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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 (Jun 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 Jun 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

Treatments studied

Endocrine / hormonal

Abiraterone acetate

Other

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

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.

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Frequently asked questions

Is NCT06384222 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage HIGH-RISK or CN1 or T3 OR HIGHER is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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