Prostate CancerPhase 2NCT04698564

Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

A Phase 2 study testing Hyperpolarized 13C-Pyruvate in people with Prostate Cancer, run by University of Maryland, Baltimore at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population Read more about this study

Who is it for?: Ages 40 to 80 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Hyperpolarized 13C-Pyruvate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 5 Dec 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age greater than 40 and less than 80 years
Clinical suspicion or history of prostate cancer reflected by one of the following:
PSA > 4ng/ml
Abnormal DRE exam
Known tissue diagnosis of prostate cancer from prior workup
Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment

Who cannot join

Inability to undergo MRI scan
Inability to receive IV contrast as per institutional protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland Medical Center
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer

Conditions: Prostate Cancer
Being tested: 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 13C-PyruvateDrug
Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") [ 13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy.
Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997].

Study groups in NCT04698564
Study group	Role	What they receive
Single-arm study in patients who are suspected or known to have prostate cancer	Experimental	Perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population Receives: Drug: Hyperpolarized 13C-Pyruvate

What is being measured

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

CTCAE v4.0 Higher Than Grade 2
Quantify the number of participants who get this scan and have treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2. Determine the number of participants who successfully complete a scan which meets a minimum quality standard as measured by signal to noise ratio on the scan, hyperpolarized metabolic MRI in the diagnosis of prostate cancer.
Measured: Within three years post treatment

Secondary outcomes (3)

Accuracy of Metabolic MRI to Diagnose Prostate Cancer
To study the accuracy of hyperpolarized metabolic MRI to diagnose prostate cancer. Compare the prediction of cancer from the MRI scan compared to actual diagnosis of cancer by any subsequent workup or procedure the participant undergoes. Prediction of cancer from MRI scan will be performed by assigning a standardized score (PIRADS v2.0). Actual diagnosis of cancer will be based on tissue pathology (with cancer grade characterized using the prostate cancer ISUP Grade Group system) from any procedure the patient undergoes.
Measured: Within three years post treatment
Utility of Metabolic MRI Over Standard MRI Imaging in the Diagnosis of Prostate Cancer
To examine the added utility of metabolic MRI over standard MRI imaging. Quantify the number of participants in which the MRI provided extra information that otherwise was not available during the course of the patient's workup.
Measured: Within three years post treatment
Correlative Metabolic Analysis of Tissue Metabolite Concentrations Versus Cancer Diagnosis
To perform correlative metabolic analysis related to cancer diagnosis. Using the research tissue when it is available. Analyze tumor samples when available from participants and characterize the metabolite concentration (microgram/mg of tissue) within the tumor to determine how the concentration value compares to two outcomes of interest: 1: the numerical suspicion score (PIRADS v2.0 system) from the imaging from the patient and 2: The presence of cancer and grade of cancer (ISUP Grade Group system), when present, from pathology analysis performed on the tissue from the patient available. Analyze tumor samples when available from participants and characterize the metabolite concentration within the tumor to determine how this compares to the information from the imaging from the patient and pathology analysis performed on the tissue
Measured: Within three years post treatment

Timeline

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

1 Dec 20205 Dec 2025

First posted7 Jan 2021
Study start1 Dec 2020
Primary completion5 Dec 2025
Study completion5 Dec 2025

Why it stopped: "Study terminated due to institutional resource constraints, including limited availability of specialized equipment and technical support. Termination was not related to participant safety, data quality, study conduct, or the investigational product

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04698564
Sponsor's protocol ID: 18149GCCC ; HP-00084316
Status last verified: Jul 2026
First submitted: 1 Oct 2020
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer
ClinicalTrials.gov ID: NCT04698564
Acronym / sponsor ID: 18149GCCC ; HP-00084316
Conditions: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: "Study terminated due to institutional resource constraints, including limited availability of specialized equipment and technical support. Termination was not related to participant safety, data quality, study conduct, or the investigational product
Enrolment: 4 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 1 Dec 2020 (actual)
Primary completion: 5 Dec 2025 (actual)
Study completion: 5 Dec 2025 (actual)
First posted: 7 Jan 2021 (actual)
Results: Posted 15 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single-arm study in patients who are suspected or known to have prostate cancer	Experimental	Drug: Hyperpolarized 13C-PyruvatePerform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population

Who may qualify

Ages: 40 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age greater than 40 and less than 80 years
Clinical suspicion or history of prostate cancer reflected by one of the following:
Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment

Key exclusion criteria (2 listed)

Inability to undergo MRI scan
Inability to receive IV contrast as per institutional protocol.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyperpolarized 13C-PyruvateHyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") [ 13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy. Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997].	Drug	Single-arm study in patients who are suspected or known to have prostate cancer

Primary outcome

CTCAE v4.0 Higher Than Grade 2
Time frame: Within three years post treatment
Quantify the number of participants who get this scan and have treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2. Determine the number of participants who successfully complete a scan which meets a minimum quality standard as measured by signal to noise ratio on the scan, hyperpolarized metabolic MRI in the diagnosis of prostate cancer.

3 secondary outcomes

Accuracy of Metabolic MRI to Diagnose Prostate Cancer
Time frame: Within three years post treatment
Utility of Metabolic MRI Over Standard MRI Imaging in the Diagnosis of Prostate Cancer
Time frame: Within three years post treatment
Correlative Metabolic Analysis of Tissue Metabolite Concentrations Versus Cancer Diagnosis
Time frame: Within three years post treatment

Results and safety

Results posted to the registry on 15 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer	4	3

Primary outcome: CTCAE v4.0 Higher Than Grade 2

Time frame: Within three years post treatment. Count of participants. Unit: Participants

Measure	Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer n = 3
Value	0

Population analysed: This study was terminated prematurely. No patients had treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2 until study termination. Four participants were enrolled; however, no usable data were obtained. * One withdrew before the visit * One could not complete the HP MRI due to pyruvate QC failure, so the HP scan was not completed. * Two patients completed scans, but the SNR was too low (below minimum quality standard) for analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of study entry through 3 month follow- up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): The study was terminated prematurely. Protocol closure was submitted in September 2025, and the protocol expired prior to local IRB acknowledgment in December 2025; however, all enrolled participants had completed the study before closure submission. No updated consent form was available. Additionally, imaging signal-to-noise ratio (SNR) was below minimum quality standards, indicating technical limitations that may affect data quality.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyperpolarized 13C-Pyruvate in people with Prostate Cancer, run by University of Maryland, Baltimore 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Jul 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?

Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CTCAE v4.0 Higher Than Grade 2 (time frame: Within three years post treatment). 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 NCT04698564.

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 15 Jul 2026.