RecruitingPhase 2NCT06391034

Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer

A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer Undergoing Radiation Therapy


Sponsor

Robert Bok, MD, PhD

Enrollment

161 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 clinical study of hyperpolarized (HP) 13C-pyruvate (13C), 15N-urea (13C,15N) metabolic MR imaging in prostate cancer patients who are undergoing or have received radiation therapy for prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of MRI scan using a special contrast agent made from carbon — called hyperpolarized 13C-pyruvate — to better visualize prostate cancer and how it responds to radiation treatment. It may help doctors understand whether radiation is working. **You may be eligible if...** - You are 18 or older - You have been diagnosed with prostate cancer (confirmed by biopsy) - You are scheduled for or considering external beam radiation therapy (EBRT) - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You cannot consent to or comply with study procedures - You do not meet the specific requirements for your assigned study group (e.g., specific PSA levels or cancer stage criteria) 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 pyruvate +/-urea (13C/15N)

Given IV

RADIATIONNon-investigational External beam radiotherapy (EBRT)

External beam radiotherapy given outside of this study

PROCEDURERadiotherapy (RT)

Radiation therapy given outside of this study

PROCEDUREMulti-parametric magnetic resonance imaging (mpMRI)

Imaging scan

BIOLOGICALNon-interventional hormone therapy

Therapy given outside of this study as part of standard of care

PROCEDUREProstate Biopsy

Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06391034


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