Recruiting
Early Phase 1

Pyruvate (13C)

Sponsor:

Ivan de Kouchkovsky, MD

Code:

NCT02526368

Conditions

Prostate Cancer

Localized Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 13C-Pyruvate

Hyperpolarized 13C,15N2-urea

Magnetic Resonance Spectroscopic Imaging

Study Details

Brief summary:

This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue

Conditions

Prostate Cancer

Localized Prostate Carcinoma

Study ID

NCT02526368

Start date

Mar 22, 2016

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Note: The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criterion will not apply.

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort A: Pre-surgical Prostate Cancer patients

Participants will receive an infusion of hyperpolarized 13C-pyruvate alone or co-hyperpolarized 13C pyruvate with hyperpolarized 13C, 15N urea injection prior to metabolic/perfusion high spatial resolution MRI/1H MRSI staging exam (PROSE) with endorectal coil using both a phased-array abdominal coil and an endorectal coil will be performed within 12 weeks of subsequent non-investigational radical prostatectomy.

experimental: Cohort B: Post-HIFU Participants

Participants will receive an infusion of hyperpolarized 13C-pyruvate alone or co-hyperpolarized 13C pyruvate with hyperpolarized 13C, 15N urea injection prior to metabolic/perfusion high spatial resolution MRI/1H MRSI staging exam (PROSE) with endorectal coil using both a phased-array abdominal coil and an endorectal coil will be performed for participants with planned post-HIFU surveillance systematic and MR-targeted non-investigational biopsies

Interventions

Hyperpolarized 13C-Pyruvate

Given IV

Hyperpolarized 13C,15N2-urea

Given IV

Magnetic Resonance Spectroscopic Imaging

Undergo MRSI

Primary outcome measure

  • Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio by pathological grade (Cohort A) [ Time Frame: Baseline, 1 day ]
  • Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio (Cohort B) [ Time Frame: Baseline, 1 day ]
  • Mean lactate area under curve (AUC) by pathological grade (Cohort A) [ Time Frame: Baseline, 1 day ]
  • Mean lactate area under curve (AUC) (Cohort B) [ Time Frame: Baseline, 1 day ]
  • Mean peak conversion of HP 13C pyruvate to lactate (kPL) by pathological grade (Cohort A) [ Time Frame: Baseline, 1 day ]
  • Mean peak conversion of HP 13C pyruvate to lactate (kPL) (Cohort B) [ Time Frame: Baseline, 1 day ]
  • Mean Urea AUC by pathological grade (Cohort A) [ Time Frame: Baseline, 1 day ]
  • Mean Urea AUC (Cohort B) [ Time Frame: Baseline, 1 day ]
  • Mean urea transfer constant (Ktrans) by pathological grade (Cohort A) [ Time Frame: Baseline, 1 day ]
  • Mean urea transfer constant (Ktrans) (Cohort B) [ Time Frame: Baseline, 1 day ]

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

Ivan de Kouchkovsky, MD

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ivan de Kouchkovsky, MD on 2026-04-30.