RecruitingPhase 2NCT06384222

Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone

Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) as a Response Monitoring Tool in Patients With High-Risk Prostate Cancer Receiving Neoadjuvant Therapy


Sponsor

Ivan de Kouchkovsky, MD

Enrollment

32 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the use of hyperpolarized 13C MRI (HP 13C MRI) and the HP-derived 13C pyruvate-to-lactate conversion rate constant (kPL) as an early response biomarker in men with treatment-naïve, high-risk, localized or locally advanced prostate cancer receiving neoadjuvant therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of MRI scan called hyperpolarized carbon-13 pyruvate MRI to monitor how prostate cancer responds to hormone therapy (abiraterone) given before surgery. The goal is to find a better way to predict treatment success without waiting for surgery. **You may be eligible if...** - You are 18 or older - You have confirmed high-risk prostate cancer (high Gleason grade, lymph node involvement, or advanced stage) - You are planning to have surgery to remove your prostate - You have not received previous prostate cancer treatment - Your organ function meets required thresholds **You may NOT be eligible if...** - You cannot have an MRI (e.g., you have a pacemaker or certain metal implants) - You are allergic to gadolinium contrast dye used in MRI - You have poorly controlled high blood pressure or significant heart disease - You are currently on certain medications that interfere with the study drug 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

DRUGAbiraterone acetate

Given orally

DRUGPrednisone

Given orally

DRUGHyperpolarized [1-13C] pyruvate (HP 13C)

Given IV

PROCEDUREMagnetic Resonance Imaging (MRI)

Imaging procedure

PROCEDURENon-investigational radical prostatectomy (RP)

Planned, standard of care surgical procedure occurring outside of this study.

PROCEDUREProstate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT)

Imaging procedure


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06384222


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