Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hyperpolarized Carbon C 13 Pyruvate
- Magnetic Resonance Spectroscopic Imaging
- MRI Ultrasound Fusion Guided Biopsy
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
1University of California, San Francisco94143, San FranciscoCalifornia, United States
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
National Cancer Institute (NCI)
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Source ClinicalTrials.gov