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

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI); National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Criteria

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

• Contraindication to or inability to tolerate MRI with endorectal coil (e.g. severe claustrophobia, presence of cardiac pacemaker, aneurysm clip, severe or painful hemorrhoids, rectal stricture)

• Congestive heart failure with New York Heart Association (NYHA) status >= 2