Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance

NCT03933670 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 175516NCI-2018-02195R01CA211150R01EB017449U01CA232320-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Imaging

Outcome Measures

Primary Outcomes (5)

• Signal-to-noise ratio (SNR) of hyperpolarized lactate

  Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics.

  At Baseline

• Intra-tumoral C-pyruvate to lactate (kPL)

  Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics

  At Baseline

• Intra-tumoral C-pyruvate to glutamate (kPG)

  Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics

  At Baseline

• Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade

  kPL will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPL will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.

  Within 12 weeks following baseline HP C-13 pyruvate MR exam

• Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade

  kPG will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPG will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.

  Within 12 weeks following baseline HP C-13 pyruvate MR exam

Secondary Outcomes (7)

• Intra-patient variability in kPL

  Up to 15 months

• Intra-patient variability in kPG

  Up to 15 months

• Contrast between kPL and kPG in regions of tumor

  Up to 15 months

• Comparison of kPL and kPG with apparent diffusion coefficient in region of tumor

  Up to 15 months

• Incidence of adverse events graded

  Up to 15 months

Study Arms (1)

Diagnostic (HP C-13 MRI)

EXPERIMENTAL

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.

Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: MRI Ultrasound Fusion Guided Biopsy

Interventions

Magnetic Resonance Spectroscopic Imaging PROCEDURE

Undergo MRSI

Also known as: Hydrogen-1 (1H)- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging

Diagnostic (HP C-13 MRI)

MRI Ultrasound Fusion Guided Biopsy PROCEDURE

Undergo MR/US fusion-guided prostate biopsy

Also known as: Fusion Biopsy, Fusion Guided Biopsy, Fusion-Guided Biopsy, MR Fusion Biopsy, MRI-Ultrasound Fusion Biopsy, MRI/Ultrasound Fusion Biopsy, MRI/US Biopsy

Diagnostic (HP C-13 MRI)

Hyperpolarized Carbon C 13 Pyruvate DRUG

Given IV

Also known as: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Diagnostic (HP C-13 MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of California, San Francisco: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Hydrogen

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Elements; Inorganic Chemicals; Gases

Study Officials

• Ivan de Kouchkovsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Magat

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: May 1, 2019
• Study Start: July 18, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)