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

Part of paid clinical trials in San Francisco, California.

Sponsor
Ivan de Kouchkovsky, MD
Study ID
NCT06384222
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone acetate — DRUG
    Given orally
  • Prednisone — DRUG
    Given orally
  • Hyperpolarized [1-13C] pyruvate (HP 13C) — DRUG
    Given IV
  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Imaging procedure
  • Non-investigational radical prostatectomy (RP) — PROCEDURE
    Planned, standard of care surgical procedure occurring outside of this study.
  • Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT) — PROCEDURE
    Imaging procedure

Study Details

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.

Key Dates

Start date
Dec 9, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
    Neoadjuvant abiraterone (1000mg) will be administered for three 28-day cycles, in conjunction with 5mg of prednisone. Participants will undergo a paired multi-parametric/hyperpolarized MRI of the prostate at screening, cycle 2 day 1, and after completion of neoadjuvant therapy. With each scan, a hyperpolarized 13C-pyruvate injection will be administered and an endorectal coil will be inserted prior to and removed after completion of the 1H and 13C MR exam using standard institutional procedures for preparation and placement for enhanced imaging. A planned, non-investigational RP will be completed within 7-56 days after last dose/discontinuation of neoadjuvant study drug. Participants will be followed up until death, withdrawal of consent, or end of study, whichever occurs first.

Primary Outcome Measure

Mean changes in intratumoral pyruvate-to-lactate conversion rate constant (kPL) [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Maya Aslam
[email protected]
(415) 514-8987
[email protected]
877-827-3222
Ivan de Kouchkovsky, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Francisco· San Francisco, CA

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