Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer

Summary

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PRIMARY OBJECTIVE: I. To investigate the association between hyperpolarized (HP) pyruvate-to-lactate conversion (kPL) and HP urea perfusion with histologic grade of prostate cancer, including benign prostate tissue, low grade disease (primary Gleason score < 4), and high grade (primary Gleason score...

PRIMARY OBJECTIVE: I. To investigate the association between hyperpolarized (HP) pyruvate-to-lactate conversion (kPL) and HP urea perfusion with histologic grade of prostate cancer, including benign prostate tissue, low grade disease (primary Gleason score < 4), and high grade (primary Gleason score >= 4) prostate cancer. SECONDARY OBJECTIVES: I. Safety. II. To determine the optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr), lac/pyr area under the curve (AUC), 13C pyruvate to lactate (kPL) rate, urea AUC, and urea transfer constant (ktrans) on magnetic resonance imaging (MRI) that accurately detects primary Gleason 4 component cancer. III. To determine the reproducibility of peak lac/pyr, lac/pyr AUC and kPL, urea AUC and urea ktrans with same-day repeated dose studies. with same-day repeated dose studies. IV. To compare peak lac/pyr, lac/pyr AUC and kPL, urea AUC, urea ktrans on MRI with Prostate Imaging-Reporting and Data System (PI-RADS) assessment of multiparametic MRI in predicting regions of cancer versus benign tissue. EXPLORATORY OBJECTIVES: I. To correlate histologic markers, including lactate dehydrogenase A (LDHA) expression and activity level, along with Ki-67, MYC, and MCT 1 and 4 expression, with peak intra-tumoral lac/pyr ratio, lactate AUC, and kPL detected using anatomically aligned magnetic resonance (MR) cross-sectional images of the prostate gland. II. To test for an association between mean intra-tumoral lac/pyr signal and lactate AUC, kPL, urea AUC, and urea ktrans with adverse clinical and pathologic characteristics including extracapsular extension, positive nodal involvement, and failure to achieve undetectable prostate specific antigen (PSA) nadir following prostatectomy. OUTLINE: Patients receive hyperpolarized carbon C 13 pyruvate and urea C-13 intravenously (IV) and undergo MRSI within 12 weeks before undergoing radical prostatectomy. Patients may receive optional second hyperpolarized carbon C 13 pyruvate injection and undergo MRSI within 15-60 minutes after first scan. After completion of study, patients are followed up at 24 hours.

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