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MR Imaging with Pyruvate for Prostate Cancer (pyruvate Trial)

Phase < 1

Recruiting

Led By Rahul Aggarwal, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)

Must not have

Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy

Congestive heart failure or New York Heart Association (NYHA) status >= 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon C13 pyruvate works in finding and diagnosing localized high-grade prostate cancer in patients undergoing radical prostatectomy.

Who is the study for?

This trial is for men with biopsy-proven prostate cancer who are planning a radical prostatectomy at UCSF within 12 weeks. They must have good blood counts, liver and kidney function, and be able to undergo MRI/MRSI. Men with severe allergies, heart conditions, or those unable to give consent are excluded.

What is being tested?

The study tests if Magnetic Resonance Spectroscopic Imaging (MRSI) using hyperpolarized carbon C13 pyruvate can accurately identify high-grade localized prostate cancer in patients scheduled for surgery.

What are the potential side effects?

Potential side effects may include discomfort from the endorectal coil used during MRSI and reactions to gadolinium contrast if applicable. However, specific side effects related to hyperpolarized C13 pyruvate are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidneys are functioning well enough to clear waste.

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My prostate cancer was confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have certain rectal procedures due to past surgery or allergies.

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I have heart failure or my condition limits my physical activity.

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I cannot have gadolinium contrast due to an allergy or kidney issues.

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I have had prostate cancer treatments but not TURP.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Urea AUC by Pathological grade

Mean lactate area under curve (AUC) by Pathological grade

Mean peak conversion of HP 13C pyruvate to lactate (kPL) by Pathological grade

+2 more

Secondary study objectives

Compare lactate/pyruvate area under curve (AUC) with Prostate Imaging Reporting and Data System (PI-RADS)

Compare peak lactate/pyruvate with PI-RADS

Compare pyruvate to lactate (kPL) with PI-RADS

+13 more

Side effects data

From 2019 Phase 1 trial • 9 Patients • NCT03565367

33%

Anosmia

33%

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Healthy Volunteers

Known CNS Malignancy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pre-surgical Prostate Cancer patientsExperimental Treatment3 Interventions

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-interventional radical prostatectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Spectroscopic Imaging

2012

Completed Phase 1

~430

0 / 7Eligibility criteria met