Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) as a Response Monitoring Tool in Patients With High-Risk Prostate Cancer Receiving Neoadjuvant Therapy
Ivan de Kouchkovsky, MD
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.
Description
PRIMARY OBJECTIVE: I. To investigate on-treatment changes in HP 13C MRI derived kPL as an early response biomarker in men with high-risk localized or locally advanced prostate cancer receiving neoadjuvant abiraterone/prednisone prior to radical prostatectomy (RP). SECONDARY OBJECTIVES: I. To evaluate the pathologic complete response/minimal residual disease rate at the time of radical prostatectomy following 12 weeks of neoadjuvant abiraterone/prednisone in patients with high-risk localized or locally advanced prostate cancer. II. To determine the safety and tolerability of neoadjuvant abi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Greater than or equal to 18 years of age 2. Histologically confirmed adenocarcinoma of the prostate with archival biopsy tissue (collected within 12 months of cycle 1 day 1 of treatment) available for genomic profiling. a. Tumor tissue does not need to be retrieved but rather identified and available upon later request for future pathologic review and possible correlative studies. 3. High-risk disease defined as meeting 1 or more of the 3 following criteria: 1. Gleason grade group \>=4; or 2. Pelvic node involvement by conventional imaging or PSMA PET imaging…
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
Location
- University of California, San FranciscoSan Francisco, California