           detecting hepatocellular carcinoma (HCC), as normal hepatocytes express OATP1B3 while
           most hepatocellular carcinomas (HCC) do not. However, those HCCs that do take up Eovist
           have been shown to express OATP1B3.

        -  Eovist may be useful to evaluate OATP1B3 status in patients with prostate cancer and may
           therefore serve as a prognostic and treatment biomarker.

      PRIMARY OBJECTIVE:

      -Evaluate the uptake and retention of Eovist in prostate cancers.

      ELIGIBILTY:

        -  Male subjects greater than or equal to 18 years old

        -  Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2

        -  Subjects with clinically localized prostate cancer must have image guided biopsy
           confirmed prostate cancer and sufficient tissue available for OATP1B3
           immunohistochemistry (IHC).

        -  Subjects with advanced disease who have failed hormone therapy and who have sufficient
           tissue from a soft tissue or metastatic bone lesion (measuring greater than or equal
           to1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI)
           scan) available for OATP1B3 IHC.

      or

      -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.

      DESIGN:

        -  This pilot study will accrue 25 subjects divided into two arms: 10 evaluable subjects
           with localized prostate cancer and 15 evaluable subjects with advanced disease

        -  Each subject will receive a single intravenous (IV) dose of Eovist by bolus injection

        -  All subjects will undergo magnetic resonance imaging (MRI) prior to and immediately
           after, 10, 20 and 60 minutes post-Eovist injection
    

Intervention name(s): Eovist
Intervention type(s): Drug
Intervention description(s): 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Testosterone Membrane Transporter; OATP1B3; Castration Resistant Prostate Cancer; Prostatectomy; Gadolinium-Based Contrast Agent