RecruitingEarly Phase 1NCT02526368

Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer

A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer


Sponsor

Ivan de Kouchkovsky, MD

Enrollment

80 participants

Start Date

Mar 22, 2016

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special MRI scan using a naturally occurring substance (pyruvate, labeled with carbon-13) can accurately detect high-grade prostate cancer before surgery or after a focused treatment called HIFU (high-intensity focused ultrasound). **You may be eligible if...** - You are a man with biopsy-confirmed prostate cancer - You are either scheduled for prostate removal surgery (radical prostatectomy) at UCSF, or you recently had HIFU focal therapy and are scheduled for a follow-up biopsy - You are in good general health (ECOG performance status 0 or 1) - Your blood counts, kidney function, and liver function are within acceptable ranges **You may NOT be eligible if...** - You are under 18 years old or have conditions that prevent you from giving informed consent - You cannot have an MRI (e.g., you have a pacemaker or metal implants) - You are allergic to gadolinium contrast dye or have poor kidney function - You have a latex allergy or prior rectal surgery that prevents use of an endorectal coil (part of the MRI setup) - You have previously had surgery, radiation, or hormone therapy for prostate cancer (HIFU is allowed for one group) - You have uncontrolled high blood pressure, congestive heart failure, or a history of heart attack in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHyperpolarized 13C-Pyruvate

Given IV

DRUGHyperpolarized 13C,15N2-urea

Given IV

PROCEDUREMagnetic Resonance Spectroscopic Imaging

Undergo MRSI


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT02526368


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