NCT03933670 · University of California, San Francisco
Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Hyperpolarized Carbon C 13 Pyruvate
Given IV
PROCEDURE
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
PROCEDURE
MRI Ultrasound Fusion Guided Biopsy
Undergo MR/US fusion-guided prostate biopsy
Primary outcome measures
Signal-to-noise ratio (SNR) of hyperpolarized lactate
Time frame: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics.
Intra-tumoral C-pyruvate to lactate (kPL)
Time frame: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
Intra-tumoral C-pyruvate to glutamate (kPG)
Time frame: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade
Time frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam
kPL will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPL will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade
Time frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam
kPG will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPG will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Francisco, California
Collaborators
National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations