A Phase 2 interventional study of Hyperpolarized 13C-Pyruvate in Prostate Cancer, sponsored by University of Maryland, Baltimore. Terminated at 1 site in United States. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Treatment
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 4 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinical suspicion or history of prostate cancer reflected by one of the following:
Exclusion Criteria:
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
Drug: Hyperpolarized 13C-Pyruvate
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 \[Koletzko et al., 1997\].
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.
Time frame: Within three years post treatment
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.
Time frame: 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.
Time frame: 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
Time frame: Within three years post treatment
| Milestone | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| Started | 4 |
| Completed | 3 |
| Not completed | 1 |
| Withdrew: Insurance issues. withdrawn from study | 1 |
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.
| Participants | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| CTCAE v4.0 Higher Than Grade 2 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Collected over From the time of study entry through 3 month follow- up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 1 |
| Age, Continuous(years) | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| Mean | 59 ± 7.53 |
| Sex: Female, Male(Participants) | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| Female | 0 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Single-arm Study in Patients Who Are Suspected or Known to Have Prostate Cancer |
|---|---|
| United States | 4 |
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University of Maryland, Baltimore