Home › Prostate Cancer › NCT03933670
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
Who can join
Ages 18 and older · Men
Full 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.
About the study
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.
What is being tested
- Hyperpolarized Carbon C 13 Pyruvate (drug)
- Magnetic Resonance Spectroscopic Imaging (procedure)
- MRI Ultrasound Fusion Guided Biopsy (procedure)
Sponsor: University of California, San Francisco · Participants: 60 · Started: Jul 18, 2018
Contact the study team
- Louise Magat · Phone: (415) 502-1822
Official record on ClinicalTrials.gov — NCT03933670
Locations in the U.S.
| California | University of California, San Francisco, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.