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

NCT06384222 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Abiraterone acetate

Given orally

DRUG

Prednisone

Given orally

DRUG

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

Given IV

PROCEDURE

Magnetic Resonance Imaging (MRI)

Imaging procedure

PROCEDURE

Non-investigational radical prostatectomy (RP)

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

PROCEDURE

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

Imaging procedure

Sponsors & Collaborators

  • Ivan de Kouchkovsky, MD

    lead OTHER

Principal Investigators

  • Ivan de Kouchkovsky, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06384222 on ClinicalTrials.gov