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

NCT ID: NCT03933670

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-18
• Study Completion Date: 2026-10-31

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral conversion of HP 13C pyruvate to lactate (kPL) and HP 13C pyruvate to glutamate (kPG) in regions of tumor versus (vs.) adjacent benign tissue as assessed by multi-parametric MRI (mpMRI) imaging characteristics. (Part 1) II. Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance (MR)/ultrasound (US)-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam. (Part 2)

SECONDARY OBJECTIVES:

I. Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies.

II. Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen (PSA).

III. Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging.

IV. Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam.

V. Further characterize the safety profile of HP C-13 pyruvate injections.

EXPLORATORY OBJECTIVES:

I. Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay.

II. Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid (RNA) expression of relevant components of the glycolytic pathway including lactate dehydrogenase (LDH), pyruvate dehydrogenase (PDH), aconitate hydratase (aconitase), myelocytomatosis oncogene (MYC), monocarboxylate transporter 4 (MCT4) (lactate transporter).

III. For patients who undergo optional follow-up HP C-13 pyruvate/MRI 6-15 months following baseline scan, determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California, San Francisco (UCSF)-Cancer of the Prostate Risk Assessment (CAPRA) risk score.

OUTLINE:

Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute, then undergo magnetic resonance spectroscopic imaging (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.

After completion of study, patients will be followed up periodically.

Conditions

Prostate Adenocarcinoma; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyperpolarized Carbon C 13 Pyruvate

Intervention Type: DRUG

Given IV

Magnetic Resonance Spectroscopic Imaging

Intervention Type: PROCEDURE

Undergo MRSI

MRI Ultrasound Fusion Guided Biopsy

Intervention Type: PROCEDURE

Undergo MR/US fusion-guided prostate biopsy

Interventions

Hyperpolarized Carbon C 13 Pyruvate

Given IV

Intervention Type: DRUG

Magnetic Resonance Spectroscopic Imaging

Undergo MRSI

Intervention Type: PROCEDURE

MRI Ultrasound Fusion Guided Biopsy

Undergo MR/US fusion-guided prostate biopsy

Intervention Type: PROCEDURE

Other Intervention Names

Hyperpolarized 13C-Pyruvate; Hyperpolarized Pyruvate (13C); 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; Fusion Biopsy; Fusion Guided Biopsy; Fusion-Guided Biopsy; MR Fusion Biopsy; MRI-Ultrasound Fusion Biopsy; MRI/Ultrasound Fusion Biopsy; MRI/US Biopsy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Ivan de Kouchkovsky, MD

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivan de Kouchkovsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Louise Magat

Role: CONTACT

Louise.Magat@ucsf.edu

(415) 502-1822

Facility Contacts

Louise Magat

Role: primary

Louise.Magat@ucsf.edu

(415) 502-1822

Role: backup

cancertrials@ucsf.edu

877-827-3222

Ivan de Kouchkovsky, MD

Role: backup

Other Identifiers

NCI-2018-02195

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01CA211150

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01EB017449

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01CA232320-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

175516

Identifier Type: -

Identifier Source: org_study_id