AzTrials
AzTrials

Prostate CancerPhase 2NCT06391034

Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer

A Phase 2 study testing hyperpolarized pyruvate +/-urea (13C/15N), Non-investigational External beam radiotherapy (EBRT) and Radiotherapy (RT) in people with Prostate Cancer, run by Robert Bok, MD, PhD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
hyperpolarized pyruvate +/-urea (13C/15N), Non-investigational External beam radiotherapy (EBRT) and Radiotherapy (RT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteUnited States
Study dates
24 Sep 2024to 31 Oct 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have biopsy-proven adenocarcinoma of the prostate, as determined by medical chart review.
  • For:
  • 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.
Show all 15Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Louise Magat contact

(415) 502-1822

Louise.Magat@ucsf.edu

United States1 site, 1 recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Louise Magat, (415) 502-1822, Louise.Magat@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer Undergoing Radiation Therapy

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Part 1: To Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral kPL and kPG in regions of tumor vs. adjacent benign tissue as assessed by mpMRI imaging characteristics.

II. Part 2A To perform HP 13C-MRI and measure the changes in tumoral kPL and kPG.

III. Part 2B: To perform HP 13C-MRI and study the metabolic effects (changes in tumor kPL and kPG).

IV. Part 3: To perform HP 13C-MRI at time of Biochemical Failure and measure tumoral kPL and kPG, in previously external beam radiation therapy (EBRT) treated patients.

SECONDARY OBJECTIVES:

  1. To evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies (Part 1, 2 \& 3).

II. To determine the association between peak intra-tumoral kPL observed on baseline imaging with serum PSA. (Part 2 \& 3).

III. To determine the association between changes in intra-tumor kPL after 4-12 weeks of systemic hormone therapy and PSA response (Part 2B).

IV. To compare and contrast intra-tumoral kPL and kPG with Prostate Imaging Reporting and Data System (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging (Part 1, 2 \& 3).

  1. To describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP-MRI exam. (Part 3).

VI. To further characterize the safety profile of HP C-13 pyruvate injections (Part 1, 2 \& 3).

VII. For patients imaged with HP 13C-MRI at time of biochemical failure post-EBRT, correlate peak intra-tumoral kPL and kPG with radiotherapy dose distributions from EBRT course (Part 3).

VIII. For studies incorporating HP 13C-urea, the baseline and the on-treatment changes in urea AUC parameter will be measured and compared to kPL endpoints of the same lesions (Part 1, 2 \& 3).

OUTLINE:

The study is divided into 3 parts. Part 1: Participants undergo imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam to determine exact parameters for imaging.

Part 2A: Participants planned for external beam radiotherapy (EBRT) Part 2B: Participants with high-risk localized prostate cancer planned to receive primary radiation therapy with concurrent systemic hormone therapy Part 3: Evaluable EBRT participants scanned at time of biochemical failure and MR/US fusion-guided prostate biopsy within 12 weeks. Participants have the option of undergoing a follow up HP Pyruvate +/- Urea MR exam 6-15 months following the baseline scan.

All participants will receive a scan at baseline and other procedures may be performed as part of routine, non-interventional standard of care at the time of biochemical failure, including serial prostate-specific antigen (PSA) monitoring and gene expression profiling of tumor tissue. Participants will be followed for 24 months after last procedure or removal from study, or until death, whichever occurs first.

Conditions
Prostate Cancer
Being tested
hyperpolarized pyruvate +/-urea (13C/15N), Non-investigational External beam radiotherapy (EBRT), Radiotherapy (RT), Multi-parametric magnetic resonance imaging (mpMRI), Non-interventional hormone therapy
Keywords
Imaging Studies, Hyperpolarized 13C-Pyruvate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hyperpolarized pyruvate +/-urea (13C/15N)Drug

    Also called 13C-Pyruvate,15N-urea

    Given IV

  • Non-investigational External beam radiotherapy (EBRT)Radiation

    Also called EBRT

    External beam radiotherapy given outside of this study

  • Radiotherapy (RT)Procedure or surgery

    Also called RT

    Radiation therapy given outside of this study

  • Multi-parametric magnetic resonance imaging (mpMRI)Procedure or surgery

    Also called mpMRI

    Imaging scan

  • Non-interventional hormone therapyBiological

    Also called Non-interventional, systemic hormone therapy

    Therapy given outside of this study as part of standard of care

  • Prostate BiopsyProcedure or surgery

    Also called Biopsy

    Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion

Study groups in NCT06391034
Study groupRoleWhat they receive
Part 1: Image Optimization GroupExperimentalParticipants will undergo Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam, with the primary objective of optimizing imaging sequences and techniques to maximize signal-to-noise ratio of imaging modality.
Receives: Drug: hyperpolarized pyruvate +/-urea (13C/15N); Procedure: Multi-parametric magnetic resonance imaging (mpMRI)
Part 2A: Prospective imaging (External beam radiotherapy (EBRT) Participants)ExperimentalParticipants with pre-planned, non-interventional stereotactic body radiotherapy (EBRT) will undergo an HP Pyruvate +/-Urea mpMRI exam at baseline, at 3 months post-EBRT treatment and at 1yr post-treatment.
Receives: Drug: hyperpolarized pyruvate +/-urea (13C/15N); Radiation: Non-investigational External beam radiotherapy (EBRT); Procedure: Multi-parametric magnetic resonance imaging (mpMRI)
Part 2B: Prospective imaging (High-risk localized prostate cancer)ExperimentalParticipants with with high-risk localized prostate cancer and have pre-planned, non-interventional primary radiation therapy (RT) with concurrent, systemic, non-interventional hormone therapy will undergo HP Pyruvate+/-Urea mpMRI at baseline prior to the start of systemic hormone therapy, 4-12 weeks after the initiation of systemic hormone therapy (prior to radiation therapy), at 3 months post-radiation therapy, and at +1yr post-radiation therapy.
Receives: Drug: hyperpolarized pyruvate +/-urea (13C/15N); Procedure: Radiotherapy (RT); Procedure: Multi-parametric magnetic resonance imaging (mpMRI); Biological: Non-interventional hormone therapy
Part 3: EBRT participants at time of biochemical recurrence (BCR)ExperimentalEvaluable EBRT participants who undergo HP Pyruvate +/-Urea mpMRI at time of biochemical failure, followed by magnetic resonance (MR) / ultrasound (US) fusion-guided prostate biopsy within 12 weeks following baseline MR exam. Participants in this group have the option of undergoing a follow up HP Pyruvate +/-Urea MR exam 6-15 months following the baseline scan, to evaluate for any interval change.
Receives: Drug: hyperpolarized pyruvate +/-urea (13C/15N); Radiation: Non-investigational External beam radiotherapy (EBRT); Procedure: Multi-parametric magnetic resonance imaging (mpMRI); Procedure: Prostate Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Signal-to-noise ratio (Part 1)

    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.

    Measured: Day of MR imaging (1 day)

  2. Mean HP 13C-pyruvate to lactate metabolic rate of conversion (kPL) over time (Part 2A)

    The mean percent change in tumoral kPL between baseline and 1-year post-EBRT will be reported.

    Measured: Up to 24 months

  3. Mean HP 13C-pyruvate to glutamate metabolic rate of conversion (kPG) over time (Part 2A)

    The mean percent change in tumoral kPG between baseline and 1-year post-EBRT will be reported.

    Measured: Up to 24 months

  4. Mean change in on-treatment kPL over time (Part 2B)

    Mean percent change in tumoral kPL for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported.

    Measured: Up to 24 months

  5. Mean change in on-treatment kPG over time (Part 2B)

    Mean percent change in tumoral kPG for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported.

    Measured: Up to 24 months

  6. Mean kPL at time of biochemical failure (Part 3)

    The mean kPL for participants with biochemical failure will be reported.

    Measured: Up to 24 months

  7. Mean kPG at time of biochemical failure (Part 3)

    The mean kPG for participants with biochemical failure will be reported.

    Measured: Up to 24 months

Secondary outcomes (8)

  1. Intra-patient variability of kPL

    Intra-patient variability in the kPL will be summarized by the intraclass correlation and presented with a 90% confidence interval when multiple HP-MRI scans are obtained for a participant.

    Measured: Up to 12 months

  2. Intra-patient variability of kPG

    Intra-patient variability in the kPG will be summarized by the intraclass correlation and presented with a 90% confidence interval when multiple HP-MRI scans are obtained for a participant.

    Measured: Up to 12 months

  3. Mean intra-tumoral kPL above and below the median PSA (Parts 2-3) and the mean serum PSA

    The study cohort will be dichotomized by mean intra-tumoral kPL obtained at baseline with median serum PSA and will be compared between the two dichotomized subgroups using Mann-Whitney test.

    Measured: Up to 24 months

  4. Correlation of kPL with Prostate Imaging Reporting and Data System (PI-RADS) version 2 classification score

    Spearman's rank order correlation coefficient will be used to determine the relationship between kPL with PI-RADS version 2 classification score (1 through 5; PI-RADS 1 - Very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2 - Low (clinically significant cancer is unlikely to be present)). The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association.

    Measured: Up to 24 months

  5. Correlation of kPG with PI-RADS version 2 classification score

    Spearman's rank order correlation coefficient will be used to determine the relationship between kPL with PI-RADS version 2 classification score (1 through 5; PI-RADS 1 - Very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2 - Low (clinically significant cancer is unlikely to be present)). The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association.

    Measured: Up to 24 months

  6. Proportion of participants with concordant mismatch of low HP 13C-urea perfusion (ureaAUC)

    A secondary endpoint will be to identify concordant mismatch of low HP 13C-urea perfusion (ureaAUC) in lesions assessed for kPL.

    Measured: Up to 24 months

  7. Mean percent change in kPL over time for participants with optional scan

    For the subset of participants who undergo optional follow up MR scan following baseline MRI, the mean percent change from baseline in kPL will be descriptively reported using summary statistics.

    Measured: Up to 24 months

  8. Number of participants with reported treatment-related adverse events

    The incidence of adverse events as graded by Common Toxicity Criteria version 5.0 will be determined

    Measured: From start of HP 13C-pyruvate MR imaging to 20 minutes after the procedure for all scans

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start24 Sep 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Oct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06391034
Sponsor's protocol ID
24922
Other IDs
5R01CA238379, NCI-2024-03775
Status last verified
Dec 2025
First submitted
25 Apr 2024
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hyperpolarized pyruvate +/-urea (13C/15N), Non-investigational External beam radiotherapy (EBRT) and Radiotherapy (RT) in people with Prostate Cancer, run by Robert Bok, MD, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Louise Magat ((415) 502-1822, Louise.Magat@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Signal-to-noise ratio (Part 1) (time frame: Day of MR imaging (1 day)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06391034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in