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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Apr 26, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to monitor prostate cancer in men who are not currently receiving treatment but are being watched closely, a process known as active surveillance. The study is testing a special type of MRI called hyperpolarized carbon C-13 pyruvate (HP C-13 pyruvate) MRI, which could help doctors see how cancer cells in the prostate are using and breaking down a specific substance. This information may help doctors better understand how the cancer is behaving over time.

To participate in this trial, you need to be a man between the ages of 65 and 74 with a confirmed diagnosis of low to intermediate risk prostate cancer. You should also be currently on active surveillance or planning to start it soon. Participants will undergo the HP C-13 pyruvate MRI and may have additional tests, like a prostate biopsy, within a few weeks after the initial scan. If you join the study, you’ll be helping researchers learn more about this imaging technique and its potential benefits for monitoring prostate cancer.

Gender

MALE

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