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Recruiting Phase 2 NCT06384222

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

Trial Parameters

Condition High Risk Prostate Carcinoma
Sponsor Ivan de Kouchkovsky, MD
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-12-09
Completion 2027-09-30
Interventions
Abiraterone acetatePrednisoneHyperpolarized [1-13C] pyruvate (HP 13C)

Brief 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 Criteria

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 (cN1); or 3. Tumor stage T3 or higher (i.e. tumor extension outside of the prostate, or spread to tissues near the prostate other than the seminal vesicles, such as the bladder or wall of the pelvis) as determined by conventional imaging (including prostate MRI), transrectal ultrasound or PSMA PET imaging. 4. No evidence of distant metastatic disease as determined by PSMA PET/CT or PET/MR. Nodal disease belo

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