Pilot Study of Eovist (Gadoxetate) Enhanced MRI for the Detection of Prostate Cancer
- 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
- The expression of a testosterone membrane transporter, 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
- Current imaging methods cannot predict treatment failure or resistance.
- Gadoxetate disodium (Gd-EOB-DTPA) (Eovist(Registered Trademark), 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 do not. However, those HCC's that
do take up Eovist(Registered Trademark) have been shown to express OATP1B3.
- Eovist(Registered Trademark) may be useful to evaluate OATP1B3 status in patients with
prostate cancer and may therefore serve as a prognostic and treatment biomarker.
- Evaluate the uptake and retention of Eovist(Registered Trademark) in prostate cancers.
- Male subjects greater than or equal to 18 years old
- 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 IHC.
- Subjects with advanced disease who have failed hormone therapy and who have sufficient
tissue from a soft tissue lesion (measuring greater than or equal to 1.5cm in diameter
at CT or MRI scan) available for OATP1B3 IHC.
-Subjects, for whom tissue is not available, must have a soft tissue lesion that can be
biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3
- This pilot study will accrue 20 subjects divided into two arms: 10 evaluable subjects
with localized prostate cancer and 10 evaluable subjects with advanced soft tissue
- Each subject will receive a single IV dose of Eovist(Registered Trademark) by bolus
- All subjects will undergo MRI prior to and immediately after, 10, 20 and 60 minutes
post-Eovist(Registered Trademark) injection
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Uptake of Eovist to evaluate MR contrast enhancements in prostate cancer
Ismail B Turkbey, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|