Magnetic Resonance Spectroscopic Imaging with Hyperpolarized Carbon C 13 Pyruvate in Finding High-Grade Localized Prostate Cancer in Patients Undergoing Radical Prostatectomy or Who Have Undergone High Intensity Focused Ultrasound Focal Therapy

PRIMARY OBJECTIVES:

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. (Cohort A [Pre-RP])

II. To investigate the association between HP pyruvate-to-lactate conversion (kPL) and HP urea perfusion with in-field clinically significant (Gleason score > 3+3) recurrent/residual prostate cancer following HIFU focal therapy. (Cohort B [Post-HIFU])

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. (Cohort A only)

III. To determine the optimal cut-off value of peak lac/pyr, lac/pyr AUC, kPL Urea AUC, urea ktrans and kUP on MRI that accurately detects in-field clinically significant (ie. Gleason score > 3+3) recurrent/residual prostate cancer. (Cohort B only)

IV. 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.

V. 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 undergoing RP are assigned to cohort A, patients who have undergone HIFU and MR targeted biopsy are assigned to cohort B.

COHORT A: Patients receive hyperpolarized carbon C 13 pyruvate and/or co-polarized carbon C 13/nitrogen N 15-labeled urea intravenously (IV) and undergo MRSI within 12 weeks before undergoing RP. Patients may receive optional second hyperpolarized carbon C 13 pyruvate injection and undergo MRSI within 15-60 minutes after first scan. Patients undergo blood sample collection throughout the study.

COHORT B: Patients receive hyperpolarized carbon C 13 pyruvate and/or co-polarized carbon C 13/nitrogen N 15-labeled urea IV and undergo MRSI within 12 weeks before undergoing MR targeted biopsy. Patients may receive optional second hyperpolarized carbon C 13 pyruvate injection and undergo MRSI within 15-60 minutes after first scan. Patients undergo blood sample collection throughout the study.

After completion of study, patients are followed up at 24 hours.