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OncoMatch/Clinical Trials/NCT02526368

Pilot Study of (MR) Imaging with Pyruvate (13C) to Detect High Grade Prostate Cancer

Is NCT02526368 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Hyperpolarized 13C-Pyruvate and Hyperpolarized 13C,15N2-urea for prostate cancer.

Early Phase 1RecruitingIvan de Kouchkovsky, MDNCT02526368Data as of May 2026

Treatment: Hyperpolarized 13C-Pyruvate · Hyperpolarized 13C,15N2-ureaThis pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: cryosurgery

Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed.

Cannot have received: surgery for prostate cancer

Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed.

Cannot have received: prostatic or pelvic radiotherapy

Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed.

Cannot have received: androgen deprivation therapy

Current or prior androgen deprivation therapy. For Cohort A, a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry. For cohort B, a history of use of 5-α reductase inhibitor is allowed, provided it is discontinued at least 14 days to protocol MRI/MRSI.

Cannot have received: transurethral prostatic resection (TURP)

prior transurethral prostatic resection (TURP) is not allowed

Lab requirements

Blood counts

Absolute neutrophil count (ANC) >= 1500 cells/microliter (uL); Hemoglobin >= 9.0 mg/dL; Platelets >= 75,000 cells/uL

Kidney function

Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)

Liver function

Bilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert's is suspected); AST and ALT < 1.5 x ULN

Absolute neutrophil count (ANC) >= 1500 cells/microliter (uL); Hemoglobin >= 9.0 mg/dL; Platelets >= 75,000 cells/uL; Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation); Bilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert's is suspected); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x ULN

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

US trial sites

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

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