Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance

Summary

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.

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
* Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
* Prior radiation treatment of the prostate.
* Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
* Poorly controlled hypertension, with blood pressure at study entry \> 160 mm Hg systolic or \> 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
* Congestive heart failure with New York Heart Association (NYHA) status \>= 2.

Conditions3

Locations1 site

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