Recruiting
Phase 2

Hyperpolarized Pyruvate

Sponsor:

UCLA

Code:

NCT03933670

Conditions

Prostate Adenocarcinoma

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Spectroscopic Imaging

MRI Ultrasound Fusion Guided Biopsy

Study Details

Brief summary:

This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.

Conditions

Prostate Adenocarcinoma

Prostate Cancer

Study ID

NCT03933670

Start date

Jul 18, 2018

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.
  • For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study.
  • The subject 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.
  • Absolute neutrophil count (ANC) >= 1000 cells/microliter (uL).
  • Hemoglobin >= 9.0 gm/deciliter (dL).
  • Platelets >= 75,000 cells/uL.
  • Estimated creatinine clearance\* >= 50 milliliter (mL)/min by the Cockcroft Gault equation.
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) or if =< 3 x ULN if known/suspected Gilbert's
  • Aspartate aminotransferase (AST) =< 1.5 x ULN.
  • Alanine aminotransferase (ALT) =< 1.5 x ULN.

Exclusion Criteria:

  • Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
  • Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
  • Prior radiation treatment of the prostate.
  • 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 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
  • Congestive heart failure with New York Heart Association (NYHA) status >= 2.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (HP C-13 MRI)

Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute, then undergo MRSI after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Given IV

Magnetic Resonance Spectroscopic Imaging

Undergo MRSI

MRI Ultrasound Fusion Guided Biopsy

Undergo MR/US fusion-guided prostate biopsy

Primary outcome measure

  • Signal-to-noise ratio (SNR) of hyperpolarized lactate [ Time Frame: At Baseline ]
  • Intra-tumoral C-pyruvate to lactate (kPL) [ Time Frame: At Baseline ]
  • Intra-tumoral C-pyruvate to glutamate (kPG) [ Time Frame: At Baseline ]
  • Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade [ Time Frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam ]
  • Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade [ Time Frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam ]

Central Contacts and Locations

Central contacts

Louise Magat

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

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Louise Magat

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

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Ivan de Kouchkovsky, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-05-18.