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Pilot Study of Imaging with Pyruvate (13C) for High-Grade Prostate Cancer

This study is looking at how well a special type of imaging, called magnetic resonance spectroscopic imaging (MRSI), can find high-grade prostate cancer that hasn't spread. Researchers are using two substances given through an IV: Hyperpolarized 13C-Pyruvate alone, or in combination with Hyperpolarized 13C,15N2-urea. They want to see if these substances help MRSI tell the difference between high-grade and low-grade prostate cancer, and healthy prostate tissue. You might be able to join if you are a man aged 18 or older with prostate cancer that has been confirmed by a biopsy. The study aims to enroll 80 participants and is currently unclear if it is recruiting.

Study design
This is an interventional pilot study with a planned enrollment of 80 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive Hyperpolarized 13C-Pyruvate and/or Hyperpolarized 13C,15N2-urea intravenously and undergo Magnetic Resonance Spectroscopic Imaging. Measurements will be taken at baseline and one day later.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken at baseline and one day after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02526368

Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Ivan de Kouchkovsky, MD
~80 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Hyperpolarized 13C-PyruvateHyperpolarized 13C,15N2-ureaMagnetic Resonance Spectroscopic Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio by pathological grade (Cohort A)
Measured over Baseline, 1 day
+9 more outcomes measured

Conditions

Prostate Cancer
Localized Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ivan de Kouchkovsky, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Louise Magat
[email protected]
(415) 502-1822
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of University of California, San Francisco (UCSF), if detailed results of sextant biopsy are available. For Cohort A only, a minimum of 20 participants out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.
Cohort A only: Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI.
Cohort B only: HIFU focal therapy completed within 18 months of protocol MRI/MRSI, and planned systematic and MR-guided biopsy at UCSF within 12 weeks following protocol MRI/MRSI.
The participant 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

Exclusion

Participants who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
Participants who cannot tolerate or have contra-indications to endorectal coil insertion; for example, participants with a prior abdominoperineal resection of the rectum or latex allergy.
Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.
Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed. No limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed.
Current or prior androgen deprivation therapy. For Cohort A, a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry. For cohort B, a history of use of 5-α reductase inhibitor is allowed, provided it is discontinued at least 14 days to protocol MRI/MRSI.
Poorly controlled hypertension, with blood pressure at study entry \> 160/100; the addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
Congestive heart failure or New York Heart Association (NYHA) status \>= 2.
A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation/flutter will be allowed on study.

What this trial measures

  • Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio by pathological grade (Cohort A)Baseline, 1 day

    Means and standard deviations for lactate area under curve will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)).

  • Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio (Cohort B)Baseline, 1 day

    Means and standard deviations for lactate area under curve will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.

  • Mean lactate area under curve (AUC) by pathological grade (Cohort A)Baseline, 1 day

    Means and standard deviations for lactate area under curve will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)). A One-way ANOVA model will be used to compare lactate area under curve by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)).

  • Mean lactate area under curve (AUC) (Cohort B)Baseline, 1 day

    Means and standard deviations for lactate area under curve will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.

  • Mean peak conversion of HP 13C pyruvate to lactate (kPL) by pathological grade (Cohort A)Baseline, 1 day

    Means and standard deviations for kPL will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)).

  • Mean peak conversion of HP 13C pyruvate to lactate (kPL) (Cohort B)Baseline, 1 day

    Means and standard deviations for kPL will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.

  • Mean Urea AUC by pathological grade (Cohort A)Baseline, 1 day

    Means and standard deviations for Urea AUC will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)).

  • Mean Urea AUC (Cohort B)Baseline, 1 day

    Means and standard deviations for Urea AUC will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.

  • Mean urea transfer constant (Ktrans) by pathological grade (Cohort A)Baseline, 1 day

    Means and standard deviations for Ktrans will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)).

  • Mean urea transfer constant (Ktrans) (Cohort B)Baseline, 1 day

    Means and standard deviations for Ktrans will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.