A Phase 2 Study of Magnetic Resonance (MR) Imaging with Hyperpolarized Pyruvate (13C) in Patients with Prostate Cancer on Active Surveillance
This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.
• The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.
• For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study.
• 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.
• Absolute neutrophil count (ANC) \>= 1000 cells/microliter (uL).
• Hemoglobin \>= 9.0 gm/deciliter (dL).
• Platelets \>= 75,000 cells/uL.
• Estimated creatinine clearance\* \>= 50 milliliter (mL)/min by the Cockcroft Gault equation.
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if =\< 3 x ULN if known/suspected Gilbert's
• Aspartate aminotransferase (AST) =\< 1.5 x ULN.
• Alanine aminotransferase (ALT) =\< 1.5 x ULN.