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

This is a pilot study evaluating pre-surgical patients with histologically confirmed
localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection
and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical
prostatectomy. At least 20 patients will be required to have high risk disease as defined by
primary Gleason score of 4 or 5 on prior prostate biopsy.

Inclusion Criteria:

- Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of UCSF,
if detailed results of sextant biopsy are available. A minimum of 20 patients out of a
planned enrollment of 50 patients must have high-risk disease as defined by primary
Gleason score of 4 or 5 on prior prostate biopsy.

- Planned radical prostatectomy at University of California, San Francisco (UCSF) within
12 weeks following protocol MRI/magnetic resonance spectroscopic imaging (MRSI).

- The subject is able and willing to comply with study procedures and provide signed and
dated informed consent.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

- Adequate organ function, including absolute neutrophil count (ANC) ≥1500 cells/μL,
hemoglobin ≥9.0 gm/dL, platelets ≥75,000 cells/μL, estimated creatinine clearance ≥50
mL/min (by the Cockcroft Gault equation), bilirubin <1.5x upper limit of normal (ULN)
(unless Gilbert's is suspected), aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) <1.5x ULN.

- For patients with partners of childbearing potential, willing to use adequate
contraception for one month after undergoing hyperpolarized (HP) pyruvate infusion.

Exclusion Criteria:

- Patients who because of age less than 18 years old, general medical or psychiatric
condition, or physiologic status cannot give valid informed consent.

- Patients unwilling or unable to undergo MR imaging, including patients with
contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial
vascular clips.

- Patients who cannot tolerate or have contra-indications to endorectal coil insertion;
for example, patients with a prior abdominoperineal resection of the rectum or latex
allergy.

- Patients with contra-indications to injection of gadolinium contrast; for example
patients with prior documented allergy or those with inadequate renal function.

- Metallic hip implant or any other metallic implant or device that distorts local
magnetic field and compromises the quality of MR imaging.

- Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to
study enrollment. No limit on number of prior prostate biopsies. Prior transurethral
resection of the prostate (TURP) is not allowed.

- Current or prior androgen deprivation therapy. A history of use of a 5-α reductase
inhibitor is allowed, provided it was discontinued at least one month prior to study
entry.

- Poorly controlled hypertension, with blood pressure at study entry >160/100. The
addition of anti-hypertensives to control blood pressure is allowed for eligibility
determination.

- Congestive heart failure or New York Heart Association (NYHA) status ≥ 2.

- A history of clinically significant EKG abnormalities, including QT prolongation, a
family history of prolonged QT interval syndrome, or myocardial infarction (MI) within
6 months of study entry. Patients with rate-controlled atrial fibrillation/flutter
will be allowed on study.