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OncoMatch/Clinical Trials/NCT06384222

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

Is NCT06384222 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Abiraterone acetate and Prednisone for high risk prostate carcinoma.

Phase 2RecruitingIvan de Kouchkovsky, MDNCT06384222Data as of May 2026

Treatment: Abiraterone acetate · Prednisone · Hyperpolarized [1-13C] pyruvate (HP 13C)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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Required: Stage HIGH-RISK, CN1, T3 OR HIGHER

Excluded: Stage DISTANT METASTATIC DISEASE

Grade: Gleason grade group >=4 (Gleason)

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

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: prostate cancer therapy

Exception: Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to first dose.

Has received prior prostate cancer therapy. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to first dose.

Lab requirements

Blood counts

Absolute neutrophil count (ANC) >=1,500/mcL. Platelets >=100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start.

Kidney function

Estimated creatinine clearance >=40 mL/min (by the Cockcroft Gault equation).

Liver function

Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. AST/SGOT <=3 X institutional upper limit of normal. ALT/SGPT <=3 X institutional upper limit of normal.

Demonstrates adequate organ function as defined below: 1. Absolute neutrophil count (ANC) >=1,500/mcL. 2. Platelets >=100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start. 3. Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. 4. AST/SGOT <=3 X institutional upper limit of normal. 5. ALT/SGPT <=3 X institutional upper limit of normal. 6. Estimated creatinine clearance >=40 mL/min (by the Cockcroft Gault equation).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California, San Francisco · San Francisco, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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