Gadoxetate Sodium Enhanced MRI as a Biomarker for Aggressive Prostate Cancer

• Status: Unknown status
• Trial end date: 2021-01-02
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this research study is to test to see if Gadoxetate Sodium is a useful contrast agent for detecting prostate cancer during magnetic resonance imaging (MRI). Gadoxetate Sodium is an FDA approved contrast agent that is currently used to detect liver cancer. Gadoxetate Sodium shows promise in identifying more aggressive prostate cancers at earlier stages. The study will also test to see if specific genes are expressed in the left over tissue samples from previous prostate fusion biopsy. The investigators hypothesize that Gadoxetate Sodium-enhanced MRI can differentiate aggressive prostate cancer and predict its early recurrence.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati

Criteria

Inclusion Criteria:

• Subject is greater than or equal to 18 years old.

• Subjects with clinically localized OR advanced prostate cancer with biopsy confirmation and sufficient tissue available (obtained before Gadoxetate Sodium injection) for OATP1B3 expression.

• Subjects must have a prior MRI with gadolinium obtained as part of their standard of care for comparison available. This may have been obtained as part of an image guided biopsy.

• Serum creatinine within 3 weeks prior to Gadoxetate Sodium MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 60 ml/min/1.73m.

• 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 3 times institutional upper limit of normal

• Ability of subject to sign a written informed consent document.

Exclusion Criteria:

• Subjects that have received a prostatectomy

• Subjects with known hypersensitivity and allergy to gadolinium contrast agents

• Subjects with chronic kidney disease or acute kidney injury. Chronic Kidney disease is GFR<30. Acute kidney injury (AKI) is defined as an abrupt or rapid decline in renal filtration function and is screened by excluding patient's that have a GFR <60 within 3 weeks of their scan, as well as screening patients on the day of the scan for kidney disease and contraindications using the standard form based on the Updated ACR Screening Recommendations on Gadolinium Based MR Contrast Agents, Renal Disease Patients. Patients who show signs of renal disease from this form will be excluded from the study.

• Subjects with contraindications to MRI

• Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI