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 groupSponsors 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