A Pilot Study of Magnetic Resonance (MR) Imaging with Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer
This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue
• Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of University of California, San Francisco (UCSF), if detailed results of sextant biopsy are available. For Cohort A only, a minimum of 20 participants 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.
• Cohort A only: Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI.
• Cohort B only: HIFU focal therapy completed within 18 months of protocol MRI/MRSI, and planned systematic and MR-guided biopsy at UCSF within 12 weeks following protocol MRI/MRSI.
• The participant 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
• Absolute neutrophil count (ANC) \>= 1500 cells/microliter (uL)
• Hemoglobin \>= 9.0 mg/dL
• Platelets \>= 75,000 cells/uL
• Estimated creatinine clearance \>= 50 mL/min (by the Cockcroft Gault equation)
• Bilirubin \< 1.5 x upper limit of normal (ULN) (unless Gilbert's is suspected)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 x ULN