Hyperpolarized Pyruvate Injection in Subjects With Prostate Cancer

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Current imaging options do not assess prostate cancer well. This study will combine two magnetic resonance imaging modalities, MRI and MRSI, in order to determine the utility to physicians and patients with prostate cancer in making treatment decisions and seeing how well various types of treatment work. Hyperpolarized pyruvate (13C) is an investigational product that may enhance the imaging capability of MRI and MRSI. Hyperpolarized pyruvate will be injected into the body to determine how it is metabolized and how it's metabolism can be assessed using MR imaging.

The purpose of this study is to determine the safety and metabolism of hyperpolarized pyruvate in humans, and how this can be used to increase the effectiveness of MR imaging with regards to patient care.

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

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: GE Healthcare

Criteria

INCLUSION CRITERIA:

1. The subject has biopsy-proven prostate cancer and is either undergoing active surveillance ("watchful waiting") or pre primary local treatment for prostate cancer (i.e., prior to either radiation therapy or radical prostatectomy).

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

3. The subject has concordant MRI/1H MRSI findings from a prior MR staging exam performed within 8 weeks of the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam.

4. Negative test for hepatitis B and hepatitis C.

5. Eastern Cooperative Oncology Group Performance Status of 0 or 1.

6. Laboratory criteria for protocol entry:

• Absolute neutrophil count (ANC) >/= 1500 cells/microLiters

• Hemoglobin >/= 9.0 gm/dL

• Platelets >/= 100,000 cells/microLiters

• Estimated creatinine clearance >/= 60 mL/min (by the Cockcroft Gault equation)

• Bilirubin within normal range

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within normal range

7. Willing to use contraception during and for 1 month after completion of the study.

EXCLUSION CRITERIA:

1. The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study.

2. Current or prior androgen deprivation therapy; previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 1 month prior to study entry.

3. Poorly controlled hypertension, with blood pressure at study entry >150/90.

4. Contraindication for or inability to tolerate MRI examination.

5. Prostate biopsy within 12 weeks prior to study entry.

6. BMI of less than 18.5 or greater than 32. At the 0.43 ml/kg dose, subject body weight should be less than or equal to 100 kg owing to limitations in the amount of IMP available.

7. Congestive heart failure or New York Heart Association (NYHA) status >2.

8. A past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG.

9. Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year.