NCT06391034 · Robert Bok, MD, PhD
Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
What this study is about
This is a Phase 2 clinical study of hyperpolarized (HP) 13C-pyruvate (13C), 15N-urea (13C,15N) metabolic MR imaging in prostate cancer patients who are undergoing or have received radiation therapy for prostate cancer.
View original scientific description
This is a Phase 2 clinical study of hyperpolarized (HP) 13C-pyruvate (13C), 15N-urea (13C,15N) metabolic MR imaging in prostate cancer patients who are undergoing or have received radiation therapy for prostate cancer.
Interventions
DRUG
hyperpolarized pyruvate +/-urea (13C/15N)
Given IV
RADIATION
Non-investigational External beam radiotherapy (EBRT)
External beam radiotherapy given outside of this study
PROCEDURE
Radiotherapy (RT)
Radiation therapy given outside of this study
PROCEDURE
Multi-parametric magnetic resonance imaging (mpMRI)
Imaging scan
BIOLOGICAL
Non-interventional hormone therapy
Therapy given outside of this study as part of standard of care
PROCEDURE
Prostate Biopsy
Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion
Primary outcome measures
Signal-to-noise ratio (Part 1)
Time frame: Day of MR imaging (1 day)
A signal-to-noise ratio is defined as a MR/spectroscopy parameter, consisting of the HP C13-Pyruvate or Lactate signal (peak) relative to background noise level (baseline) in MRI spectra of the tissue.
Mean HP 13C-pyruvate to lactate metabolic rate of conversion (kPL) over time (Part 2A)
Time frame: Up to 24 months
The mean percent change in tumoral kPL between baseline and 1-year post-EBRT will be reported.
Mean HP 13C-pyruvate to glutamate metabolic rate of conversion (kPG) over time (Part 2A)
Time frame: Up to 24 months
The mean percent change in tumoral kPG between baseline and 1-year post-EBRT will be reported.
Mean change in on-treatment kPL over time (Part 2B)
Time frame: Up to 24 months
Mean percent change in tumoral kPL for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported.
Mean change in on-treatment kPG over time (Part 2B)
Time frame: Up to 24 months
Mean percent change in tumoral kPG for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported.
Mean kPL at time of biochemical failure (Part 3)
Time frame: Up to 24 months
The mean kPL for participants with biochemical failure will be reported.
Mean kPG at time of biochemical failure (Part 3)
Time frame: Up to 24 months
The mean kPG for participants with biochemical failure will be reported.
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
- Participants must have biopsy-proven adenocarcinoma of the prostate, as determined by medical chart review.
- Part 1: Participants post-radiation therapy or currently considering EBRT.
- Part 2A: Participants currently scheduled for or considering EBRT (no neo-adjuvant therapy planned).
- Part 2B: Participants currently scheduled for or considering EBRT and neo-adjuvant therapy is planned. The participant has biopsy-proven adenocarcinoma of the prostate with high-risk disease, defined by the presence of at least two of following criteria: a tumor stage of T3 or T4, a Gleason score of 8 to 10, or a PSA level ≥40 ng/mL) and the participant must be planning to receive androgen deprivation therapy (ADT) with an Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist. The addition of an androgen-receptor (AR) signaling inhibitor (e.g., abiraterone, bicalutamide,apalutamide, enzalutamide or darolutamide) will be allowed.
- Part 3: Participants who have previously received radiation treatment to the prostate and are exhibiting signs of biochemical failure, with planned fusion biopsy within 12 weeks following completion of baseline HP 13C pyruvate +/-urea mpMRI.
- Participant is able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status \<= 1.
- Age \>= 18 years old at time of study entry.
- Ability to understand and the willingness to sign a written informed consent document.
- Demonstrates adequate organ function as defined below:
- White Blood Cell count (WBC) \>=4000 cells/μL.
- Hemoglobin ≥9.0 gm/dL.
- Platelets ≥75,000 cells/μL.
- Renal Function \> 30 Epithelial Growth Factor Receptor (eGFR).
Exclusion criteria
- Evidence of pelvic regional or distant metastatic disease on conventional imaging (MRI, computed tomography or whole body bone scan) or prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) imaging. PSMA-avid lymph nodes confined to the pelvis will be allowed if \<1 centimeter (cm).
- 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 mm Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
- Contraindication to or inability to tolerate MRI with endorectal coil (e.g. severe claustrophobia, presence of cardiac pacemaker, aneurysm clip, severe or painful hemorrhoids, rectal stricture).
- Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
- History of clinically significant ECG abnormality, including QT prolongation, a family history of prolonged QT interval syndrome or myocardial infarction within 6 months of study entry.
Where
- San Francisco, California
Collaborators
National Cancer Institute (NCI)
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 Jan 7, 2026 · Source of record for eligibility and locations