RecruitingPhase 2NCT03933670

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

A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance

Sponsor

University of California, San Francisco

Enrollment

60 participants

Start Date

Jul 18, 2018

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Prostate Adenocarcinoma

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria11

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 Criteria6

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.