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Pilot Study of Eovist (Gadoxetate) Enhanced MRI for the Detection of Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Pilot Study of Eovist (Gadoxetate) Enhanced MRI for the Detection of Prostate Cancer


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, 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(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.

Primary Objective:

- Evaluate the uptake and retention of Eovist(Registered Trademark) in prostate cancers.

Eligibility:

- 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.

or

-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
expression.

Design:

- 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
disease

- Each subject will receive a single IV dose of Eovist(Registered Trademark) by bolus
injection

- All subjects will undergo MRI prior to and immediately after, 10, 20 and 60 minutes
post-Eovist(Registered Trademark) injection

Inclusion 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 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 CT or MRI scan)
available for OATP1B3 expression.

or

2.1.1.4 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
expression.

2.1.1.5 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 Gilbert's syndrome

- AST(SGOT) and ALT(SGPT) less than or equal to 2.5 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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Uptake of Eovist to evaluate MR contrast enhancements in prostate cancer

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ismail B Turkbey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

130145

NCT ID:

NCT01867424

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Prostate Cancer
  • Testosterone Membrane Transporter
  • OATP1B3
  • Castration Resistant Prostate Cancer
  • Prostatectomy
  • Gadolinium-Based Contrast Agent
  • Prostatic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892